Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections (MK-6325-003)

A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-6325 in Hepatitis C Infected Male and Female Patients

Sponsors

Lead Sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
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.

Overall Status Completed
Start Date May 2011
Completion Date April 2012
Primary Completion Date April 2012
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of participants experiencing clinical and laboratory adverse events (AEs) (Parts I and II) Up to 15 days after last dose of study drug
Secondary Outcome
Measure Time Frame
Viral load reduction in GT1 HCV-infected participants (Part I) 7 Days
Viral load reduction in GT3 HCV-infected participants (Part II) 7 Days
Enrollment 36
Condition
Intervention

Intervention Type: Drug

Intervention Name: MK-6325

Description: Two 100 mg capsules, orally, once per day for 7 days

Intervention Type: Drug

Intervention Name: Placebo to MK-6325

Description: Two 100 mg capsules, orally, once per day for 7 days

Intervention Type: Drug

Intervention Name: MK-6325

Description: Four 100 mg capsules, orally, once per day for 7 days

Intervention Type: Drug

Intervention Name: Placebo to MK-6325

Description: Four 100 mg capsules, orally, once per day for 7 days

Intervention Type: Drug

Intervention Name: MK-6325

Description: Eight 100 mg capsules, orally, once per day for 7 days

Intervention Type: Drug

Intervention Name: Placebo to MK-6325

Description: Eight 100 mg capsules, orally, once per day for 7 days

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Verification Date

February 2015

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 6
Arm Group

Label: GT1-HCV 200 mg

Type: Experimental

Label: GT1-HCV 400 mg

Type: Experimental

Label: GTI-HCV 800 mg

Type: Experimental

Label: GT3-HCV 200 mg

Type: Experimental

Label: GT3-HCV 400 mg

Type: Experimental

Label: GT3-HCV 800 mg

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov