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Completed

NCT Number: NCT02729376

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

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

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

galeterone

Drug

Primary outcomes

  1. Radioactivity concentration equivalents in plasma

    Time frame: 168 hours

  2. Single dose galeterone concentrations in plasma

    Time frame: 168 hours

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

    Time frame: 8 days

  4. Mass balance of a single [14C]galeterone dose

    Time frame: 8 days

  5. Ratio of whole blood to plasma 14C radioactivity

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

LTN PHARMACEUTICALS, INC.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2016
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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