Clinical trial NCT01329913: Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections (MK-6325-003)
Official title: A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-6325 in Hepatitis C Infected Male and Female Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-04-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of MK-6325 in HCV-infected participants. Part I of the study will be for Genotype (GT) 1 HCV-infected participants who will be randomized to receive either MK-6325 or placebo. If the drug is shown to be safe and efficacious in Part I, Part II will enroll GT 3 HCV-infected participants who will be randomized to receive either MK-6325 or placebo.


Eligibility criteria: Inclusion criteria:

* Body mass index (BMI) of 18 to ≤37 kg/m\^2.
* Stable health
* No clinically significant abnormality on electrocardiogram (ECG)
* Clinical diagnosis of chronic HCV infection (G1 or G3) for at least 6 months and detectable HCV RNA in peripheral blood.

Exclusion criteria:

* Pregnancy or intention to become pregnant or father a child during the course of the study.
* History of stroke, chronic seizures, major neurological disorder, or uncontrolled clinically significant psychiatric disorder (for example, depression).
* Estimated creatinine clearance of ≤70 mL/min.
* History of clinically significant endocrine, gastrointestinal (except HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases whose current condition is considered clinically unstable.
* History of neoplastic disease other than adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix ≥10 years prior to the prestudy (screening) visit with no evidence of recurrence of likelihood of recurrence.
* Positive Hepatitis B surface antigen at the pre-study (screening) visit.
* History of documented HIV infection or positive HIV serology at the pre-study (screening) visit.
* Regular 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.
* Excessive consumption, 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, or donation or loss of 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit.
* 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.
* Regular use of (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 months. Exception: marijuana use is permitted at the discretion of the investigator and provided the participant can refrain from its use during the study.
* 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. Note: Participants with history of acute non-HCV-related hepatitis, which resolved \>6 months before study can be enrolled.
* Previous treatment with other HCV protease inhibitors ≤3 months prior to the first dose of study drug.
* Previous exposure to interferon-alpha and/or ribavirin within 3 month prior to the first dose of MK-6325 in the study.
* Clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior liver biopsy. Note: liver biopsy is not required for entry into the study.

Primary outcomes:
measure: Number of participants experiencing clinical and laboratory adverse events (AEs) (Parts I and II)
timeFrame: Up to 15 days after last dose of study drug
Secondary outcomes:
measure: Viral load reduction in GT1 HCV-infected participants (Part I)
timeFrame: 7 Days
measure: Viral load reduction in GT3 HCV-infected participants (Part II)
timeFrame: 7 Days
Other outcomes:
Locations:
Study officials:
References: