A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male Subjects

Genentech

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Period 1 treatment; Drug: Period 2 treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02390492

GP29067

Details and patient eligibility

About

This 2-period, open-label, nonrandomized study will be conducted to determine the absolute bioavailability as well as the absorption, metabolism, and excretion of ipatasertib and its metabolite(s). Healthy male participants will receive a single 200-mg oral dose of ipatasertib followed 1 hour later by an 80-mcg/800-nCi intravenous dose of [14C]-ipatasertib. After a 4-day observation period and 10-day washout, participants will receive a single 200-mg/100-mcCi oral dose of [14C]-ipatasertib with subsequent data collection for an additional 7 to 14 days until discharge criteria are met.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers 18 to 55 years of age, inclusive
• Body mass index (BMI) 18 to 32 kg/m2, inclusive

Exclusion criteria

• Females
• Clinically significant findings from medical history or screening evaluations
• Recent participation in any other investigational drug study or biologic agent study, or receipt of a previous radiolabeled investigational drug within 6 months prior to check-in
• Significant radiation exposure within 12 months prior to check-in

Trial design

8 participants in 1 patient group

Ipatasertib/[14C]-ipatasertib

Experimental group

Treatment:

Drug: Period 1 treatment

Drug: Period 2 treatment