Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Galeterone
Status: | Active, not recruiting |
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Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 19 - 55 |
Updated: | 4/21/2016 |
Start Date: | March 2016 |
End Date: | April 2016 |
An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Galeterone in Healthy Male Subjects After Oral Administration
This is an open label, single dose, 1 period study of [14C] galeterone.
This is an open label, 1 period study under fed conditions. Six (6), healthy, adult, non
tobacco using, male subjects will be enrolled. Screening of subjects will occur within 28
days prior to dosing. On Day 1, a single dose of radio-labeled galeterone will be
administered orally. Blood, urine, and fecal samples will be collected until release
criteria are met to measure total radioactivity, for analysis of galeterone concentrations,
and for potential metabolic profiling.
tobacco using, male subjects will be enrolled. Screening of subjects will occur within 28
days prior to dosing. On Day 1, a single dose of radio-labeled galeterone will be
administered orally. Blood, urine, and fecal samples will be collected until release
criteria are met to measure total radioactivity, for analysis of galeterone concentrations,
and for potential metabolic profiling.
Inclusion Criteria:
1. Healthy, adult, male, 19 to 55 years of age, inclusive, at screening.
2. Continuous non smoker who has not used nicotine containing products for at least 3
months prior to dosing.
3. Understands the study procedures in the informed consent form (ICF), and be willing
and able to comply with the protocol.
Exclusion Criteria:
1. History or presence of clinically significant medical or psychiatric condition or
disease in the opinion of the PI.
2. History of any illness that, in the opinion of the PI, might confound the results of
the study or poses an additional risk to the subject by their participation in the
study.
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