Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-02-02 @ 4:12 AM
Study NCT ID:
NCT02149966
Status:
COMPLETED
Last Update Posted:
2014-11-10
First Post:
2014-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of AG-348 in Healthy Volunteers
Sponsor:
Agios Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Pharmacokinetic, and Pharmacodynamic Study of Orally Administered AG-348 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AG-348MAD
Brief Summary:
This is a dose escalation study that will be conducted in healthy volunteers. Multiple cohorts of volunteers will receive ascending (increasingly higher) oral doses of AG-348 daily for 14 days to evaluate the safety and tolerability of multiple oral doses of AG-348, the pharmacokinetics (PK) of multiple doses of AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the blood.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: