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

NCT ID: NCT06312761

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

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.

Conditions

Hypogonadism, Male

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Arm 1 Oral testosterone undecanoate without Curcumin

Oral testosterone undecanoate 237 mg Day 2

Group Type: EXPERIMENTAL

Testosterone Undecanoate 237 MG Oral Capsule

Intervention Type: DRUG

Testosterone Undecanoate 237 MG Oral Capsule

Arm 2 Oral testosterone undecanoate with Curcumin

Oral testosterone undecanoate 237 mg \& Curcumin 630 mg Day 3

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DIETARY_SUPPLEMENT

Curcumin 630 mg single dose

Testosterone Undecanoate 237 MG Oral Capsule

Intervention Type: DRUG

Testosterone Undecanoate 237 MG Oral Capsule

Relugolix 120 mg single dose

All subjects will received Relugoliz on Day 1

Group Type: OTHER

Relugolix 120Mg Tab

Intervention Type: DRUG

Relugolix 120 mg single dose - All subjects

Interventions

Relugolix 120Mg Tab

Relugolix 120 mg single dose - All subjects

Intervention Type: DRUG

Curcumin

Curcumin 630 mg single dose

Intervention Type: DIETARY_SUPPLEMENT

Testosterone Undecanoate 237 MG Oral Capsule

Testosterone Undecanoate 237 MG Oral Capsule

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Washington State University

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

John Amory

Professor, DOM - General Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Amory, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Central Contacts

John Amory, MD

Role: CONTACT

jamory@uw.edu

206-616-1727

Kathy Winter

Role: CONTACT

klwinter@uw.edu

206-616-0484

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Other Identifiers

Oral T-12

Identifier Type: -

Identifier Source: org_study_id