NCT05868356

A PK Study to Assess the Drug-drug Interaction of a Strong CYP2C8 Inhibitor on Adagrasib

A Phase 1, Open-label, Multiple-dose, One-sequence Crossover Study to Investigate the Effect of Repeated Oral Doses of a Strong CYP2C8 Inhibitor on the Steady-state Pharmacokinetics of Adagrasib in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Mirati Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Open-label, Multiple-dose, One-sequence Crossover Study to Investigate the Effect of Repeated Oral Doses of a Strong CYP2C8 Inhibitor on the Steady-state Pharmacokinetics of Adagrasib in Healthy Adult Subjects

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	Treatment A	Oral adagrasib 200 mg twice daily (BID) for 8 days (Days 1 to 8). Predose PK blood samples for the measurement of adagrasib concentration will be collected on Days 2 to 7. Serial PK blood samples for adagrasib will be collected up to 12 hours postdose on Days 1 and 8.
DRUG	Treatment B	Oral adagrasib 200 mg BID and gemfibrozil 600 mg BID for 10 days (Days 9 to 18), with no evening dose of adagrasib or gemfibrozil on Day 18. Predose PK blood samples for the measurement of adagrasib concentration will be collected on Days 9 to 17 before the morning dose of adagrasib. Predose PK blood samples for the measurement of gemfibrozil trough concentration will be collected on Days 15 to 18 before the morning dose of gemfibrozil. Serial PK blood samples for adagrasib will be collected up to 12 hours postdose on Day 18.

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-07-25
• Completion: 2023-08-07
• First posted: 2023-05-22
• Last updated: 2024-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study