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Completed

NCT Number: NCT07063238

A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014)

Researchers are looking for new medicines to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. Medicines to prevent HIV-1 infection are called pre-exposure prophylaxis (PrEP). Some people may have trouble following a PrEP plan because it involves either taking medicine everyday by mouth or getting injections (shots) often.

MK-8527 is a study medicine designed to prevent HIV-1 infection. MK-8527 is different from standard (usual) PrEP because it is taken once a month, by mouth, as a tablet.

The goal of this study is to learn if taking a higher-than-normal dose of MK-8527 increases the QT interval (a measure of heart rhythm) by a certain amount.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hassman Research Institute Marlton Site ( Site 0001)

Marlton, New Jersey, 08053, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • Is in good health before randomization
  • Has body mass index (BMI) between 18 and 32 kg/m^2, inclusive

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • Has history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
  • Has history of cancer (malignancy).
  • Has positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).

Treatment and study plan

MK-8527

Drug

Oral administration

moxifloxacin

Drug

Oral administration

Placebo

Drug

Oral administration

Primary outcomes

  1. Change from Baseline in QT interval corrected for heart rate (QTc) following MK-8527 administration

    Time frame: Baseline and up to approximately 24 hours

    Change from Baseline in QTc following MK-8527 administration will be reported.

Secondary outcomes

  1. Number of participants who experience one or more adverse events (AEs)

    Time frame: Up to approximately 7 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported.

  2. Number of participants who discontinue study intervention due to an AE

    Time frame: Up to approximately 7 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported.

  3. Change from Baseline in QTc following moxifloxacin administration

    Time frame: Baseline and up to approximately 24 hours

    Change from Baseline in QTc following moxifloxacin administration will be reported.

  4. Area Under the Plasma Concentration-Time curve From Time 0 to 24 hours (AUC0-24) of MK-8527

    Time frame: At designated timepoints (up to 24 hours postdose)

    Blood samples will be collected at multiple time points to estimate AUC0-24 of MK-8527

  5. Area Under the Plasma Concentration-Time curve From Time 0 to 168 hours (AUC0-168) of MK-8527

    Time frame: At designated timepoints (up to 168 hours postdose)

    Blood samples will be collected at multiple time points to estimate AUC0-168 of MK-8527

  6. Area Under the Plasma Concentration-Time curve From Time 0 to infinity (AUC0-inf) of MK-8527

    Time frame: At designated timepoints (up to approximately 7 weeks)

    Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527

  7. Maximum plasma concentration (Cmax) of MK-8527

    Time frame: At designated timepoints (up to approximately 7 weeks)

    Blood samples will be collected at multiple time points to estimate Cmax of MK-8527

  8. Time to maximum plasma concentration (Tmax) of MK-8527

    Time frame: At designated timepoints (up to approximately 7 weeks)

    Blood samples will be collected at multiple time points to estimate Tmax of MK-8527

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled and Active-controlled Trial to Evaluate the Effect of a Supratherapeutic Dose of MK-8527 on the QTc Interval in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2025
Registry last updated
Jan 29, 2026

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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