NCT03991312

Study to Evaluate the Effect of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of Mitapivat Sulfate (AG-348) in Healthy Adult Participants

A Two-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of Mitapivat Sulfate (AG-348) in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Agios Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Part 1 of this study will determine the effect of multiple-dose itraconazole, a strong cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) inhibitor, on the single-dose pharmacokinetic(s) (PK) of mitapivat sulfate in healthy adult participants. Part 2 of this study will determine the effect of multiple-dose rifampin, a strong CYP3A4 and P-gp inducer, on the single-dose pharmacokinetic(s) (PK) of mitapivat sulfate in healthy adult participants.

Detailed description

This study consists of 2 periods and 2 parts. Participants will be placed in Part 1 or Part 2, and cannot participate in both: Part 1, Period 1 includes a screening period up to 28 days prior to dosing and treatment on Day 1. Part 1, Period 2 includes a treatment period from Day 1 to Day 9 and a possible follow-up, up to 28 days after the last dose of study drug. Part 2, Period 1 includes a screening period up to 28 days prior to dosing and treatment on Day 1. Part 2, Period 2 includes a treatment period from Day 1 to Day 12 and a possible follow-up, up to 28 days after the last dose of study drug.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	itraconazole	Participants will receive an oral solution as described in the arm description.
DRUG	rifampin	Participants will receive oral capsule(s) as described in the arm description.
DRUG	mitapivat sulfate	Participants will receive an oral tablet as described in the arm description.

Timeline

• Start date: 2019-06-20
• Primary completion: 2019-08-14
• Completion: 2019-09-10
• First posted: 2019-06-19
• Last updated: 2019-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study