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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02536391

Enrollment

Registered

2015-08-31

Start date

2015-10-31

Completion date

2015-11-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief 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.

Interventions

DRUGIpatasertib (capsule)

Orally administered single dose of Ipatasertib formulated as a capsule.

DRUGIpatasertib (tablet)

Orally administered single dose of Ipatasertib formulated as a tablet.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Maximum Observed Concentration (Cmax) of Ipatasertib	Days 1, 8 and 15
Time to Maximum Concentration (tmax) of Ipatasertib	Days 1, 8 and 15
Area Under the Concentration-time Curve (AUC) from Hour 0 to the Last Quantifiable Concentration (AUC0-t) of Ipatasertib	Days 1, 8 and 15
Area Under the Concentration-time Curve (AUC) from Hour 0 Extrapolated to Infinity	Days 1, 8 and 15
Apparent Terminal Elimination Half-Life (t1/2) of Ipatasertib	Days 1, 8 and 15
Apparent Total Clearance (CL/F) of Ipatasertib	Days 1, 8 and 15
Apparent Volume of Distribution (Vz/F) of Ipatasertib	Days 1, 8 and 15

Secondary

Measure	Time frame
Percentage of Participants with Adverse Events	From check in (Day -1) to 30 days after the last dose of study drug

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026