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A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male Subjects

NCT ID: NCT02390492

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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-04-30

Brief Summary

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This 2-period, open-label, nonrandomized study will be conducted to determine the absolute bioavailability as well as the absorption, metabolism, and excretion of ipatasertib and its metabolite(s). Healthy male participants will receive a single 200-mg oral dose of ipatasertib followed 1 hour later by an 80-mcg/800-nCi intravenous dose of \[14C\]-ipatasertib. After a 4-day observation period and 10-day washout, participants will receive a single 200-mg/100-mcCi oral dose of \[14C\]-ipatasertib with subsequent data collection for an additional 7 to 14 days until discharge criteria are met.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Ipatasertib/[14C]-ipatasertib

Group Type EXPERIMENTAL

Period 1 treatment

Intervention Type DRUG

200 mg oral ipatasertib followed 1 hour later by 80-mcg/800-nCi intravenous \[14C\]-ipatasertib on Day 1 of study

Period 2 treatment

Intervention Type DRUG

200-mg/100-mcCi oral \[14C\]-ipatasertib on Day 15 of study

Interventions

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Period 1 treatment

200 mg oral ipatasertib followed 1 hour later by 80-mcg/800-nCi intravenous \[14C\]-ipatasertib on Day 1 of study

Intervention Type DRUG

Period 2 treatment

200-mg/100-mcCi oral \[14C\]-ipatasertib on Day 15 of study

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers 18 to 55 years of age, inclusive
* Body mass index (BMI) 18 to 32 kg/m2, inclusive

Exclusion Criteria

* Females
* Clinically significant findings from medical history or screening evaluations
* Recent participation in any other investigational drug study or biologic agent study, or receipt of a previous radiolabeled investigational drug within 6 months prior to check-in
* Significant radiation exposure within 12 months prior to check-in
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

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

Other Identifiers

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GP29067

Identifier Type: -

Identifier Source: org_study_id