NCT02108106

A Phase I Study of AG-348 in Healthy Volunteers

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Safety, Pharmacokinetic and Pharmacodynamic Study of Orally Administered AG-348 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Agios Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	AG-348	A range of doses of AG-348 will be tested based on assessment of safety and tolerability.
DRUG	Placebo

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-04-09
• Last updated: 2014-10-22

Locations

1 site across 1 country: United States