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

NCT ID: NCT02063581

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1: Tablet followed by Capsule

Group Type EXPERIMENTAL

ipatasertib (Capsule)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a capsule.

ipatasertib (Tablet)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a tablet.

Sequence 2: Capsule followed by Tablet

Group Type EXPERIMENTAL

ipatasertib (Capsule)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a capsule.

ipatasertib (Tablet)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a tablet.

Interventions

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ipatasertib (Capsule)

Orally administered single dose of Ipatasertib formulated as a capsule.

Intervention Type DRUG

ipatasertib (Tablet)

Orally administered single dose of Ipatasertib formulated as a tablet.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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GP29066

Identifier Type: -

Identifier Source: org_study_id