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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05070702




Registration number
NCT05070702
Ethics application status
Date submitted
13/09/2021
Date registered
7/10/2021

Titles & IDs
Public title
First in Human Study of CT-1500 in Healthy Participants
Scientific title
First in Human Study in Healthy Subjects to Investigate the Safety, Tolerability and Pharmacokinetics of Single Ascending and Repeat Doses of CT-1500
Secondary ID [1] 0 0
CT-1500-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CT-1500
Treatment: Drugs - Placebo

Experimental: CT-1500 Active (SAD) - 6 out of 8 participants per cohort (up to 5 cohorts) will be randomized to receive a single oral dose of CT-1500 between 5 mg and 120 mg

Placebo comparator: Placebo (SAD) - 2 out of 8 participants per cohort (up to 5 cohorts) will be randomized to receive a single oral dose of matching placebo

Experimental: CT-1500 Active (MAD) - 6 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 7 daily oral doses of CT-1500 between 5 and 45 mg

Placebo comparator: Placebo (MAD) - 2 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 7 daily oral doses of matching placebo


Treatment: Drugs: CT-1500
Hard Capsule

Treatment: Drugs: Placebo
Hard Capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events (AEs) and Serious Adverse Events (SAEs) during the SAD part of the study
Timepoint [1] 0 0
Initiation of dosing through 7 days post dose
Primary outcome [2] 0 0
Adverse Events and Serious Adverse Events during the MAD part of the study
Timepoint [2] 0 0
Initiation of dosing through 14 days post dose
Primary outcome [3] 0 0
Tolerability of CT-1500 as defined by change from baseline in Heart Rate (SAD)
Timepoint [3] 0 0
Initiation of dosing through 7 days post dose
Primary outcome [4] 0 0
Tolerability of CT-1500 as defined by change from baseline in Heart Rate (MAD)
Timepoint [4] 0 0
Initiation of dosing through 14 days post dose
Primary outcome [5] 0 0
Tolerability of CT-1500 as defined by change from baseline in Respiratory Rate (SAD)
Timepoint [5] 0 0
Initiation of dosing through 7 days post dose
Primary outcome [6] 0 0
Tolerability of CT-1500 as defined by change from baseline in Respiratory Rate (MAD)
Timepoint [6] 0 0
Initiation of dosing through 14 days post dose
Primary outcome [7] 0 0
Tolerability of CT-1500 as defined by change from baseline in Electrocardiogram Assessment (SAD)
Timepoint [7] 0 0
Initiation of dosing through 7 days post dose
Primary outcome [8] 0 0
Tolerability of CT-1500 as defined by change from baseline in Electrocardiogram assessment (MAD)
Timepoint [8] 0 0
Initiation of dosing through 14 days post dose
Primary outcome [9] 0 0
Tolerability of CT-1500 as defined by change from baseline in Spirometry assessment (SAD)
Timepoint [9] 0 0
Initiation of dosing through 7 days post dose
Primary outcome [10] 0 0
Tolerability of CT-1500 as defined by change from baseline in Spirometry assessment (MAD)
Timepoint [10] 0 0
Initiation of dosing through 14 days post dose
Primary outcome [11] 0 0
Change in Renal function from baseline (SAD)
Timepoint [11] 0 0
Initiation of dosing through 24 hours post dose
Primary outcome [12] 0 0
Change in Renal function from baseline (MAD)
Timepoint [12] 0 0
Initiation of dosing on Day 1 through 24 hours and initiation of dosing on Day 7 through 24 hours
Secondary outcome [1] 0 0
Pharmacokinetic parameter: AUC-last (SAD)
Timepoint [1] 0 0
Baseline (predose) through 48 hours post dose
Secondary outcome [2] 0 0
Pharmacokinetic parameter: AUC-last (SAD)
Timepoint [2] 0 0
Baseline (predose) through 48 hours post dose
Secondary outcome [3] 0 0
Pharmacokinetic parameter: AUC-last (SAD)
Timepoint [3] 0 0
Baseline (predose) through 48 hours post dose
Secondary outcome [4] 0 0
Pharmacokinetic parameter: AUC-last (MAD)
Timepoint [4] 0 0
Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Secondary outcome [5] 0 0
Pharmacokinetic parameter: AUC-last (MAD)
Timepoint [5] 0 0
Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Secondary outcome [6] 0 0
Pharmacokinetic parameter: AUC-last (MAD)
Timepoint [6] 0 0
Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Secondary outcome [7] 0 0
Pharmacokinetic parameter: AUC-inf (SAD)
Timepoint [7] 0 0
Baseline (predose) through 48 hours post dose
Secondary outcome [8] 0 0
Pharmacokinetic parameter: AUC-inf (MAD)
Timepoint [8] 0 0
Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Secondary outcome [9] 0 0
Pharmacokinetic parameter: Cmax (SAD)
Timepoint [9] 0 0
Baseline (predose) through 48 hours post dose
Secondary outcome [10] 0 0
Pharmacokinetic parameter: Cmax (SAD)
Timepoint [10] 0 0
Baseline (predose) through 48 hours post dose
Secondary outcome [11] 0 0
Pharmacokinetic parameter: Cmax (SAD)
Timepoint [11] 0 0
Baseline (predose) through 48 hours post dose
Secondary outcome [12] 0 0
Pharmacokinetic parameter: Cmax (MAD)
Timepoint [12] 0 0
Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Secondary outcome [13] 0 0
Pharmacokinetic parameter: Cmax (MAD)
Timepoint [13] 0 0
Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Secondary outcome [14] 0 0
Pharmacokinetic parameter: Cmax (MAD)
Timepoint [14] 0 0
Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Secondary outcome [15] 0 0
Pharmacokinetic parameter: Tmax (SAD)
Timepoint [15] 0 0
Baseline (predose) through 48 hours post dose
Secondary outcome [16] 0 0
Pharmacokinetic parameter: Tmax (SAD)
Timepoint [16] 0 0
Baseline (predose) through 48 hours post dose
Secondary outcome [17] 0 0
Pharmacokinetic parameter: Tmax (SAD)
Timepoint [17] 0 0
Baseline (predose) through 48 hours post dose
Secondary outcome [18] 0 0
Pharmacokinetic parameter: Tmax (MAD)
Timepoint [18] 0 0
Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Secondary outcome [19] 0 0
Pharmacokinetic parameter: Tmax (MAD)
Timepoint [19] 0 0
Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Secondary outcome [20] 0 0
Pharmacokinetic parameter: Tmax (MAD)
Timepoint [20] 0 0
Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours

Eligibility
Key inclusion criteria
* Generally healthy with the exception of those medical conditions allowed per the study criteria
* Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures
* Body Mass Index (BMI) of 18.5 to 32 kg/m2 and weight >48 kg
* Systolic Blood Pressure (BP) of 90-140 mmHg, Diastolic BP of 40-90 mmHg and Heart Rate between 40 and 100 bpm
* Forced Expiratory Volume in one second (FEV1) > 85% predicted
* Clinical laboratory results at screening and Day -1 to be within normal limits unless deemed as not clinically significant by the investigator
* Willing to consume bovine containing products (investigational product capsules are bovine gelatin in origin);
* Agree not to donate blood or plasma products for at least 30 days after the end of study (EOS) visit
* Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day -1, must not be breastfeeding, lactating or planning a pregnancy and must use an acceptable form of contraception during the treatment period and for 32 days after the last dose
* Male participants with a female partner of childbearing potential must agree to use an acceptable form of contraception during the treatment period and for 92 days after the last dose
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Significant current or historical disease, including intercurrent illness in the 4 weeks prior to screening
* Current or historical diagnosis of sleep disorders
* Hepatic disorders other than benign unconjugated hyperbilirubinaemia
* History of moderate or severe psychiatric illness
* History of severe allergy or anaphylaxis to any drug, food, toxin or other exposure
* Heavy caffeine drinker in the last 3 months. If subjects are willing to reduce their caffeine intake for 14 days prior to first dose and for the duration of the study, they can participate
* Hypersensitivity to CT-1500 or any of the inert excipients in the capsule formulation
* Positive hepatitis B surface antigen (HBsAg), positive hepatitis C antibody (HCV) or positive human immunodeficiency virus (HIV) test
* Treatment with an investigational drug within 30 days or less than 5 half-lives (whichever is longer) prior to screening
* Use of prescription medication within 14 days prior to investigational product administration until the end of study visit, with the exception of oral contraceptives.
* Use of over-the-counter medication and supplements for 7 days prior to investigation product administration until the end of study visit. Exceptions at the discretion of the investigator.
* Receipt of a Coronavirus disease 2019 (COVID-19) vaccine within 14 days prior to investigational product administration or a planned second dose of a COVID-19 vaccine during study participation
* Use of tobacco or nicotine-containing products in excess of 2 cigarettes per day within 1 month prior to screening
* Major surgery in the 6 months preceeding screening or planned surgery during the study
* Donated blood or blood products or had a substantial loss of blood with 3 months prior to screening
* A history of drug abuse or addiction
* A history of alcoholism or consumption of more than 3 alcoholic drinks per day or consumption of alcohol within 48 hours prior to first dose
* Unable to abstain from grapefruit-containing foods or beverages or Seville orange-containing foods or beverages from 48 hours prior to investigational product administration until completion of the confinement period;
* Unable to avoid heavy exercise (eg, marathon runners, weight-lifters) from 48 hours prior to investigational product administration until completion of the confinement period

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/07/2022
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Circadian Therapeutics Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Neuroscience Trials Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philip Ryan, Dr
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The Sponsor will consider requests from appropriately qualified researchers for study information and participant data upon a formal request to [email protected].

Supporting document/s available: Study protocol, Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05070702