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

NCT03397329 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-01-12

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Agios Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Affairs, Agios Pharmaceuticals, Inc · Agios Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-03
Primary Completion
2017-11-13
Completion
2017-11-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03397329 on ClinicalTrials.gov