A Study Evaluating the Effect of Formulation on the Bioavailability of Ipatasertib in Healthy Volunteers

Genentech

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: ipatasertib (Tablet); Drug: ipatasertib (Capsule)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02063581

GP29066

Details and patient eligibility

About

This Phase I, open-label, randomized, 2-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy adult volunteers. Participants will be randomized to one of two treatment sequences to receive a single oral administration of ipatasertib in tablet or capsule formulation followed, after a washout period, by a single oral administration of ipatasertib in the second formulation. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 2 weeks.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female volunteers aged 18 to 55 years, inclusive
• Body mass index (BMI) from 18.5-29.9 kg/m2, inclusive

Exclusion criteria

• Clinically significant findings from medical history or screening evaluations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Sequence 1: Tablet followed by Capsule

Experimental group

Treatment:

Drug: ipatasertib (Capsule)

Drug: ipatasertib (Tablet)

Sequence 2: Capsule followed by Tablet

Experimental group

Treatment:

Drug: ipatasertib (Capsule)

Drug: ipatasertib (Tablet)