Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002)

NCT ID: NCT03188523

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-08
• Study Completion Date: 2018-06-04

Brief Summary

This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-retroviral therapy (ART) activity of monotherapy with MK-8504 (a tenofovir pro-drug), in ART-naïve Human Immunodeficiency Virus (HIV)-1 infected participants. The primary hypothesis is that MK-8504, at a dose that is sufficiently safe and well tolerated, has superior antiretroviral activity compared to placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours post-dose.

Conditions

HIV-1 Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK-8504 100 mg (Panel A)

Participants receive a single oral dose of MK-8504 100 mg.

Group Type: EXPERIMENTAL

MK-8504

Intervention Type: DRUG

After at least an 8-hour fast, a single oral dose of MK-8504 will be administered in capsule form.

MK-8504 240 mg (Panel B)

Participants receive a single oral dose of MK-8504 240 mg.

Group Type: EXPERIMENTAL

MK-8504

Intervention Type: DRUG

After at least an 8-hour fast, a single oral dose of MK-8504 will be administered in capsule form.

MK-8504 ≤240 mg (Panel C)

Participants receive a single oral dose of MK-8504 ≤240 mg.

Group Type: EXPERIMENTAL

MK-8504

Intervention Type: DRUG

After at least an 8-hour fast, a single oral dose of MK-8504 will be administered in capsule form.

MK-8504 ≤240 mg (Panel D)

Participants receive a single oral dose of MK-8504 ≤240 mg.

Group Type: EXPERIMENTAL

MK-8504

Intervention Type: DRUG

After at least an 8-hour fast, a single oral dose of MK-8504 will be administered in capsule form.

Interventions

MK-8504

After at least an 8-hour fast, a single oral dose of MK-8504 will be administered in capsule form.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or non-pregnant and non-breast feeding female
• Have a Body Mass Index (BMI) ≤35 kg/m^2
• Other than HIV infection, have stable baseline health based on medical history, physical examination, vital sign measurements, and laboratory safety test
• Is documented HIV-1 positive
• Is diagnosed with HIV-1 infection 3 months prior to screening
• Is ART-naïve
• Has not received an investigational agent or marketed ART within 30 days of study drug administration and is willing to receive no other ART for the duration of this study
• Agree to follow smoking and other trial restrictions

Exclusion Criteria

• Is mentally or legally institutionalized / incapacitated, has significant emotional problems at the time of pretrial (screening) visit or expected during the conduct of the trial or has a history of clinically significant psychiatric disorder of the last 5 years
• Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Has a history of cancer (malignancy)
• Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food
• Is positive for hepatitis B surface antigen
• Has a history of chronic Hepatitis C
• Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit.
• Has participated in another investigational trial within 4 weeks or 5 half-lives, whichever is greater, prior to the Day 1 Dosing visit
• Is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of trial drug, throughout the trial, until the post-trial visit
• Consumes greater than 3 glasses of alcoholic beverages or distilled spirits per day
• Consumes excessive amounts, defined as greater than 6 servings of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day
• Is an excessive smoker (i.e., more than 10 cigarettes/day) and is unwilling to restrict smoking to ≤10 cigarettes per day
• Have clinically significant abnormality on the electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
• Has a positive urine drug screen (except for cannabis) at screening and/or predose, rechecks are allowed

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Charite Research Organisation GmbH. ( Site 0002)

Berlin, , Germany

St Stephen's Clinical Research ( Site 0001)

London, , United Kingdom

Countries

Germany; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-000998-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-8504-002

Identifier Type: OTHER

Identifier Source: secondary_id

8504-002

Identifier Type: -

Identifier Source: org_study_id