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Completed

NCT Number: NCT06783192

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

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.

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Key information

Conditions

Human Immunodeficiency Virus (HIV) Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Pre-Exposure Prophylaxis Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

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

South Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MK-8527

Drug

MK-8527 capsule taken by mouth

LNG/EE

Drug

LNG/EE combination tablet taken by mouth.

Other names: levonorgestrel/ethinyl estradiol

Primary outcomes

  1. Area under the curve from dosing to infinity (AUC0-∞) of LNG alone and with MK-8527

    Time frame: Up to ~96 hours postdose

  2. Maximum plasma concentration (Cmax) of LNG alone and with MK-8527

    Time frame: Up to ~96 hours postdose

  3. Time to Cmax (Tmax) of LNG alone and with MK-8527

    Time frame: Up to ~96 hours postdose

  4. Apparent half-life (t½) of LNG alone and with MK-8527

    Time frame: Up to ~96 hours postdose

  5. AUC0-∞ of EE alone and with MK-8527

    Time frame: Up to ~72 hours postdose

  6. Tmax of EE alone and with MK-8527

    Time frame: Up to ~72 hours postdose

Secondary outcomes

  1. Percentage of participants with ≥1 adverse event (AE)

    Time frame: Up to ~28 days

  2. Percentage of participants discontinuing from study therapy due to AE

    Time frame: Up to ~28 days

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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