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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: galeterone

• Registration Number: NCT02729376
• Lead Sponsor: LTN PHARMACEUTICALS, INC.

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2016-02-26
• Study Start: 2016-03
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single dose of [14C]-galeterone	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).

Primary Outcome Measures

Name	Time	Method
Mass balance of a single [14C]galeterone dose	8 days
Radioactivity concentration equivalents in plasma	168 hours
Single dose galeterone concentrations in plasma	168 hours
Route(s) of elimination of a single [14C]galeterone dose	8 days
Ratio of whole blood to plasma 14C radioactivity	24 hours

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States