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

NCT ID: NCT02536391

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1: Tablet/Capsule/Tablet with food

Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after high-fat meal.

Group Type EXPERIMENTAL

Ipatasertib (capsule)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a capsule.

Ipatasertib (tablet)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a tablet.

Sequence 2: Tablet/Tablet with food/Capsule

Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib capsule administered after fast.

Group Type EXPERIMENTAL

Ipatasertib (capsule)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a capsule.

Ipatasertib (tablet)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a tablet.

Sequence 3: Capsule/Tablet/Tablet with food

Day 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib tablet administered after high-fat meal.

Group Type EXPERIMENTAL

Ipatasertib (capsule)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a capsule.

Ipatasertib (tablet)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a tablet.

Sequence 4: Capsule/Tablet with food/Tablet

Day 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib tablet administered after fast.

Group Type EXPERIMENTAL

Ipatasertib (capsule)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a capsule.

Ipatasertib (tablet)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a tablet.

Sequence 5: Tablet with food/Tablet/Capsule

Day 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib capsule administered after fast.

Group Type EXPERIMENTAL

Ipatasertib (capsule)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a capsule.

Ipatasertib (tablet)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a tablet.

Sequence 6: Tablet with food/Capsule/Tablet

Day 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after fast.

Group Type EXPERIMENTAL

Ipatasertib (capsule)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a capsule.

Ipatasertib (tablet)

Intervention Type DRUG

Orally administered single dose of Ipatasertib formulated as a tablet.

Interventions

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Ipatasertib (capsule)

Orally administered single dose of Ipatasertib formulated as a capsule.

Intervention Type DRUG

Ipatasertib (tablet)

Orally administered single dose of Ipatasertib formulated as a tablet.

Intervention Type DRUG

Other Intervention Names

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GDC-0068 (capsule) GDC-0068 (tablet)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Malhi V, Budha N, Sane R, Huang J, Liederer B, Meng R, Patel P, Deng Y, Cervantes A, Tabernero J, Musib L. Single- and multiple-dose pharmacokinetics, potential for CYP3A inhibition, and food effect in patients with cancer and healthy subjects receiving ipatasertib. Cancer Chemother Pharmacol. 2021 Dec;88(6):921-930. doi: 10.1007/s00280-021-04344-9. Epub 2021 Sep 1.

Reference Type DERIVED
PMID: 34471960 (View on PubMed)

Other Identifiers

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GO29868

Identifier Type: -

Identifier Source: org_study_id