HealthyPhase 1NCT04714554

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

A Phase 1 study testing Relugolix/E2/NETA FDC, Relugolix and Erythromycin in people with Healthy, run by Myovant Sciences GmbH at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Relugolix/E2/NETA FDC, Relugolix and Erythromycin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: 6 Jan 2021to 29 Mar 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Study participant is considered to be medically healthy, based on a clinical evaluation including medical history, physical examinations, clinical laboratory tests, vital sign measurements, and a 12-lead electrocardiogram performed at the screening visit. Specifically, study participants should meet the following requirements at the screening visit:
Heart/pulse rate of 50 to 90 beats per minute, inclusive;
Systolic blood pressure of 90 to 139 millimeters of mercury (mmHg) and a diastolic blood pressure of 60 to 89 mmHg, inclusive;
A QT interval with Fridericia's correction (QTcF, QTcF = QT/RR(0.33)) ≤ 470 milliseconds;
Normal renal function at the screening visit, defined as an estimated creatinine clearance ≥ 90 milliliters (mL)/minute by the Cockcroft-Gault equation;
An alanine aminotransferase, aspartate aminotransferase or bilirubin value within normal limits.

Show all 10Show fewer

Part 1 only: Study participant is a female between 40 and 65 years of age, inclusive, at the screening visit.
Part 2 only: Study participant is a male between 18 and 65 years of age, inclusive, at the screening visit.
Study participant has a body mass index from ≥ 18.5 to ≤ 32.0 (Part 1) or from ≥ 18.5 to ≤ 30.0 (Part 2) (kilograms/square meter), at the screening visit.
Part 1 only: Study participant is a postmenopausal female defined as 12 months of spontaneous amenorrhea without an alternative medical cause or six weeks status post bilateral oophorectomy (with or without hysterectomy). A serum follicle-stimulating hormone (FSH) ≥ 40 milli-international units/mL is required to confirm postmenopausal status. Note: women who are amenorrheic due to a surgical procedure (hysterectomy without oophorectomy) and are considered physiologically postmenopausal based on FSH values may participate.

Who cannot join

Study participant has a clinically significant medical or psychiatric condition or disease (acute or chronic) that, as judged by the investigator, would make the study participant ineligible for participation in the study (for example, compromise the study data, limit the study participant's ability to complete and/or participate in the study).
Study participant has a current condition or history of significant endocrine, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, urologic, immunologic, or neurologic disorders that, as judged by the investigator, would make the study participant ineligible for participation in the study.
Study participants with a pre-existing condition interfering with normal gastrointestinal anatomy (with the exception of an uncomplicated appendectomy) or motility, hepatic and/or renal function that could interfere with the absorption, metabolism, and/or excretion of the study drugs.
Study participant has unconjugated bilirubin values consistent with Gilbert's syndrome or a history of or current gall bladder or bile-duct disease.
Part 1 only: Study participant has any contraindications to treatment with E2 and NETA, based on medical history:
Undiagnosed abnormal genital bleeding;

Show all 16Show fewer

Known or suspected history of breast cancer;
Known or suspected estrogen-dependent neoplasia;
Active deep vein thrombosis, pulmonary embolism, or history of these conditions;
Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions;
Known anaphylactic reaction or angioedema or hypersensitivity to estradiol or norethindrone acetate;
Known hepatic impairment or disease;
Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
Study participant has used prescription or non-prescription drugs, including vitamins and dietary or herbal supplements within 14 days (or 5 half-lives, whichever is longer) prior to study drug administration on Day 1 of Treatment Period 1, unless in the opinion of the Sponsor the medication will not interfere with interpretation of study data or compromise the safety of study participants.
Study participant has used any medication known to be a strong cytochrome P450 3A inducer and/or P glycoprotein inducer within the timeframe prior to study drug administration on Day 1 of Treatment Period 1.
Part 1 only: Study participant has used medications containing hormonal products, including injectables, within the timeframe prior to study drug administration on Day 1 of Treatment Period 1.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Pharmacology of Miami, An Evolution Research Group Portfolio Company
Hialeah, Florida, 33014

Other trials in United States

About this study

Official title: A Two-Part, Open-Label, Fixed-Sequence, Two-Period Crossover Study to Assess the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone After Administration of the Relugolix/Estradiol/Norethindrone Acetate Fixed-Dose Combination Tablet in Healthy Postmenopausal Women and on the Pharmacokinetics of Relugolix After Administration of a Single 120-mg Dose in Healthy Adult Men

Read the detailed description

Each study part consists of two sequential treatment periods (Treatment Period 1 and Treatment Period 2) in which study participants will receive study treatments in a fixed (single)-sequence, crossover manner. In Part 1 of the study, a single relugolix/E2/norethindrone acetate (NETA) (40 milligrams [mg]/1 mg/0.5 mg) fixed-dose combination (FDC) tablet will be administered alone on Day 1 of Treatment Period 1; in Treatment Period 2, erythromycin will be administered on Day 1 to Day 12 (500 mg, four times daily [QID]) with co-administration of a single FDC tablet with the morning dose of erythromycin on Day 8. In Part 2 of the study, a single 120-mg dose of relugolix will be administered alone on Day 1 of Treatment Period 1; in Treatment Period 2, erythromycin will be administered on Day 1 to Day 12 (500 mg QID) with co-administration of a single 120-mg dose of relugolix with the morning dose of erythromycin on Day 8. There will be a nine-day washout interval between administration of study drug (the FDC tablet [Part 1] or relugolix 120 mg [Part 2]) on Day 1 of Treatment Period 1 and Treatment Period 2.

Conditions: Healthy
Being tested: Relugolix/E2/NETA FDC, Relugolix, Erythromycin
Keywords: Relugolix, Estradiol, Norethindrone acetate, Erythromycin, Pharmacokinetics, Norethindrone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Relugolix/E2/NETA FDCDrug
Also called Rel-CT
Relugolix/E2/NETA (40 mg/1 mg/0.5 mg) FDC tablet; oral administration.
RelugolixDrug
Also called MVT-601, TAK-385
Relugolix 120-mg tablets; oral administration.
ErythromycinDrug
Erythromycin 500-mg tablets; oral administration.

Study groups in NCT04714554
Study group	Role	What they receive
Part 1: Relugolix/E2/NETA Plus Erythromycin	Experimental	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. Receives: Drug: Relugolix/E2/NETA FDC; Drug: Erythromycin
Part 2: Relugolix Plus Erythromycin	Experimental	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. Receives: Drug: Relugolix; Drug: Erythromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Overall Incidence Of Adverse Events
Measured: 10 Weeks
Predose Trough Plasma Concentrations (Ctrough) Of Erythromycin
Measured: Predose on Day 7 and 8 of Treatment Period 2 (Study Days 10 to 22)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 202129 Mar 2021

First posted19 Jan 2021
Study start6 Jan 2021
Primary completion29 Mar 2021
Study completion29 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Model description: In each study part (Part 1 and Part 2), study treatments will be administered in a fixed (single) sequence, crossover manner in two sequential treatment periods (Treatment Period 1 and Treatment Period 2).
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04714554
Sponsor's protocol ID: MVT-601-054
Status last verified: Aug 2021
First submitted: 8 Jan 2021
Last updated: 1 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
Brain Mapping, Healthy Volunteer
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-Part, Open-Label, Fixed-Sequence, Two-Period Crossover Study to Assess the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone After Administration of the Relugolix/Estradiol/Norethindrone Acetate Fixed-Dose Combination Tablet in Healthy Postmenopausal Women and on the Pharmacokinetics of Relugolix After Administration of a Single 120-mg Dose in Healthy Adult Men
ClinicalTrials.gov ID: NCT04714554
Acronym / sponsor ID: MVT-601-054
Conditions: Healthy
Keywords: Relugolix, Estradiol, Norethindrone acetate, Erythromycin, Pharmacokinetics, Norethindrone
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Myovant Sciences GmbHIndustry (pharma, biotech, devices)
Study start: 6 Jan 2021 (actual)
Primary completion: 29 Mar 2021 (actual)
Study completion: 29 Mar 2021 (actual)
First posted: 19 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: In each study part (Part 1 and Part 2), study treatments will be administered in a fixed (single) sequence, crossover manner in two sequential treatment periods (Treatment Period 1 and Treatment Period 2).

Arm	Type	Receives
Part 1: Relugolix/E2/NETA Plus Erythromycin	Experimental	Drug: Relugolix/E2/NETA FDC, Drug: ErythromycinTreatment 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.
Part 2: Relugolix Plus Erythromycin	Experimental	Drug: Relugolix, Drug: ErythromycinTreatment 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Study participant is considered to be medically healthy, based on a clinical evaluation including medical history, physical examinations, clinical laboratory tests, vital sign measurements, and a 12-lead electrocardiogram performed at the screening visit. Specifically, study participants should meet the following requirements at the screening visit:
Heart/pulse rate of 50 to 90 beats per minute, inclusive;
Systolic blood pressure of 90 to 139 millimeters of mercury (mmHg) and a diastolic blood pressure of 60 to 89 mmHg, inclusive;
A QT interval with Fridericia's correction (QTcF, QTcF = QT/RR(0.33)) ≤ 470 milliseconds;
Normal renal function at the screening visit, defined as an estimated creatinine clearance ≥ 90 milliliters (mL)/minute by the Cockcroft-Gault equation;

Key exclusion criteria (16 listed)

Study participant has a clinically significant medical or psychiatric condition or disease (acute or chronic) that, as judged by the investigator, would make the study participant ineligible for participation in the study (for example, compromise the study data, limit the study participant's ability to complete and/or participate in the study).
Study participant has a current condition or history of significant endocrine, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, urologic, immunologic, or neurologic disorders that, as judged by the investigator, would make the study participant ineligible for participation in the study.
Study participants with a pre-existing condition interfering with normal gastrointestinal anatomy (with the exception of an uncomplicated appendectomy) or motility, hepatic and/or renal function that could interfere with the absorption, metabolism, and/or excretion of the study drugs.
Study participant has unconjugated bilirubin values consistent with Gilbert's syndrome or a history of or current gall bladder or bile-duct disease.
Part 1 only: Study participant has any contraindications to treatment with E2 and NETA, based on medical history:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Relugolix/E2/NETA FDCAlso: Rel-CTRelugolix/E2/NETA (40 mg/1 mg/0.5 mg) FDC tablet; oral administration.	Drug	Part 1: Relugolix/E2/NETA Plus Erythromycin
RelugolixAlso: MVT-601, TAK-385Relugolix 120-mg tablets; oral administration.	Drug	Part 2: Relugolix Plus Erythromycin
ErythromycinErythromycin 500-mg tablets; oral administration.	Drug	Part 1: Relugolix/E2/NETA Plus Erythromycin, Part 2: Relugolix Plus Erythromycin

Primary outcome

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)
Maximum Plasma Concentration (Cmax) 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)

2 secondary outcomes

Overall Incidence Of Adverse Events
Time frame: 10 Weeks
Predose Trough Plasma Concentrations (Ctrough) Of Erythromycin
Time frame: Predose on Day 7 and 8 of Treatment Period 2 (Study Days 10 to 22)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
Brain Mapping, Healthy Volunteer
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Myovant Medical Monitor study director

Myovant Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Relugolix/E2/NETA FDC, Relugolix and Erythromycin in people with Healthy, run by Myovant Sciences GmbH at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04714554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.