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

Sponsor
University of Washington
Study ID
NCT06312761
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Hypogonadism, Male

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Relugolix 120Mg Tab — DRUG
    Relugolix 120 mg single dose - All subjects
  • Curcumin — DIETARY_SUPPLEMENT
    Curcumin 630 mg single dose
  • Testosterone Undecanoate 237 MG Oral Capsule — DRUG
    Testosterone Undecanoate 237 MG Oral Capsule

Study Details

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.

Key Dates

First listed
Mar 15, 2024
Start date
Jun 1, 2024
Status verified
Mar 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Arm 1 Oral testosterone undecanoate without Curcumin
    Oral testosterone undecanoate 237 mg Day 2
  • Experimental: Arm 2 Oral testosterone undecanoate with Curcumin
    Oral testosterone undecanoate 237 mg \& Curcumin 630 mg Day 3
  • Other: Relugolix 120 mg single dose
    All subjects will received Relugoliz on Day 1

Primary Outcome Measure

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) ]

Central Contacts

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