NCT03397329

Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults

A Phase 1, Randomized, Open-Label, Two-Period Crossover Study Evaluating the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations After Single-Dose Administration in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Agios Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this Phase 1, randomized, open-label, two-period crossover study is to characterize and compare the pharmacokinetic (PK) profiles and evaluate the safety of the AG-348 tablet and capsule formulations after single-dose administration in healthy adult subjects. Pharmacokinetic sampling will take place serially at specified times during conduct of the study.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	AG-348 Sequence A	1. Treatment Period 1 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules) 2. Washout Period 7 days 3. Treatment Period 2 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet)
DRUG	AG-348 Sequence B	1. Treatment Period 1 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet) 2. Washout Period 7 days 3. Treatment Period 2 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules)

Timeline

• Start date: 2017-10-03
• Primary completion: 2017-11-13
• Completion: 2017-11-13
• First posted: 2018-01-12
• Last updated: 2018-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study