Healthy
Conditions
Keywords
Healthy Volunteers
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.
Interventions
DRUGgaleterone
Sponsors
LTN PHARMACEUTICALS, INC.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed