NCT04128787

A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881

A Phase 1, Open-Label Study to Compare the Relative Bioavailability of Two AG-881 Formulations and to Evaluate the Effect of Food and Multiple-Dose Omeprazole on the Pharmacokinetics of a Single Dose of AG-881 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Agios Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the single-dose pharmacokinetics (PK) of two formulations (Formulation 1 and Formulation 2) of AG-881 and to examine the effect of food and multiple-dose omeprazole on the single-dose PK of AG-881 Formulation 2 in healthy adult participants. This study will also assess the safety and tolerability of single-dose AG-881 (Formulation 1 and 2) alone and of AG-881 Formulation 2 when administered with and without food and when coadministered with omeprazole in healthy adult subjects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	AG881 Formulation 1	AG881 uncoated tablets
DRUG	AG881 Formulation 2	AG881 film-coated tablets
DRUG	Omeprazole	Omeprazole capsules

Timeline

• Start date: 2019-09-30
• Primary completion: 2019-12-18
• Completion: 2019-12-18
• First posted: 2019-10-16
• Last updated: 2021-07-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study