Relative Bioavailability of Two Tepotinib Film-Coated Tablet Formulations in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions
Healthy
Interventions
DRUG

Tepotinib test (Treatment Period 1)

Subjects will be administered a single oral dose of test treatment of film-coated tepotinib tablet (1 \* 500 mg tablet) in Treatment period 1 (Day 1)

DRUG

Tepotinib reference (Treatment Period 2)

Followed by a 21-day washout after Treatment period 1 (Day 1), subjects will be administered a single oral dose of reference treatment of film-coated tepotinib tablet (5 \* 100 mg tablet) in Treatment period 2 (Day 22)

DRUG

Tepotinib reference (Treatment Period 1)

Subjects will be administered a single oral dose of reference treatment of film-coated tepotinib tablet (5 \* 100 mg tablet) in Treatment period 1 (Day 1)

DRUG

Tepotinib test (Treatment Period 2)

Followed by a 21-day washout after Treatment period 1 (Day 1), subjects will be administered a single oral dose of test treatment of film-coated tepotinib tablet (1 \* 500 mg tablet) in Treatment period 2 (Day 22)

Trial Locations (1)

Unknown

For Recruiting Locations outside US, please Contact Merck KGaA Communication Center, Darmstadt

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT03021642 - Relative Bioavailability of Two Tepotinib Film-Coated Tablet Formulations in Healthy Volunteers | Biotech Hunter | Biotech Hunter