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

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

July 25, 2023

Study Completion Date

August 7, 2023

Conditions
Healthy Adults
Interventions
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.

Trial Locations (1)

75247

Labcorp Clinical Research Unit Inc, Dallas

Sponsors
All Listed Sponsors
lead

Mirati Therapeutics Inc.

INDUSTRY

NCT05868356 - A PK Study to Assess the Drug-drug Interaction of a Strong CYP2C8 Inhibitor on Adagrasib | Biotech Hunter | Biotech Hunter