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Radiolabeled Study of AG-221 in Healthy Male Subjects.

NCT02443168 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-10-30

No results posted yet for this study

Summary

This is a single-center, 2-part, open-label study to evaluate the metabolism and excretion and absolute bioavailability of \[14C\]-AG-221 in healthy male subjects. It is planned for 14 subjects to be enrolled; each subject will participate in a screening phase, a baseline phase, a treatment phase, and a follow up phone call. Blood, urine and fecal samples will be collected in Part 1 for analyses. Blood samples will be collected in Part 2. Subjects can only participate in either Part 1 or Part 2.

Conditions

  • Healthy Volunteers

Interventions

DRUG

AG-221

Part 1: oral solution containing 100 mg \[14C\]-AG-221

RADIATION

14C AG-221

5 mL of 100 micrograms \[14C\] AG-221 given intravenously 4 hours after swallowing the formulated tablet.

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Edward O'Mara, MD · Celgene Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-05-14
Primary Completion
2015-07-21
Completion
2015-07-21

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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 NCT02443168 on ClinicalTrials.gov