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

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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