MedTrace Logo

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

NCT02390492 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-11-02

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Period 1 treatment

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

DRUG

Period 2 treatment

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

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02390492 on ClinicalTrials.gov