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CompletedNCT01329913Updated Feb 5, 2015

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

A Phase 1 interventional study of MK-6325 and Placebo to MK-6325 in Hepatitis C, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-02-05.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 36 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
36 participants (actual)

Study arms

  • Experimental
    GT1-HCV 200 mg

    Drug: MK-6325 · Drug: Placebo to MK-6325

  • Experimental
    GT1-HCV 400 mg

    Drug: MK-6325 · Drug: Placebo to MK-6325

  • Experimental
    GTI-HCV 800 mg

    Drug: MK-6325 · Drug: Placebo to MK-6325

  • Experimental
    GT3-HCV 200 mg

    Drug: MK-6325 · Drug: Placebo to MK-6325

  • Experimental
    GT3-HCV 400 mg

    Drug: MK-6325 · Drug: Placebo to MK-6325

  • Experimental
    GT3-HCV 800 mg

    Drug: MK-6325 · Drug: Placebo to MK-6325

Interventions

  • DrugMK-6325

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

  • DrugPlacebo to MK-6325

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

  • DrugMK-6325

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

  • DrugPlacebo to MK-6325

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

  • DrugMK-6325

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

  • DrugPlacebo to MK-6325

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

06

What researchers measure

Primary outcomes

  1. Number of participants experiencing clinical and laboratory adverse events (AEs) (Parts I and II)

    Time frame: Up to 15 days after last dose of study drug

Secondary outcomes

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

    Time frame: 7 Days

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

    Time frame: 7 Days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01329913
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Apr 6, 2011
Start date
May 2011
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Feb 5, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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