Inflammatory Bowel Disease irritable bowel syndrome
Conditions
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
Sponsors
Genentech, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety objective for this study is to evaluate the safety and tolerability of single and multiple doses of GDC 8264 compared with placebo in healthy subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the pharmacokinetics of GDC 8264. | — |
Countries
Netherlands
Outcome results
None listed