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Trial record 3 of 11 for:    "Otic Pharma" OR "Novus Therapeutics" OR "Tokai Pharmaceuticals"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02729376
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : April 27, 2016
Information provided by (Responsible Party):
Novus Therapeutics, Inc

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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 : March 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

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

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02729376

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United States, Nebraska
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Novus Therapeutics, Inc
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Study Chair: Karen J Ferrante, MD Tokai Pharmaceuticals, Inc.

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Responsible Party: Novus Therapeutics, Inc Identifier: NCT02729376    
Other Study ID Numbers: TOK-200-18
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novus Therapeutics, Inc:
Healthy Volunteers
Additional relevant MeSH terms:
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Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action