Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17 (OralT12)

March 8, 2024 updated by: John Amory, University of Washington

Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17 With Oral Curcumin in Normal Men With Experimental Hypogonadism

This study will be performed in normal men whose endogenous testosterone production has been temporarily suppressed by the administration of a single dose of 120 mg of the oral GnRH antagonist Relugolix, which is approved for the treatment of prostate cancer, and can suppress endogenous testosterone biosynthesis for 48-72 hours after a single dose.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will have three phases: a screening period, a 3-day drug exposure period, and a one-month recovery period (see Table 1, Experimental Design).

Screening Visit: At screening, study investigators will consent subjects, perform an interview and physical examination; blood samples for measurement of hormones (T,

DHT, Estradiol (E2), FSH and LH), routine hematology, chemistry and hepatic function and a DNA sample for UGT2B17 genotype will be obtained from the buccal mucosa and a spot urine specimen obtained for a testosterone glucuronide/androsterone glucuronide ratio (a marker of endogenous UGT2B17 activity). No drugs will be administered in the screening period. The screening visit should take approximately 60 minutes.

Day 1 (15-minute visit): Blood pressure and heart rate will be measured prior to the administration of Relugolix 120 mg orally on an empty stomach.

Day 2 (9 hour stay): Placement of IV and dosing of Testosterone Undecanoate 237 mg once with two ensures. The first dose of oral testosterone will be administered at 0900 (+/- 30 minutes) in the morning with two Ensures. After drug administration, subjects will have 10 ccs of blood drawn for the measurement of serum testosterone for the measurement of testosterone Predose, 0.5, 1, 1.5 2, 3, 4, 6, and 8 hours after the morning dose and will have the iv removed.

Day 3 (9 hour stay): Placement of IV and dosing of Testosterone Undecanoate 237 mg once with two Ensures and 630 mg of oral Curcumin. The second dose of oral testosterone will be administered at 0900 (+/- 30 minutes) in the morning. After drug administration, subjects will have 10 ccs of blood drawn for the measurement of serum testosterone for the measurement of testosterone Predose, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after the morning dose and will have the iv removed.

Day 4 (15-minute visit): Subjects will come into the clinic at 0900 for a 24-hour blood draw and adverse effect assessment.

Day 28-42 (30-minute visit): Subjects will undergo a final assessment (physical examination, vitals and weight measurements and blood draw) on day 28-42. We will confirm at the follow-up visit that there has been recovery from Relugolix-induced hypogonadism (i.e., testosterone levels have returned to within 25% of baseline). If a subject has not recovered by this visit, he will be reassessed at 2-week intervals until recovery is documented. The total amount of blood drawn over the study protocol will not exceed 500 mL per subject.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: John Amory, MD
  • Phone Number: 206-616-1727
  • Email: jamory@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 Oral testosterone undecanoate without Curcumin
Oral testosterone undecanoate 237 mg Day 2
Drug: Testosterone Undecanoate 237 MG Oral Capsule
Testosterone Undecanoate 237 MG Oral Capsule
Experimental: Arm 2 Oral testosterone undecanoate with Curcumin
Oral testosterone undecanoate 237 mg & Curcumin 630 mg Day 3
Drug: Testosterone Undecanoate 237 MG Oral Capsule
Testosterone Undecanoate 237 MG Oral Capsule
Dietary supplement: Curcumin
Curcumin 630 mg single dose
Other: Relugolix 120 mg single dose
All subjects will received Relugoliz on Day 1
Drug: Relugolix 120Mg Tab
Relugolix 120 mg single dose - All subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
average serum testosterone after dosing on day 2
Time Frame: 24 hour period (between dosing at beginning of day 2 and end of day 2)
24 hour period (between dosing at beginning of day 2 and end of day 2)
average serum testosterone after dosing on day 3
Time Frame: 24 hour period (between dosing at beginning of day 3 and end of day 3)
24 hour period (between dosing at beginning of day 3 and end of day 3)
Maximum concentration
Time Frame: Cmax during 24 hour period (between dosing at beginning of day 2 and 3 and end of day 2 or day 3)
Cmax during 24 hour period (between dosing at beginning of day 2 and 3 and end of day 2 or day 3)
time to maximum concentration
Time Frame: T max during 24 hour period (between dosing at beginning of day 2 and 3 and end of day 2 or day 3)
T max during 24 hour period (between dosing at beginning of day 2 and 3 and end of day 2 or day 3)
area-under-the curve
Time Frame: 24 hour period (between dosing at beginning of day 2 and 3 and end of day 2 or day 3)
24 hour period (between dosing at beginning of day 2 and 3 and end of day 2 or day 3)
elimination phase half-life
Time Frame: 24 hour period (between dosing at beginning of day 2 and 3 and end of day 2 or day 3)
24 hour period (between dosing at beginning of day 2 and 3 and end of day 2 or day 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Washington State University

Investigators

  • Principal Investigator: John Amory, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oral T-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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