CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 38 enrolled
Drug / intervention
GDC-0134 F09 Formulation +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03807739
NCT03807739Phase 1Completed
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A Phase I Study to Determine the Relative Bioavailability of Various Formulations of GDC-0134 in Healthy Female Subjects of Non-Childbearing Potential

Genentech, Inc.·interventional·Posted Jan 17, 2019·Updated Aug 31, 2020

In Brief

A Phase 1 clinical trial evaluating GDC-0134 F09 Formulation, GDC-0134 F15 Formulation, and 1 other intervention for Healthy Volunteers. Completed, enrolled 38 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 17, 2019
Enrollment StartFeb 1, 2019
Primary CompletionMay 30, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.5 years ago

Interventions

GDC-0134 F09 Formulationdrug

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

GDC-0134 F15 Formulationdrug

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

GDC-0134 F16 Formulationdrug

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