34 Participants Needed

Efavirenz for Healthy Subjects

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Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Merck Sharp & Dohme LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Efavirenz for healthy subjects?

Efavirenz has been effectively used as a key part of HIV treatment since 1996, showing success in both new and experienced patients, and is known for its once-daily dosing that helps with treatment adherence.12345

Is efavirenz generally safe for humans?

Efavirenz has been used safely in many people with HIV, but it can cause side effects related to the brain, like dizziness or trouble sleeping. These effects are not fully understood, but the drug is generally well-tolerated.46789

What makes the drug Efavirenz unique compared to other treatments?

Efavirenz is unique because it is a potent, once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used for HIV treatment, available as a single 600 mg tablet, which simplifies therapy and reduces the number of pills a patient needs to take, potentially improving adherence and treatment outcomes.210111213

What is the purpose of this trial?

The goal of the study is to learn what happens to levels of MK-7602 in a healthy person's body over time. Researchers will compare what happens to MK-7602 in the body when it is given with or without another medicine called efavirenz, and when it is given with or without a meal.

Research Team

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for healthy individuals with a BMI between 18 to 32 kg/m^2. Specific details about who can't join the trial are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

My BMI is between 18 and 32.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MK-7602 with or without efavirenz to study pharmacokinetics

6 weeks
Multiple visits for blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Efavirenz
  • MK-7602
Trial Overview The study investigates how MK-7602 levels change over time in the body of a healthy person when taken alone or combined with another drug called efavirenz. It's designed to understand the interaction between these two substances.
Participant Groups
7Treatment groups
Experimental Treatment
Group I: Part 2, Sequence 6: Low-Fat Meal→Moderate-Fat Meal→FastedExperimental Treatment1 Intervention
Participants will be administered MK-7602 with a low-fat meal, then with a moderate-fat meal, then in the fasted state.
Group II: Part 2, Sequence 5: Low-Fat Meal→Fasted→Moderate-Fat MealExperimental Treatment1 Intervention
Participants will be administered MK-7602 with a low-fat meal, then in the fasted state, then with a moderate-fat meal.
Group III: Part 2, Sequence 4: Moderate-Fat Meal→Fasted→Low-Fat MealExperimental Treatment1 Intervention
Participants will be administered MK-7602 with a moderate-fat meal, then in the fasted state, then with a low-fat meal.
Group IV: Part 2, Sequence 3: Moderate-Fat Meal→Low-Fat Meal→FastedExperimental Treatment1 Intervention
Participants will be administered MK-7602 with a moderate-fat meal, then with a low-fat meal, then in the fasted state.
Group V: Part 2, Sequence 2: Fasted→Low-Fat Meal→Moderate-Fat MealExperimental Treatment1 Intervention
Participants will be administered MK-7602 in the fasted state, then with a low-fat meal, then with a moderate-fat meal.
Group VI: Part 2, Sequence 1: Fasted→Moderate-Fat Meal→Low-Fat MealExperimental Treatment1 Intervention
Participants will be administered MK-7602 in the fasted state, then with a moderate-fat meal, then with a low-fat meal.
Group VII: Part 1: MK-7602 + EfavirenzExperimental Treatment2 Interventions
Participants will be administered MK-7602 and efavirenz.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

Efavirenz, a common medication for HIV type-1, is mainly broken down by the CYP2B6 enzyme, and genetic variations in this enzyme can lead to higher risks of side effects, especially affecting the central nervous system.
Understanding a patient's CYP2B6 genotype can help healthcare providers make better prescribing decisions for efavirenz, potentially reducing the risk of adverse effects and treatment discontinuation.
Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2B6 and Efavirenz-Containing Antiretroviral Therapy.Desta, Z., Gammal, RS., Gong, L., et al.[2021]
Efavirenz has been a key medication in HIV treatment since 1996, showing strong efficacy in both treatment-naïve and treatment-experienced patients, supported by numerous clinical studies.
The introduction of a single 600 mg tablet formulation simplifies the treatment regimen, potentially improving patient adherence and outcomes, while its side effects are generally mild and manageable.
Efavirenz: enhancing the gold standard.Arribas, JR.[2020]
A study involving 235 HIV-positive patients revealed significant interpatient variability in efavirenz levels, suggesting that individual plasma concentration monitoring could optimize dosing and improve treatment outcomes.
The research found a correlation between higher efavirenz exposure and lower viral loads, as well as a potential link to central nervous system toxicity, indicating that careful dosage adjustments could enhance efficacy while minimizing side effects.
Population pharmacokinetics and effects of efavirenz in patients with human immunodeficiency virus infection.Csajka, C., Marzolini, C., Fattinger, K., et al.[2020]

References

Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2B6 and Efavirenz-Containing Antiretroviral Therapy. [2021]
Efavirenz: enhancing the gold standard. [2020]
Population pharmacokinetics and effects of efavirenz in patients with human immunodeficiency virus infection. [2020]
Neuropsychometric correlates of efavirenz pharmacokinetics and pharmacogenetics following a single oral dose. [2021]
Population pharmacokinetic meta-analysis with efavirenz. [2020]
Safety and tolerance of efavirenz in different antiretroviral regimens: results from a national multicenter prospective study in 1,033 HIV-infected patients. [2022]
Efavirenz for HIV-1 infection in adults: an overview. [2020]
Pharmacokinetic and Pharmacodynamic Comparison of Once-Daily Efavirenz (400 mg vs. 600 mg) in Treatment-Naïve HIV-Infected Patients: Results of the ENCORE1 Study. [2022]
Comprehensive Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Evaluation of Once-Daily Efavirenz 400 and 600 mg in Treatment-Naïve HIV-Infected Patients at 96 Weeks: Results of the ENCORE1 Study. [2022]
Comparative bioavailability of a generic capsule formulation of the reverse transcriptase inhibitor efavirenz and the innovator product. [2020]
Simple and rapid liquid chromatography method for determination of efavirenz in plasma. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Population Approach to Efavirenz Therapy. [2020]
Quantitative determination of efavirenz (DMP 266), a novel non-nucleoside reverse transcriptase inhibitor, in human plasma using isocratic reversed-phase high-performance liquid chromatography with ultraviolet detection. [2020]
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