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NCT02666963 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
NCT02666963 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 78 participants.
The verdict
NCT02666963, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
Study Summary
This study will assess the safety, tolerability, and pharmacokinetic profile of RTA 901 following escalating single and multiple oral doses of RTA 901 in healthy adult subjects. This first-in-human, Phase 1, single-center study consists of single ascending doses (SAD) and multiple ascending doses (MAD) conducted in 2 parts. Part 1 (SAD) of this study will be conducted in approximately 56 healthy subjects in up to 7 groups. Each group will consist of up to 8 subjects who will be randomized in a 3:1 ratio to receive a single dose of RTA 901 or placebo, respectively. Safety, tolerability, and available pharmacokinetics through Day 4 will be assessed in each group prior to dose escalation. Part 2 (MAD) of this study will be conducted in approximately 30 healthy subjects in up to 3 groups. Each group will consist of up to 10 subjects who will be randomized in a 4:1 ratio to receive 14 daily doses of RTA 901 or placebo, respectively. Safety, tolerability, and available pharmacokinetics through Day 17 will be assessed in each dosing group prior to dose escalation.
Interventions
- DRUG Placebo
- DRUG RTA 901 Capsules, 10 or 40 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2017-01-01 |
| Est. Completion | 2017-07-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02666963
The ClinicalTrials.gov registry entry for NCT02666963 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02666963 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02666963 about?
NCT02666963 is a clinical study titled "A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults". This study will assess the safety, tolerability, and pharmacokinetic profile of RTA 901 following escalating single and multiple oral doses of RTA 901 in healthy adult subjects. This first-in-human, Phase 1, single-center study consists of single ascending doses (SAD) and multiple ascending doses (...
What is the current status of trial NCT02666963?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2017-01-01. Estimated completion is 2017-07-23.
What interventions are being tested in trial NCT02666963?
The interventions under investigation include: Placebo (DRUG), RTA 901 Capsules, 10 or 40 mg (DRUG).
Who is sponsoring clinical trial NCT02666963?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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