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
- Conditions
- Inflammatory Bowel Diseaseirritable bowel syndrome1001796910003816
- Registration Number
- NL-OMON55161
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 114
- Age 18 to 55 years, inclusive
- Body mass index between 18 and 30 kg/m2, inclusive
- Ability to comply with the study protocol, in the investigator's judgment
- Expressed willingness to participate in the entire study
- For women of childbearing potential: use contraception as described in
protocol.
For men: use a condom, and agreement to refrain from donating sperm, as
defined in protocol
- For subjects screened at PRA Health Sciences: meeting of site-specific
COVID-19 criteria
- Pregnant or breastfeeding, or intending to become pregnant during the study
or within 90 days or 5 half-lives of GDC-8264, whichever is longer, after the
final dose of study drug
- Treatment with investigational therapy within 90 days prior to initiation of
study drug
- Participation in more than four other drug studies in the 12 months prior to
drug administration in the current study
- Subjects who have been previously enrolled in this study
- Study site employees or immediate family members of a study site or Sponsor
employee
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The safety objective for this study is to evaluate the safety and tolerability<br /><br>of single and multiple doses of GDC 8264 compared with placebo in healthy<br /><br>subjects </p><br>
- Secondary Outcome Measures
Name Time Method <p>To characterize the pharmacokinetics of GDC 8264. </p><br>