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Completed

NCT Number: NCT02063581

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipatasertib (capsule)

Drug

Orally administered single dose of Ipatasertib formulated as a capsule.

Ipatasertib (tablet)

Drug

Orally administered single dose of Ipatasertib formulated as a tablet.

Primary outcomes

  1. Area under the concentration time curve (AUC) of ipatasertib

    Time frame: Days 1-13

  2. Maximum concentration (Cmax) reached of ipatasertib

    Time frame: Days 1-13

  3. Time to maximum concentration (Tmax) of ipatasertib

    Time frame: Days 1-13

Secondary outcomes

  1. Incidence of adverse events

    Time frame: From check-in (Day -1) to Day 13

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-Label Study to Evaluate the Effect of Formulation on the Bioavailability of Ipatasertib (GDC-0068) in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 14, 2014
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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