CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
GDC-0973 IV Infusion +1 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/NCT01249118
NCT01249118Phase 1Completed

A Phase 1, Single Dose, Randomized, Cross-over Absolute Bioavailability Study in Healthy Subjects Comparing Oral to Intravenous Administration of GDC-0973

Genentech, Inc.·interventional·Posted Nov 29, 2010·Updated May 10, 2017

In Brief

A Phase 1 clinical trial evaluating GDC-0973 IV Infusion and GDC-0973 Oral Capsules for Healthy Volunteers. Completed, enrolled 13 participants.

Detailed Summary

The primary objective of Part 1 of this study is to evaluate the safety and tolerability of the intravenous (IV) dose of GDC-0973. The primary objectives of Part 2 of this study are to evaluate the absolute bioavailability of GDC-0973 and to evaluate the pharmacokinetic (PK) of GDC-0973 following IV and oral administration. The secondary objective of Part 2 of this study is to evaluate the safety of GDC-0973 administered orally and intravenously.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 29, 2010
Enrollment StartNov 1, 2010
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.6 years ago

Interventions

GDC-0973 IV Infusiondrug

IV infusion.

GDC-0973 Oral Capsulesdrug

Oral dose.