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

LTN PHARMACEUTICALS, INC.6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

galeteroneDRUG

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Celerion

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Radioactivity concentration equivalents in plasma

Time frame: 168 hours

Single dose galeterone concentrations in plasma

Time frame: 168 hours

Route(s) of elimination of a single [14C]galeterone dose

Time frame: 8 days

Mass balance of a single [14C]galeterone dose

Time frame: 8 days

Ratio of whole blood to plasma 14C radioactivity

Time frame: 24 hours

Data from ClinicalTrials.gov

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