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

NCT01329913 | Completed Phase 1

• 2 other identifiers: 6325-0032010-023687-40
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Viral load reduction in GT1 HCV-infected participants (Part I)

  7 Days

• Viral load reduction in GT3 HCV-infected participants (Part II)

  7 Days

Study Arms (6)

GT1-HCV 200 mg

EXPERIMENTAL

Drug: MK-6325; Drug: Placebo to MK-6325

GT1-HCV 400 mg

EXPERIMENTAL

Drug: MK-6325; Drug: Placebo to MK-6325

GTI-HCV 800 mg

EXPERIMENTAL

Drug: MK-6325; Drug: Placebo to MK-6325

GT3-HCV 200 mg

EXPERIMENTAL

Drug: MK-6325; Drug: Placebo to MK-6325

GT3-HCV 400 mg

EXPERIMENTAL

Drug: MK-6325; Drug: Placebo to MK-6325

GT3-HCV 800 mg

EXPERIMENTAL

Drug: MK-6325; Drug: Placebo to MK-6325

Interventions

MK-6325 DRUG

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

GT1-HCV 200 mg; GT3-HCV 200 mg

Placebo to MK-6325 DRUG

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

GT1-HCV 200 mg; GT3-HCV 200 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

MK-6325

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 6, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: February 5, 2015

Record last verified: 2015-02