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NCT03703505 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of AG-348 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348
A Phase 1 study, sponsored by Agios Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT03703505 is a Phase 1 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 8 participants.
The verdict
NCT03703505, a Phase 1 study, has completed, sponsored by Agios Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study will assess absorption, distribution, metabolism, excretion and absolute bioavailability of AG-348 in healthy male participants. Potential participants will be screened within 29 days prior to dose administration to determine eligibility. Eligible Participants will be admitted into the Clinical Research Unit (CRU) one day prior to administration of AG-348 and will be confined to the CRU until at least Day 8. If participants are not eligible for discharge on Day 8, they may remain in the CRU up to Day 11. Radiolabelled analytes of AG-348 will be administered in a single oral and intravenous (IV) dose on Day 1. Participants will be required to fast pre-dose, remain in a supine position for 1 hour post-dose and avoid water for 2 hours post-dose.
Interventions
- DRUG AG-348
- DRUG [13C6]AG-348
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-05-24 |
| Est. Completion | 2018-06-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03703505
The ClinicalTrials.gov registry entry for NCT03703505 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 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 2 interventions - of which AG-348 is the first listed.
NCT03703505 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03703505 about?
NCT03703505 is a clinical study titled "A Study to Evaluate the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of AG-348 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348". This study will assess absorption, distribution, metabolism, excretion and absolute bioavailability of AG-348 in healthy male participants. Potential participants will be screened within 29 days prior to dose administration to determine eligibility. Eligible Participants will be admitted into the Cl...
What is the current status of trial NCT03703505?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2018-05-24. Estimated completion is 2018-06-04.
What interventions are being tested in trial NCT03703505?
The interventions under investigation include: AG-348 (DRUG), [13C6]AG-348 (DRUG).
Who is sponsoring clinical trial NCT03703505?
This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.
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