Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17

Launched by UNIVERSITY OF WASHINGTON · Mar 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a single dose of oral testosterone undecanoate is absorbed and processed in the body, especially when taken with a medication that affects testosterone levels. The study will involve healthy men aged 18 to 55 who will temporarily have their natural testosterone production lowered to help researchers understand how well the testosterone medication works under these conditions.

To participate, men must be in good health and agree not to take any other medications or participate in other drug studies during the trial. They also need to provide written consent and follow specific guidelines, including using contraception. The study is not yet recruiting participants, but if you're eligible, you can expect to take the study medication and undergo monitoring to see how your body reacts to it. This research could help improve treatments for conditions like hypogonadism, which is when the body doesn’t produce enough testosterone.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. healthy male between 18 and 55 years of age
• • 2. agrees to not participate in another drug research study for the duration of this study
• • 3. agrees to not donate blood during the study
• • 4. subject provided written (personally signed and dated) informed consent before completing any study-related procedures
• • 5. subject able and willing to comply with the protocol
• • 6. subject able and willing to not take medications other than the study drug for the duration of the study
• Exclusion Criteria:
• • 1. subject has poor general health, determined by medical history or physical exam
• • 2. subject have an abnormal evaluation on screening exam (consisting of serum chemistry, hematology and baseline hormone levels)
• • 3. subject have a known history or current use of alcohol drug or steroid abuse and/or the use of more than 3 alcoholic beverages per day
• • 4. History of current testosterone use
• • 5. History of testicular disease or severe testicular trauma
• • 6. History of major psychiatric disorder
• • 7. subject participated in a hormonal drug study within the past month
• • 8. Subject or his partner(s) NOT willing to use an accepted method of contraception during the study
• • 9. History of Bleeding disorders or current use of anti-coagulants