A Performance and Bioavailability Study of Entrectinib in Healthy Volunteers.

PHASE1CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

June 6, 2019

Primary Completion Date

August 9, 2019

Study Completion Date

August 9, 2019

Conditions
Solid Tumor
Interventions
DRUG

Entrectinib 600 mg (T1)

Test formulation 1 (T1): Multi-particulate formulation 1: entrectinib film-coated mini-tablets

DRUG

Entrectinib 600 mg (T2)

Test formulation 2 (T2): Multi-particulate formulation 2: entrectinib film-coated mini-tablets

DRUG

Entrectinib 200 mg (R)

Reference formulation (R): entrectinib hard capsules

DRUG

Entrectinib 200 mg (T)

Test formulation (T): entrectinib HPMC capsules

Trial Locations (1)

NG11 6JS

Quotient Clinical Ltd, Clinical Research Unit, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY