Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Galeterone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-04-30

Brief Summary

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This is an open label, single dose, 1 period study of \[14C\] galeterone.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Single dose of [14C]-galeterone

\[14C\]-galeterone will be supplied as 325 mg capsules (powder in capsule \[PIC\]). The treatment to be administered will be 2600 mg (\~500 µCi) (8 x 325 mg capsules).

Group Type EXPERIMENTAL

galeterone

Intervention Type DRUG

Interventions

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galeterone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes