NCT02729376

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

1 month

First QC Date

February 26, 2016

Last Update Submit

September 2, 2020

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

Single dose of [14C]-galeterone

EXPERIMENTAL

\[14C\]-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

Interventions

galeteroneDRUG
Single dose of [14C]-galeterone

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

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

Study Officials

  • Karen J Ferrante, MD

    Tokai Pharmaceuticals, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2016

First Posted

April 6, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)