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

Phase 1

Completed

• Conditions: Human Immunodeficiency Virus (HIV); HIV Pre-Exposure Prophylaxis
• Interventions: Drug: MK-8527; Drug: LNG/EE

• Registration Number: NCT06783192
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-14
• Primary Completion: 2023-10-11
• Study Completion: 2023-10-11
• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1: All Participants	MK-8527	Participants receive single doses of LNG/EE alone and in combination with a single dose of MK-8527.
Arm 1: All Participants	LNG/EE	Participants receive single doses of LNG/EE alone and in combination with a single dose of MK-8527.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with ≥1 adverse event (AE)	Up to ~28 days
Percentage of participants discontinuing from study therapy due to AE	Up to ~28 days

Trial Locations

Locations (1)

QPS-MRA, LLC-Early Phase (Site 0001); 🇺🇸 South Miami, Florida, United States