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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329913
• Other study ID #: 6325-003
• Secondary ID: 2010-023687-40
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2011
• Last updated: February 4, 2015
• Start date: May 2011
• Est. completion date: April 2012

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• MK-6325
Two 100 mg capsules, orally, once per day for 7 days
• Placebo to MK-6325
Two 100 mg capsules, orally, once per day for 7 days
• MK-6325
Four 100 mg capsules, orally, once per day for 7 days
• Placebo to MK-6325
Four 100 mg capsules, orally, once per day for 7 days
• MK-6325
Eight 100 mg capsules, orally, once per day for 7 days
• Placebo to MK-6325
Eight 100 mg capsules, orally, once per day for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing clinical and laboratory adverse events (AEs) (Parts I and II)		Up to 15 days after last dose of study drug	Yes
Secondary	Viral load reduction in GT1 HCV-infected participants (Part I)		7 Days	No
Secondary	Viral load reduction in GT3 HCV-infected participants (Part II)		7 Days	No