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NCT02108106 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of AG-348 in Healthy Volunteers
A Phase 1 study, sponsored by Agios Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT02108106: Completed Phase 1 study, sponsored by Agios Pharmaceuticals.
NCT02108106 is a Phase 1 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02108106, a Phase 1 study, has completed, sponsored by Agios Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is a dose escalation study that will be conducted in healthy volunteers. Multiple cohorts of volunteers will receive ascending oral doses of AG-348 to evaluate the safety and tolerability of a single oral dose of AG-348, the pharmacokinetics (PK) of a single dose of AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the blood.
Primary Outcome
Incidence of adverse events and descriptive statistics for safety laboratory parameters, physical exam findings, vital signs and ECGs.
Interventions
- DRUG Placebo
- DRUG AG-348
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT02108106 record still lists
NCT02108106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02108106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02108106 about?
NCT02108106 is a clinical study titled "A Phase I Study of AG-348 in Healthy Volunteers". This is a dose escalation study that will be conducted in healthy volunteers. Multiple cohorts of volunteers will receive ascending oral doses of AG-348 to evaluate the safety and tolerability of a single oral dose of AG-348, the pharmacokinetics (PK) of a single dose of AG-348, and the pharmacodyna...
What is the current status of trial NCT02108106?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2014-03. Estimated completion is 2014-08.
What interventions are being tested in trial NCT02108106?
The interventions under investigation include: Placebo (DRUG), AG-348 (DRUG).
Who is sponsoring clinical trial NCT02108106?
This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02108106's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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