Trial Details

Not Recruiting
Basic Information
Clinical ID c2585
Identifier NL-OMON55161
Trial Title A PHASE I, RANDOMIZED, DOUBLE BLINDED, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING DOSES OF ORAL GDC-8264 AND THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF GDC-8264 IN HEALTHY VOLUNTEERS - GDC-8264 SAD/MAD/FE Study_
Trial URL Visit Original Page
Study Information
Study Results

Yes
Conditions Inflammatory Bowel Disease irritable bowel syndrome;10017969;10003816
Interventions The subjects will receive a single or multiple doses of GDC-8264 or placebo as tablets orally with 240 milliliters (mL) of water, or as a suspension. The starting dose is 5 mg. Midazolam is given through a syringe without a needle in the mouth, after which it can be swallowed. One also gets 200 ml of water to rinse the mouth and to swallow. Midazolam is given after 8 hours of fasting. In addition, fasting continues for up to 4 hours after ingestion. Two single doses of midazolam of 5 mg each are given: once on Day 1 and once on Day 10.
Participant Information
Sponsor Genentech, Inc.
City -
Country/Region Netherlands
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement ADULT
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date 2022-05-20
Completion Date 2021-10-13