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

NCT06783192 | Completed Phase 1 FDA Drug

• 1 other identifier: 8527-006
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus (HIV); HIV Pre-Exposure Prophylaxis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• 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

Study Arms (1)

Arm 1: All Participants

EXPERIMENTAL

Participants receive single doses of LNG/EE alone and in combination with a single dose of MK-8527.

Drug: MK-8527; Drug: LNG/EE

Interventions

MK-8527 DRUG

MK-8527 capsule taken by mouth

Arm 1: All Participants

LNG/EE DRUG

LNG/EE combination tablet taken by mouth.

Also known as: levonorgestrel/ethinyl estradiol

Arm 1: All Participants

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• is in good overall health
• assigned female at birth

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

QPS-MRA, LLC-Early Phase (Site 0001)

South Miami, Florida, 33143, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Ethinyl Estradiol-Norgestrel Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: August 14, 2023
• Primary Completion: October 11, 2023
• Study Completion: October 11, 2023
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)