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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063581
• Other study ID #: GP29066
• Status: Completed
• Phase: Phase 1
• First received: February 12, 2014
• Last updated: November 1, 2016
• Start date: February 2014
• Est. completion date: March 2014

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• ipatasertib (Capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.
• ipatasertib (Tablet)
Orally administered single dose of Ipatasertib formulated as a tablet.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration time curve (AUC) of ipatasertib		Days 1-13	No
Primary	Maximum concentration (Cmax) reached of ipatasertib		Days 1-13	No
Primary	Time to maximum concentration (Tmax) of ipatasertib		Days 1-13	No
Secondary	Incidence of adverse events		From check-in (Day -1) to Day 13	No