A Study of the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone in Healthy Postmenopausal Women and on the Pharmacokinetics of Relugolix in Healthy Adult Men

Part of paid clinical trials in Hialeah, Florida.

Sponsor
Myovant Sciences GmbH
Study ID
NCT04714554
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Relugolix/E2/NETA FDC — DRUG
    Relugolix/E2/NETA (40 mg/1 mg/0.5 mg) FDC tablet; oral administration.
  • Relugolix — DRUG
    Relugolix 120-mg tablets; oral administration.
  • Erythromycin — DRUG
    Erythromycin 500-mg tablets; oral administration.

Study Details

This is a two-part, open-label, fixed-sequence, two-period crossover drug interaction study to assess the potential effects of erythromycin on the pharmacokinetics of relugolix, estradiol (E2), and norethindrone (NET) in healthy postmenopausal women (Part 1) and the pharmacokinetics of relugolix in healthy adult men (Part 2).

Key Dates

Start date
Jan 6, 2021
Status verified
Aug 2021
Primary completion
Mar 29, 2021
Completion
Mar 29, 2021

Study Design

Enrollment
43 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Relugolix/E2/NETA Plus Erythromycin
    Treatment Period 1: Healthy premenopausal women will receive a relugolix/E2/NETA (40 mg/1 mg/0.5 mg) alone on Day 1. Treatment Period 2: Healthy premenopausal women will receive erythromycin on Day 1 through 12 (500 mg, QID), with co-administration of a single dose of relugolix/E2/NETA (40 mg/1 mg/0.5 mg) with the morning dose of erythromycin on Day 8.
  • Experimental: Part 2: Relugolix Plus Erythromycin
    Treatment Period 1: Male participants will receive a single 120-mg dose of relugolix alone on Day 1. Treatment Period 2: Male participants will receive erythromycin on Days 1 through 12 (500 mg, QID), with co-administration of a single 120-mg dose of relugolix with the morning dose of erythromycin on Day 8.

Primary Outcome Measure

Area Under The Concentration-time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Relugolix Or Other Analytes [ Time Frame: Day 8 predose and up to 120 hours postdose at multiple time points during Treatment Period 2 (Study Days 10 to 22) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of Miami, An Evolution Research Group Portfolio CompanyHialeahFlorida33014-

Find similar trials in Hialeah, FL

By research site
Clinical Pharmacology of Miami, An Evolution Research Group Portfolio Company· Hialeah, FL

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