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

Sponsor

Educational & Scientific LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02729376

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: galeterone	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Drug: galeterone

Arm

Intervention/Treatment

Experimental: 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).

Drug: galeterone

Outcome Measures

Primary Outcome Measures

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]
Mass balance of a single [14C]galeterone dose [8 days]
Ratio of whole blood to plasma 14C radioactivity [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy, adult, male, 19 to 55 years of age, inclusive, at screening.
Continuous non smoker who has not used nicotine containing products for at least 3 months prior to dosing.
Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion	Lincoln	Nebraska	United States	68502

Sponsors and Collaborators

Educational & Scientific LLC

Investigators

Study Chair: Karen J Ferrante, MD, Tokai Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Educational & Scientific LLC

ClinicalTrials.gov Identifier:

NCT02729376

Other Study ID Numbers:

TOK-200-18

First Posted:

Apr 6, 2016

Last Update Posted:

Sep 4, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Educational & Scientific LLC

Healthy Volunteers

Additional relevant MeSH terms:

3-hydroxy-17-(1H-benzimidazole-1-yl)androsta-5,16-diene

Study Results

No Results Posted as of Sep 4, 2020