NCT01980953

A Study to Evaluate the Effect of Particle Size, Formulation and Food on the Pharmacokinetics of GDC-0032 in Healthy Volunteers

A Phase 1, Open-Label Study to Evaluate the Effect of Particle Size, Formulation, and Food on the Pharmacokinetics of GDC-0032 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This 4-part study will assess the effect of formulation, food, and active pharmaceutical ingredient (API) lot on the pharmacokinetics of GDC-0032 in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study, and Parts 2, 3, and 4 are open-label 2-period crossover studies. Participants will receive single doses of GDC-0032 capsule or tablet formulation, in the fasted or fed state.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	GDC-0032 Phase III Tablet	Participants will receive 2 mg or 3 mg Phase III tablet after 10 hour fasting from food.
DRUG	GDC-0032 Tablet	Participants will receive 3 mg Tablet A or Tablet B formulation after 10 hour fasting from food.
DRUG	GDC-0032 Capsule	Participants will receive 3 mg GDC-0032 capsule formulation after 10 hour fasting from food.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-11-11
• Last updated: 2017-02-01

Locations

1 site across 1 country: United States