MedTrace Logo

A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential

NCT03807739 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-08-31

Study results available
· View outcomes & findings →

Summary

This is a two-part study to determine the relative bioavailability of two different prototype capsules of GDC-0134 to that of an existing reference capsule of GDC-0134 under both fed and fasted conditions. The study is open to healthy female participants of non-childbearing potential.

Conditions

  • Healthy Volunteers

Interventions

DRUG

GDC-0134 F09 Formulation

Participants will receive a single oral dose of GDC-0134 reference capsule F09.

DRUG

GDC-0134 F15 Formulation

Participants will receive a single oral dose of GDC-0134 prototype capsule F15.

DRUG

GDC-0134 F16 Formulation

Participants will receive a single oral dose of GDC-0134 prototype capsule F16.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2019-05-30
Completion
2019-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03807739 on ClinicalTrials.gov