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Mass Balance, Pharmacokinetics and Metabolism Study of Alisertib

NCT01714947 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-10-31

Study results available
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Summary

The purpose of this study is to assess the mass balance (i.e. cumulative excretion of total radioactivity \[TRA\] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in plasma and urine, and of TRA in plasma and whole blood.

Conditions

Interventions

DRUG

[^14C]-alisertib

\[\^14C\]-alisertib oral solution

DRUG

alisertib

Alisertib enteric coated tablets

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-24
Primary Completion
2013-04-04
Completion
2013-06-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01714947 on ClinicalTrials.gov