NCT02149966

A Phase I Study of AG-348 in Healthy Volunteers

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
• 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 (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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	AG-348	A range of doses of AG-348 will be tested based on the assessment of safety and tolerability. AG-348 will be administered by mouth (orally) each day for a period of 14 days.
DRUG	Placebo	Placebo will be administered by mouth (orally) each day for a period of 14 days.

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-05-29
• Last updated: 2014-11-10

Locations

1 site across 1 country: United States