Skip to main content
OpenTrials
Completed

NCT Number: NCT01593735

A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1)

This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts. Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part II will enroll genotype 3 (GT3) HCV-infected participants. Both Parts may run concurrently or may be staggered.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of chronic HCV infection (GT1 or GT3) for at least 6 months and detectable HCV-RNA in peripheral blood
  • Body mass index (BMI) of 18 to 37 kg/m^2
  • No clinically significant abnormality on electrocardiogram (ECG)
  • Stable health
  • Willing to use appropriate contraception throughout the study and for 90 days after last dose of study drug

Exclusion criteria

  • Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
  • History of stroke, chronic seizures, or major neurological disorder
  • History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
  • History of neoplastic disease (exceptions of adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, or other malignancies which have been successfully treated ≥10 years prior and unlikely to recur
  • Positive Hepatitis B surface antigen
  • Documented human immunodeficiency virus (HIV) infection
  • Consumption of excessive amounts of alcohol, defined as greater than 2 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces],wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
  • Consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) or coffee, tea, cola, or other caffeinated beverages per day
  • Major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to study enrollment
  • History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
  • Current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months prior to enrollment
  • Evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug induced hepatitis, autoimmune hepatitis
  • Previous treatment with other HCV NS3/4A protease inhibitors
  • Previous exposure to interferon-alpha and/or ribavirin within 3 months prior to study enrollment
  • Clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3)
  • Participation in another investigational study within 4 weeks prior to enrollment

Treatment and study plan

MK-2748

Drug

MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment

Placebo

Drug

Placebo tablets, orally, once daily for 7 days

Primary outcomes

  1. Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT1 HCV-infected participants

    Time frame: Predose on Day 1 through Day 56

  2. Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT3 HCV-infected participants

    Time frame: Predose on Day 1 through Day 56

  3. Number of participants experiencing clinical or laboratory adverse events (AEs)

    Time frame: From first dose up to 21 days

  4. Number of participants discontinued from study treatment due to AEs

    Time frame: From Day 1 through Day 7

Secondary outcomes

  1. Area under the plasma concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-2748

    Time frame: Day 1 and Day 7, predose through 24 hours post-dose

  2. Plasma concentration of MK-2748 (C24) on Day 7 of dosing

    Time frame: 24 hours post-dose on Day 7

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2748 in Hepatitis C-Infected Participants

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 8, 2012
Registry last updated
Jan 22, 2015

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.

Published trials that share one or more normalized conditions with this study.