A Clinical Trial to Evaluate the Effect of Ulonivirine (MK-8507) on Heart Rhythm in Healthy Adults (MK-8507-012)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Ulonivirine; Drug: Moxifloxacin Placebo; Drug: Ulonivirine Placebo; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07305831

8507-012

MK-8507-012 (Other Identifier)

Details and patient eligibility

About

Researchers are looking for new treatments for HIV-1 (human immunodeficiency virus type 1) that are safe, well-tolerated, and can be taken less often. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system.

Ulonivirine (MK-8507) is a study medicine designed to treat HIV-1

The goal of this study is to learn if ulonivirine does not increase the QT interval (a measure of heart rhythm on an electrocardiogram) above a certain amount. Researchers also want to learn what happens to the amount of ulonivirine in a healthy person's body over time.

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Is in good health before randomization
• Has body Mass Index (BMI) between 18 and 32 kg/m2, inclusive

Exclusion criteria

• Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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62 participants in 2 patient groups

Moxifloxacin 400 mg + Placebo (Arm 1)

Experimental group

Description:

Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR ulonivirine dose matched placebo + moxifloxacin 400 mg.

Treatment:

Drug: Moxifloxacin

Drug: Ulonivirine Placebo

Drug: Moxifloxacin Placebo

Ulonivirine Dose 1 + Placebo (Arm 2)

Experimental group

Description:

Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR moxifloxacin dose matched placebo + ulonivirine Dose 1.

Treatment:

Drug: Ulonivirine Placebo

Drug: Moxifloxacin Placebo

Drug: Ulonivirine