A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1972 in HIV-1 Infected Patients
Overview
- Phase
- Phase 1
- Intervention
- MK-1972
- Conditions
- HIV-1 Infection
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 12
- Primary Endpoint
- Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a two part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-1972 in participants with HIV-1 infections. In Part 1, participants will be randomized to receive MK-1972 (at one of 5 different dose levels given once or twice per day) or placebo. Part II will begin after the results of Part I are known; participants will be randomized to receive MK-1972 (only one dose level, twice per day) or placebo. The primary hypotheses are that MK-1972 at the studied doses is safe and well tolerated in HIV-1 infected males; and that MK-1972 has superior antiretroviral activity compared to placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
MK-1972 50 mg once daily (Part I)
Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
Intervention: MK-1972
MK-1972 50 mg once daily (Part I)
Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
Intervention: Placebo to MK-1972
MK-1972 200 mg once daily (Part I)
Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
Intervention: MK-1972
MK-1972 200 mg once daily (Part I)
Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
Intervention: Placebo to MK-1972
MK-1972 800 mg once daily (Part I)
Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
Intervention: MK-1972
MK-1972 800 mg once daily (Part I)
Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
Intervention: Placebo to MK-1972
MK-1972 25 mg twice daily (Part I)
Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
Intervention: MK-1972
MK-1972 25 mg twice daily (Part I)
Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
Intervention: Placebo to MK-1972
MK-1972 100 mg twice daily (Part I)
Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
Intervention: MK-1972
MK-1972 100 mg twice daily (Part I)
Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
Intervention: Placebo to MK-1972
Placebo twice daily (Part I)
Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
Intervention: Placebo to MK-1972
MK-1972 800 mg twice daily (Part II)
Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part II)
Intervention: MK-1972
MK-1972 800 mg twice daily (Part II)
Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part II)
Intervention: Placebo to MK-1972
Placebo twice daily (Part II)
Ten capsules containing placebo were taken orally, twice per day for 10 days (Part II)
Intervention: Placebo to MK-1972
Outcomes
Primary Outcomes
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)
Time Frame: From consent to 14 days after the last dose (up to Day 24)
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an adverse event.
Change From Baseline to Day 10 in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Due to Treatment With MK-1972 or Placebo
Time Frame: Baseline and Day 10 (24 hours post-dose)
Blood was collected at baseline and on Day 10, and the plasma concentration for HIV-1 RNA was determined using the Abbott RealTime HIV assay.
Secondary Outcomes
- The Area Under the Curve From 0-24 Hours (AUC0-24hrs) on Day 10 for Plasma Concentration of MK-1972 in Participants With HIV-1 Infection(Day 10: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose)