NCT02074553View on ClinicalTrials.gov

A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions

Healthy Volunteer

Interventions

DRUG

Ro542-4802/F03 (Reference)

Participants will receive Ro542-4802/F03 (containing 50% SLS) 600 mg capsules orally on Day 1.

DRUG

Ro542-4802/F07 (Test)

Participants will receive Ro542-4802/F07 (containing 25% SLS) 600 mg capsules orally on Day 1.

DRUG

Ro542-4802/F08 (Test)

Participants will receive Ro542-4802/F08 (containing 3% SLS) 600 mg capsules orally on Day 1.

DRUG

Ro542-4802/F14 (Test)

Participants will receive Ro542-4802/F14 (containing 12.5% SLS) 600 mg capsules orally on Day 1.

Trial Locations (1)

78744

Austin

All Listed Sponsors

lead

Hoffmann-La Roche

INDUSTRY

NCT02074553 - A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers | Biotech Hunter | Biotech Hunter