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NCT03250598 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin
A Phase 1 study, sponsored by Agios Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT03250598 is a Phase 1 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 60 participants.
The verdict
NCT03250598, 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, safety, and effect on QTc interval of AG-348 in healthy, adult Japanese and Non-Asian subjects. The study plans to evaluate 3 cohorts of a single oral dose of AG-348 in Japanese and Non-Asian subjects. Pharmacokinetic sampling will take place serially at specified times during conduct of the study.
Interventions
- DRUG AG-348
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-08-09 |
| Est. Completion | 2017-10-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03250598
The ClinicalTrials.gov registry entry for NCT03250598 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 AG-348 is the first listed.
NCT03250598 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03250598 about?
NCT03250598 is a clinical study titled "Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin". The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics, safety, and effect on QTc interval of AG-348 in healthy, adult Japanese and Non-Asian subjects. The study plans to evaluate 3 cohorts of a single oral dose of AG-348 in Japanese and Non-Asian subjects. Ph...
What is the current status of trial NCT03250598?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2017-08-09. Estimated completion is 2017-10-09.
What interventions are being tested in trial NCT03250598?
The interventions under investigation include: AG-348 (DRUG).
Who is sponsoring clinical trial NCT03250598?
This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.
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