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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02063581
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: ipatasertib (Capsule) Drug: ipatasertib (Tablet) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label Study to Evaluate the Effect of Formulation on the Bioavailability of Ipatasertib (GDC-0068) in Healthy Subjects
Study Start Date : February 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: Sequence 1: Tablet followed by Capsule Drug: ipatasertib (Capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.

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

Experimental: Sequence 2: Capsule followed by Tablet Drug: ipatasertib (Capsule)
Orally administered single dose of Ipatasertib formulated as a capsule.

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Incidence of adverse events [ Time Frame: From check-in (Day -1) to Day 13 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063581


Locations
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United States, Wisconsin
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02063581    
Other Study ID Numbers: GP29066
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016