A Drug-Drug Interaction Study of MK 8527 With a Combined Oral Contraceptive (LNG/EE)

January 14, 2025 updated by: Merck Sharp & Dohme LLC

A Study to Assess the Effects of Single Oral Doses of MK-8527 on the Single-Dose Pharmacokinetics of an Oral Contraceptive (Levonorgestrel and Ethinyl Estradiol) in Healthy Adult Postmenopausal or Oophorectomized Female Subjects

This study is designed to assess the effect of a single dose of MK-8527 on the single-dose pharmacokinetics (PK) and the safety and tolerability of levonorgestrel/ethinyl estradiol (LNG/EE) in healthy adult postmenopausal or ovariectomized female participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • South Miami, Florida, United States, 33143
        • QPS-MRA, LLC-Early Phase (Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • is in good overall health
  • assigned female at birth

Exclusion Criteria:

  • has a history of clinically significant endocrine, GI, cardiovascular, hematological, thromboembolic, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years
  • has a history of cancer (malignancy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: All Participants
Participants receive single doses of LNG/EE alone and in combination with a single dose of MK-8527.
Drug: MK-8527
MK-8527 capsule taken by mouth
Drug: LNG/EE
LNG/EE combination tablet taken by mouth.
Other Names:
  • levonorgestrel/ethinyl estradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the curve from dosing to infinity (AUC0-∞) of LNG alone and with MK-8527
Time Frame: Up to ~96 hours postdose
Up to ~96 hours postdose
Maximum plasma concentration (Cmax) of LNG alone and with MK-8527
Time Frame: Up to ~96 hours postdose
Up to ~96 hours postdose
Time to Cmax (Tmax) of LNG alone and with MK-8527
Time Frame: Up to ~96 hours postdose
Up to ~96 hours postdose
Apparent half-life (t½) of LNG alone and with MK-8527
Time Frame: Up to ~96 hours postdose
Up to ~96 hours postdose
AUC0-∞ of EE alone and with MK-8527
Time Frame: Up to ~72 hours postdose
Up to ~72 hours postdose
Tmax of EE alone and with MK-8527
Time Frame: Up to ~72 hours postdose
Up to ~72 hours postdose

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with ≥1 adverse event (AE)
Time Frame: Up to ~28 days
Up to ~28 days
Percentage of participants discontinuing from study therapy due to AE
Time Frame: Up to ~28 days
Up to ~28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2023

Primary Completion (Actual)

October 11, 2023

Study Completion (Actual)

October 11, 2023

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8527-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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