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NCT03071770 · ClinicalTrials.gov registry record · Phase 1
Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects
A Phase 1 study, sponsored by Agios Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT03071770 is a Phase 1 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 60 participants.
The verdict
NCT03071770, a Phase 1 study, has completed, sponsored by Agios Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics and safety of ivosidenib (AG-120) in healthy, adult male Japanese and Caucasian subjects. The study plans to evaluate 3 cohorts of a single oral dose of ivosidenib (AG-120) in Japanese and Caucasian subjects. Pharmacokinetic sampling will take place serially through-out the duration of subject participation.
Interventions
- DRUG ivosidenib (AG-120)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-03-31 |
| Est. Completion | 2017-09-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03071770
The ClinicalTrials.gov registry entry for NCT03071770 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Agios Pharmaceuticals, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ivosidenib (AG-120) is the first listed.
NCT03071770 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03071770 about?
NCT03071770 is a clinical study titled "Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects". The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics and safety of ivosidenib (AG-120) in healthy, adult male Japanese and Caucasian subjects. The study plans to evaluate 3 cohorts of a single oral dose of ivosidenib (AG-120) in Japanese and Caucasian subjec...
What is the current status of trial NCT03071770?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2017-03-31. Estimated completion is 2017-09-06.
What interventions are being tested in trial NCT03071770?
The interventions under investigation include: ivosidenib (AG-120) (DRUG).
Who is sponsoring clinical trial NCT03071770?
This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.
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