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Trial registered on ANZCTR
Registration number
ACTRN12624000898550p
Ethics application status
Submitted, not yet approved
Date submitted
3/07/2024
Date registered
24/07/2024
Date last updated
24/07/2024
Date data sharing statement initially provided
24/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A Study to Investigate the Safety of SEP-786 101 Capsules Compared With Placebo Capsules in Healthy Volunteer Participants Aged 24 Through 55 Years
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Scientific title
A Phase 1, Double Blind, Randomized, Placebo Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Doses of SEP-786 in Healthy Adult Participants (SEP-786 Phase 1 SAD and MAD)
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Secondary ID [1]
312387
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SEP-786-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypoparathyroidism
334190
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Condition category
Condition code
Metabolic and Endocrine
330849
330849
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0
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study will be conducted in to 3 parts. Part 1 will evaluate single ascending doses (SAD) of SEP-786 administered orally as capsule on Day 1 in healthy participants. It will consist of a maximum of 8 cohorts and each cohort will consist of up to 10 healthy participants. Participants will be randomized to SEP-786 or placebo (up to 80 participants total) in 1 of the 8 treatment cohorts. The dose range for SEP-786 will be between 5 mg and 200 mg.
Part 2 will evaluate once-daily multiple ascending doses (MAD) of SEP-786 from Day 1 through 5. It will consist of a maximum of 4 cohorts and each cohort will consist of up to 10 healthy participants. Participants will be randomized to SEP-786 or placebo (up to 40 participants total) in 1 of the 4 treatment cohorts. The dose range for SEP-786 will be between 20 and 80 mg.
Part 3 will evaluate twice-daily MAD of SEP-786 from Day 1 through 5. It will consist of a maximum of 3 cohorts and each cohort will consist of up to 10 healthy participants. Participants will be randomized to SEP-786 or placebo (up to 30 participants total) in 1 of the 3 treatment cohorts. The dose range for SEP-786 will be between 10 and 30 mg.
Sentinel dosing will be used in the Part 1 treatment cohorts (SAD) to evaluate acute post-dosing effects in each arm. Before initiating a new dosing arm, Safety Review Committee will review all available safety, tolerability, and pharmacodynamic (PD), data collected in the previous treatment cohorts. For SAD arms, the data will be assessed through at least Day 4, and for MAD arms, up to at least Day 8. Participants will be closely monitored in the clinical research unit (CRU) for safety monitoring.
The study will be conducted at one site in Australia with safety, serum chemistry, pharmacokinetic, and pharmacodynamics parameters monitored for each participant. The anticipated total duration of the study is approximately 9 months.
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Intervention code [1]
328916
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Treatment: Drugs
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Comparator / control treatment
Placebo microcrystalline cellulose, white opaque, hydroxypropyl methylcellulose (HPMC) capsules.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Part 1, 2 and 3- Incidence of treatment-emergent adverse events (TEAEs)
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Assessment method [1]
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A TEAE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: a. is a congenital anomaly/birth defect; b. results in persistent or significant disability/incapacity; c. requires inpatient hospitalization or prolongation of existing hospitalization; d. is life threatening; e. results in death. Vital signs- systolic and diastolic BP and HR will be assessed while the participant is supine, and, when orthostatic BP is assessed, while standing, with a completely automated device (eg., stethoscope and digital sphygmomanometer etc.). Number of participants with TEAEs, SAE, abnormal vital sign values, abnormal 12-lead ECG values and abnormal physical examination findings will be assessed and reported collectively
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Timepoint [1]
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Part 1, 2 and 3- From study treatment start up to early discontinuation or end of study (up to 15 days)
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Primary outcome [2]
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Part 1, 2 and 3- Change From Baseline in Serum Chemistry Values
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Assessment method [2]
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Serum chemistry (including liver function tests, electrolytes, lipids metabolic and kidney function tests) will be assessed using whole blood samples.
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Timepoint [2]
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Part 1: Baseline, Days 1, 2, 3, 4, and 9 post-dose; Part 2 and 3: Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, and 15 post-dose
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Primary outcome [3]
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Part 1, 2 and 3- Change From Baseline in Hematology Parameters
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Assessment method [3]
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Hematology parameters (including platelet count, RBC count, RBC indices, WBC count, hemoglobin and hematocrit) will be assessed using whole blood samples.
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Timepoint [3]
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Part 1: Baseline, Days 1, 2, 3, 4, and 9 post-dose; Part 2 and 3: Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, and 15 post-dose
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Secondary outcome [1]
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Part 1, 2 and 3- Assessment of pharmacokinetics (PK) parameters: Cmax, Tmax, AUCt, AUC0-inf, t1/2, CL/F, Vz/F
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Assessment method [1]
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Maximum observed serum concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve (AUCt) from time 0 to the last quantifiable time point (AUCt), AUC from time 0 extrapolated to infinity (AUC0-inf), terminal elimination half-life (t1/2) and apparent clearance (CL/F), apparent volume of distribution (Vz/F). Plasma samples will be used to assess PK outcomes.
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Timepoint [1]
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Part 1, Day 1: 0- (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8-, 10-, 12-, 16-, 24-, 48-, and 72- hours post-dose; Part 2, Day 1: 0- (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8-, 12- hours post-dose, Day 2 to 4: 0- (pre-dose) and 8- hours post-dose and Day 5: 0- (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8-, 12-, 24-, 36-, 48-, and 72- hours post-dose: Part 3, Day 1: - (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8-, 16- hours post-dose, Day 5: 0- (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8-, 10-, 12-, 16-, 24-hours post-dose
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Secondary outcome [2]
436843
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Part 1, 2 and 3- Ae: Amount of SEP-786 Excreted in Urine
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Assessment method [2]
436843
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Amount of SEP-786 excreted in urine in percent of dose will be assessed in microgram by high-performance liquid chromatography-mass spectrometry (HPLC-MS/MS).
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Timepoint [2]
436843
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Part 1: Days 1, 2, 3 and 4 post-dose; Part 2 and 3: Days 5, 6, 7 and 8 post-dose
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Secondary outcome [3]
436844
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Part 1, 2 and 3- Rmax: Rate of SEP-786 Excretion in Urine
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Assessment method [3]
436844
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Maximum rate of urinary extraction (Rmax) of SEP-786 will be assessed in microgram/hour.
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Timepoint [3]
436844
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Part 1: Days 1, 2, 3 and 4 post-dose; Part 2 and 3: Days 5, 6, 7 and 8 post-dose
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Secondary outcome [4]
436845
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Part 1, 2 and 3- CLR: Mean Renal Clearance
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Assessment method [4]
436845
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Renal clearance refers to the volume of plasma cleared of SEP-786 per unit of time by the kidneys. CLR will be assessed in liter/hour.
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Timepoint [4]
436845
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Part 1: Days 1, 2, 3 and 4 post-dose; Part 2 and 3: Days 5, 6, 7 and 8 post-dose
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Secondary outcome [5]
436847
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Parts 1, 2 and 3- Emax: Maximum Effect of SEP-786 on Albumin-adjusted Serum Calcium following Single and Multiple Doses
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Assessment method [5]
436847
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Serum chemistry will be used to determine change from baseline and absolute albumin adjusted serum calcium concentration in mmol/L post-dose using observed data.
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Timepoint [5]
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Part 1, Day 1: 0- (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8-, 10-, 12-, 16-, 24-, 48-, and 72- hours post-dose; Part 2, Day 1: 0- (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8-, 12- hours post-dose, Day 2 to 4: 0- (pre-dose) and 8- hours post-dose and Day 5: 0- (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8-, 12-, 24-, 36-, 48-, and 72- hours post-dose: Part 3, Day 1: - (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8- hours post-dose, Day 5: 0- (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8-, 10-, 12-, 16-, 24-hours post-dose
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Secondary outcome [6]
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Parts 1, 2 and 3- TEmax- Time to Emax for Albumin-adjusted Serum Calcium Following Single and Multiple Doses
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Assessment method [6]
436848
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Time to reach Emax in hours will be determined from observed data.
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Timepoint [6]
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Part 1, Day 1: 0- (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8-, 10-, 12-, 16-, 24-, 48-, and 72- hours post-dose; Part 2, Day 1: 0- (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8-, 12- hours post-dose, Day 2 to 4: 0- (pre-dose) and 8- hours post-dose and Day 5: 0- (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8-, 12-, 24-, 36-, 48-, and 72- hours post-dose: Part 3, Day 1: - (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8- hours post-dose, Day 5: 0- (pre-dose), 0.5-, 1-, 2-, 3-, 4-, 6-, 8-, 10-, 12-, 16-, 24-hours post-dose
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Eligibility
Key inclusion criteria
1. Are 24 through 55 years of age, inclusive, at the time of signing the informed consent
2. Are overtly healthy, as determined by medical evaluation, including medical history, physical examinations, laboratory profiles, vital signs, and 12 lead ECGs
3. Have clinical laboratory test values within the normal range, unless assessed by the investigator or designee as a clinically nonsignificant value, with repeat laboratory tests permitted if necessary to make decisions
4. Have a body weight within the range of greater than or equal to (>=) 50 kilogram (kg) and less than or equal to (<=) 90 kg and body mass index (BMI) within the range of >=18.5 to <=27.0 kilogram per square meter (kg/m^2)
5. Have an estimated glomerular filtration rate (eGFR) >=90 milliliter per minute (mL/min)
Note: eGFR is estimated by the chronic kidney disease epidemiology collaboration (CKD EPI) equation
6. Have a QT interval corrected by Fridericia’s method (QTcF) <=450 millisecond (ms) for assigned male at birth (AMAB) participants and <=470 ms for assigned female at birth (AFAB) participants at screening
7. Have inorganic phosphorus and/or serum calcium (albumin corrected) within normal limits at screening and Day -2, unless assessed by the investigator as a clinically insignificant value
8. Are willing and able to abstain from drug, alcohol, and tobacco from Day -2 until discharge from the clinical research unit (CRU)
9. Have negative urine drug and breath alcohol results at screening and Day -2
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Minimum age
24
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Have a history or presence of any of the following:
a. Malignant disease, other than basal cell epithelioma/carcinoma or completely resected squamous skin cancer with no recurrence for 12 months
b. Diabetes mellitus
Note: a history of gestational diabetes that is fully resolved is permitted.
c. Hyperparathyroidism, hypoparathyroidism, hypercalcemia, hypercalciuria, kidney stones, familial benign hypocalciuric hypercalcemia, osteomalacia, Paget’s disease, osteoporosis, or any type of metabolic bone disease or radiation therapy to the skeleton
d. Cardiac dysfunction, including abnormal echocardiogram left ventricular ejection fraction (LVEF) <50%, congestive heart failure, long QT syndrome, valvular heart disease except clinically insignificant mitral valve prolapse, hypertrophic cardiomyopathy, or cardiovascular disease
e. Cerebrovascular disease
f. Thromboembolic events or ischemic heart disease
g. Alcoholism or drug abuse within the past 1 year
Note: Alcohol abuse is considered >14 standard drinks/week in AFAB potential participants and >21 standard drinks/week in AMAB potential participants.
h. Stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
i. Clinically significant medical or psychiatric condition or disease in the opinion of the principal investigator or designee
j. Hepatitis B (defined as HBsAg reactive) or hepatitis C (defined as HCV antibody–positive) at screening
k. Human immunodeficiency virus (HIV) positive status (participants to be screened for HIV or provide a recent negative test)
2. Have an acute disease state (eg, nausea, vomiting, fever, diarrhea) within 7 days of the first dose of study intervention
3. Have a positive COVID 19 polymerase chain reaction (PCR) test at admission
4. Are unable to refrain from using or anticipate the use of any drug or medical device, including prescription and over the counter (OTC) medications, nutritional or dietary supplements, recreational drugs, herbal preparations, or vitamins, from Day -7 until follow up visit, or as specified below:
a. From Day -28 for significant inhibitors or inducers of CYP enzymes and/or P gp, including St. John’s wort, to discharge from CRU
b. From Day -42 for PPIs, supplements containing calcium (Ca) or magnesium (Mg) (including Tums®), and H2 antagonists until discharge from CRU
Exceptions:
a. Acetaminophen, which may be used at doses of 1 gram or less per day until 24 hours prior to check in
b. OTC nonsteroidal anti inflammatory drug (NSAIDs), which may be used until 24 hours prior to check in
c. OCPs or an intrauterine device (IUD) or intrauterine hormone releasing system (IUS)
d. Any drug approved by the medical monitor
5. Have participated in another clinical study within 28 days prior to the first dose of study drug or at least 5.5 half lives, based on the t1/2 for the investigational drug, whichever is longer. The 28 day window is derived from date of the previous study’s last scheduled blood collection or dosing, whichever was later, to Day 1 of the current study.
6. Have clinically significant abnormalities on clinical laboratory results (including hematology, chemistry, and urinalysis) at screening and Day -2
7. Have evidence of endocrine alterations of calcium/phosphate/PTH homeostasis at screening
8. Have donated blood within 7 days of the first dose of study intervention or have had significant (ie, >=500 mL) blood loss within 8 weeks of the first dose of study intervention
9. Have used tobacco within 60 days of screening at a rate of >5 units (cigarettes or vaping equivalents)/week
10. Have consumed alcohol within 24 hours of check in
11. Have a known hypersensitivity to the components of the study intervention
12. Are likely to be noncompliant with respect to study conduct
13. Are mentally or legally incapacitated or have significant emotional problems at the time of the screening visit or expect to have any during the conduct of the study
14. Have any other reason that, in the opinion of the investigator or designee, would prevent the participant from completing participation or following the study schedule
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed and involves contacting the holder of the allocation schedule (randomization list), who is an unblinded pharmacist at the site.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
5/08/2024
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Actual
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Date of last participant enrolment
Anticipated
9/05/2025
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Actual
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Date of last data collection
Anticipated
23/05/2025
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Septerna, Inc.
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Address [1]
316795
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Septerna, Inc.
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Address
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Country
United States of America
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Secondary sponsor category [1]
319017
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None
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Name [1]
319017
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Address [1]
319017
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Country [1]
319017
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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24/06/2024
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Approval date [1]
315564
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Ethics approval number [1]
315564
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Summary
Brief summary
The main aim of the study is to evaluate the safety, PK, and PD effects of SEP 786 in healthy participants. The results of this study will help inform the dosing and frequency of dosing in participants with hypoparathyroidism, which is the anticipated main therapeutic use for SEP-786.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Chirstina Chang
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Address
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Nucleus Network Pty Ltd. Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, Victoria, 3004
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Country
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Australia
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Phone
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+61 03 8593 9801
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Nucleus Network Melbourne
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Address
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Nucleus Network Melbourne, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, Victoria, 3004
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Country
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Australia
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Phone
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+61 1800 243 733
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Nucleus Network Melbourne
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Address
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Nucleus Network Melbourne, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, Victoria, 3004
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Country
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Australia
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Phone
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+61 1800 243 733
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Fax
135092
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF