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A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK2248761 Administered as an Oral Suspension to Healthy Adult Subjects

NCT01273103 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-05-19

No results posted yet for this study

Summary

This study is a Phase I, open-label, single dose, mass balance study in a cohort of 6 healthy adult male subjects. The study will consist of: Screening evaluations, a treatment phase, and follow-up evaluations. In the treatment phase, after an overnight fast of at least 10 hours, each subject will receive a single oral suspension dose of GSK2248761 200mg containing \[14C\] - GSK2248761. Following dosing, serial whole blood, plasma, urine, and fecal samples will be collected. Subjects will be required to remain in the unit until the radiocarbon excreted falls to less than or equal to 1% of the administered dose for two consecutive 24-hour collections in both urine and feces, whichever occurs first. Safety will be assessed by vital signs, 12-lead electrocardiogram (ECG), clinical laboratory tests, AE monitoring, and physical examinations as indicated.

Conditions

  • Infection, Human Immunodeficiency Virus

Interventions

DRUG

200mg [14C]- GSK2248761

single oral suspension dose of \[14C\]- GSK2248761 200 mg

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01273103 on ClinicalTrials.gov