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NCT Number: NCT02536391

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

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.

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Key information

Conditions

Cancer Neoplasms

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 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.

Treatment and study plan

Ipatasertib (capsule)

Drug

Orally administered single dose of Ipatasertib formulated as a capsule.

Other names: GDC-0068 (capsule)

Ipatasertib (tablet)

Drug

Orally administered single dose of Ipatasertib formulated as a tablet.

Other names: GDC-0068 (tablet)

Primary outcomes

  1. Maximum Observed Concentration (Cmax) of Ipatasertib

    Time frame: Days 1, 8 and 15

  2. Time to Maximum Concentration (tmax) of Ipatasertib

    Time frame: Days 1, 8 and 15

  3. Area Under the Concentration-time Curve (AUC) from Hour 0 to the Last Quantifiable Concentration (AUC0-t) of Ipatasertib

    Time frame: Days 1, 8 and 15

  4. Area Under the Concentration-time Curve (AUC) from Hour 0 Extrapolated to Infinity

    Time frame: Days 1, 8 and 15

  5. Apparent Terminal Elimination Half-Life (t1/2) of Ipatasertib

    Time frame: Days 1, 8 and 15

  6. Apparent Total Clearance (CL/F) of Ipatasertib

    Time frame: Days 1, 8 and 15

  7. Apparent Volume of Distribution (Vz/F) of Ipatasertib

    Time frame: Days 1, 8 and 15

Secondary outcomes

  1. Percentage of Participants with Adverse Events

    Time frame: From check in (Day -1) to 30 days after the last dose of study drug

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 31, 2015
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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