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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.
 
ClinicalTrials.gov Identifier: NCT02729376
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Novus Therapeutics, Inc

Tracking Information
First Submitted Date  ICMJE February 26, 2016
First Posted Date  ICMJE April 6, 2016
Last Update Posted Date April 27, 2016
Study Start Date  ICMJE March 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02729376 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Galeterone
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: galeterone
Study Arms  ICMJE 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).
Intervention: Drug: galeterone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2016)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02729376
Other Study ID Numbers  ICMJE TOK-200-18
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Novus Therapeutics, Inc
Study Sponsor  ICMJE Novus Therapeutics, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Karen J Ferrante, MD Tokai Pharmaceuticals, Inc.
PRS Account Novus Therapeutics, Inc
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP