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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03579030




Registration number
NCT03579030
Ethics application status
Date submitted
25/05/2018
Date registered
6/07/2018
Date last updated
2/02/2024

Titles & IDs
Public title
Safety and PK/PD of RTA 1701 in Healthy Adults
Scientific title
A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RTA 1701 in Healthy Adults
Secondary ID [1] 0 0
1701-C-1802
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 - Placebo oral capsule
Treatment: Drugs - RTA 1701 capsules

Experimental: Single Dose of RTA 1701 or Placebo - RTA 1701 capsules or placebo taken orally in a single dose.
Group 1: RTA 1701 10 mg or matching placebo Group 2: RTA 1701 = 20 mg or matching placebo Group 3: RTA 1701 = 40 mg or matching placebo Group 4: RTA 1701 = 80 mg or matching placebo Group 5: RTA 1701 = 160 mg or matching placebo Group 6: RTA 1701 = 320 mg or matching placebo Group 7: RTA 1701 = 640 mg or matching placebo

Experimental: Multiple Dose of RTA 1701 or Placebo - RTA 1701 capsules, Dose TBD mg or placebo taken orally once daily for 14 weeks.
Group 8: RTA 1701 =40 mg or matching placebo Group 9: RTA 1701 =160 mg or matching placebo Group 10: RTA 1701 =640 mg or matching placebo


Treatment: Drugs: Placebo oral capsule
Placebo capsule matched to an RTA 1701 capsule

Treatment: Drugs: RTA 1701 capsules
Capsule containing RTA 1701, multiple dosages
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events
Timepoint [1] 0 0
3 weeks

Eligibility
Key inclusion criteria
- Male or female and age is between 18 and 55 years, inclusive;

- Female participants of childbearing potential must:

- Not be pregnant, or lactating, or planning a pregnancy, and

- Be willing to use contraception (hormonal contraceptives, diaphragm, or intrauterine
contraception) or abstain from sexual activity (if this is the preferred lifestyle for
the participant) for the duration of the study (from initial study drug administration
through 90 days after administration of the last dose of study drug);

- Females must have negative results for pregnancy tests performed:

- At screening based on a serum sample, and

- Prior to dosing on Day -1 based on a urine sample;

- If male, participant must be surgically sterile or practice specified methods of
contraception from initial study drug administration through 90 days after
administration of the last dose of study drug. Male participants must also use a
condom during sex to protect male or female partners of male participants from
exposure to study drug. In addition to use of a condom, male participants with female
partners must also use one of the following acceptable forms of contraception:

- Have had a vasectomy (at least 6 months earlier);

- Partner use of hormonal contraceptives (oral, parenteral, vaginal, or transdermal) for
at least 3 months prior to study drug administration;

- Partner use of an intrauterine device;

- Complete abstinence from sexual intercourse (if this is the preferred lifestyle for
the participant);

- If male, participant agrees to abstain from sperm donation from initial study drug
administration through 90 days after administration of the last dose of study drug;

- Body Mass Index (BMI) is = 18.0 to = 31.0 kg/m2, inclusive;

- A condition of general good health, based upon the results of a medical history,
physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram
(ECG), as judged by the investigator;

- Must voluntarily sign and date each informed consent, approved by a Human Research
Ethics Committee (HREC), prior to the initiation of any screening or study-specific
procedures.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of clinically significant drug allergies, including allergies to any of the
components of the investigational product and/or clinically significant food allergies
as determined by the investigator;

- Presence or history of any significant cardiovascular, gastrointestinal, hepatic,
renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or
psychiatric disease, as determined by the investigator;

- Presence of any other condition (including surgery) known to interfere with the
absorption, distribution, metabolism, or excretion of medicines;

- Requirement for any over-the-counter and/or prescription medication, vitamins, and/or
herbal supplements on an ongoing basis;

- Use of any OTC medications (over-the-counter), including herbal products, within 7
days prior to Day 1, other than limited paracetamol use (= 2 g/day) or oral
contraceptive pill. Use of any prescription medication within 14 days or 5 half-lives
(whichever is longer), prior to study drug administration, unless in the opinion of
the Principal Investigator and/or Medical Monitor the medication will not compromise
participant safety or interfere with study procedures or data validity;

- Recent (6-month) history of drug or alcohol abuse;

- Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus
antibody (HCV Ab), or HIV antibodies (HIV Ab) at screening;

- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt
of a transfusion of any blood product within 8 weeks prior to study drug
administration;

- Receipt of any investigational product within a time period equal to 10 half-lives of
the product, if known, or a minimum of 30 days prior to study drug administration;

- Positive screen results for drugs of abuse, alcohol, or cotinine at screening or Day
-1;

- Consumption of alcohol within 72 hours prior to study drug administration;

- Consumption of grapefruit, grapefruit products, star fruit, star fruit products, or
Seville oranges within the 72-hour period prior to study drug administration;

- Use of tobacco or nicotine-containing products within the 6-month period preceding
study drug administration;

- Current enrollment in another clinical study;

- Screening laboratory analyses that show any of the following abnormal laboratory
results:

- Alanine transaminase (ALT) level above 1.5 times the upper limit of normal (ULN);

- Aspartate transaminase (AST) level above 1.5 times the ULN;

- Any other laboratory results that are outside of the laboratory normal reference range
and considered clinically significant by the investigator;

- Clinically-significant abnormal ECG; ECG with QTc using Fridericia's correction
formula (QTcF) > 450 msec (for males) or >460 msec (for females) is exclusionary;

- Consideration by the investigator, for any reason, that the participant is an
unsuitable candidate to receive RTA 1701.

Study design
Purpose of the study
Treatment
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
Parallel
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
20/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/06/2019
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Reata, a wholly owned subsidiary of Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This first-in-human, Phase 1, single-center study will evaluate single ascending doses (SAD)
and multiple ascending doses (MAD) of RTA 1701 conducted in 2 parts. Part 1 (SAD) of this
study will be conducted in approximately 56 healthy participants in up to 7 groups. Each
group will consist of up to 8 participants who will be randomized in a 3:1 ratio to receive a
single dose of RTA 1701 or placebo, respectively. Safety, tolerability, and available
pharmacokinetics in each group will be assessed by the Safety Monitoring Committee prior to
dose escalation.

Part 2 (MAD) of this study will be conducted in approximately 30 healthy participants in up
to 3 groups and will commence after safety data for the highest dose in the SAD phase has
been evaluated. Each group will consist of up to 10 participants who will be randomized in a
4:1 ratio to receive 14 daily doses of RTA 1701 or placebo, respectively. Safety,
tolerability, and available pharmacokinetics will be assessed in each dosing group prior to
dose escalation
Trial website
https://clinicaltrials.gov/ct2/show/NCT03579030
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03579030