Ipatasertib (GDC-0068) Study to Evaluate Formulation Change and Food Effect on Bioavailability in Healthy Subjects

Cancer Clinical Trial

Official title:

A Phase 1, Single-Dose, Randomized, Cross-Over, Relative Bioavailability, and Food Effect Study of Ipatasertib (GDC-0068) in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536391
• Other study ID #: GO29868
• Status: Completed
• Phase: Phase 1
• First received: August 27, 2015
• Last updated: November 1, 2016
• Start date: October 2015
• Est. completion date: November 2015

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, 3-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be determined. Participants will be randomized to one of six treatment sequences to receive three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 3 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy males or females, between 18 and 55 years of age, inclusive

• Body mass index between 18.5 and 29.9 kg/m^2, 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

• Cancer

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	Maximum Observed Concentration (Cmax) of Ipatasertib		Days 1, 8 and 15	No
Primary	Time to Maximum Concentration (tmax) of Ipatasertib		Days 1, 8 and 15	No
Primary	Area Under the Concentration-time Curve (AUC) from Hour 0 to the Last Quantifiable Concentration (AUC0-t) of Ipatasertib		Days 1, 8 and 15	No
Primary	Area Under the Concentration-time Curve (AUC) from Hour 0 Extrapolated to Infinity		Days 1, 8 and 15	No
Primary	Apparent Terminal Elimination Half-Life (t1/2) of Ipatasertib		Days 1, 8 and 15	No
Primary	Apparent Total Clearance (CL/F) of Ipatasertib		Days 1, 8 and 15	No
Primary	Apparent Volume of Distribution (Vz/F) of Ipatasertib		Days 1, 8 and 15	No
Secondary	Percentage of Participants with Adverse Events		From check in (Day -1) to 30 days after the last dose of study drug	No