A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RTA 1701 in Healthy Adults

Biogen1 site in 1 country90 target enrollmentJune 20, 2018

ConditionsHealthy

InterventionsPlacebo oral capsule RTA 1701 capsules

DrugsPlacebo oral capsule RTA 1701 capsules

Overview

Phase: Phase 1
Intervention: Placebo oral capsule
Conditions: Healthy
Sponsor: Biogen
Enrollment: 90
Locations: 1
Primary Endpoint: Incidence of treatment-emergent adverse events
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Detailed Description

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Registry

clinicaltrials.gov

Start Date

June 20, 2018

End Date

June 28, 2019

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biogen

Responsible Party

Sponsor

Eligibility Criteria

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;

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;

Arms & Interventions

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

Intervention: Placebo oral capsule

Single Dose of RTA 1701 or Placebo

Intervention: RTA 1701 capsules

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

Intervention: Placebo oral capsule