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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

NCT04714554 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2021-09-01

No results posted yet for this study

Summary

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).

Conditions

  • Healthy

Interventions

DRUG

Relugolix/E2/NETA FDC

Relugolix/E2/NETA (40 mg/1 mg/0.5 mg) FDC tablet; oral administration.

DRUG

Relugolix

Relugolix 120-mg tablets; oral administration.

DRUG

Erythromycin

Erythromycin 500-mg tablets; oral administration.

Sponsors & Collaborators

  • Myovant Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • Myovant Medical Monitor · Myovant Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-06
Primary Completion
2021-03-29
Completion
2021-03-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04714554 on ClinicalTrials.gov