A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C-Infected Males (MK-8325-002 AM1)
This study has suspended participant recruitment.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01554189
First received: March 12, 2012
Last updated: March 1, 2013
Last verified: March 2013
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Purpose
This study is being done to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-8325 in male hepatitis C virus (HCV)-infected participants. There will be 3 parts to this study. Part I will enroll only genotype 1 (GT1) HCV patients, Part II will enroll only genotype 3 (GT3) HCV-infected participants, and Part III will enroll only GT1a HCV-infected participants. All parts may run concurrently, or may be staggered as needed by the clinical sites.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: MK-8325 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C Infected Males |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Change from baseline to Day 5 in plasma HCV ribonucleic acid (RNA) in GT1 participants [ Time Frame: Day 1 predose and 2, 4, 8, 12, 24 and 36 hours post-dose, Days 3 and 4 predose, Day 5 predose and 2, 4, 8, 12, and 24 hours post-dose. ] [ Designated as safety issue: No ]
- Mean maximum reduction from baseline through Day 5 in HCV ribonucleic acid (RNA) in GT3 participants [ Time Frame: Day 1 predose and 2, 4, 8, 12, 24 and 36 hours post-dose, Days 3 and 4 predose, Day 5 predose and 2, 4, 8, 12, and 24 hours post-dose. ] [ Designated as safety issue: No ]
- Number of participants experiencing at least one adverse event [ Time Frame: Day 1 up to 56 days ] [ Designated as safety issue: Yes ]
- Number of participants discontinuing study drug due to an adverse event [ Time Frame: Days 1-5 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Trough plasma concentration (C24hr) of MK-8325 [ Time Frame: Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16, 24, 36,48, 72, 96, 120, 144, 168, 192, 216, and 240 hours post-dose ] [ Designated as safety issue: No ]
- Area under the concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-8325 [ Time Frame: Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose ] [ Designated as safety issue: No ]
- Maximum plasma concentration (Cmax) of MK-8325 [ Time Frame: Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16, 24, 36,48, 72, 96, 120, 144, 168, 192, 216, and 240 hours post-dose ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Panel A (GT1 10 mg) |
Drug: MK-8325
MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
|
| Experimental: Panel B (GT1 50 mg) |
Drug: MK-8325
MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
|
| Experimental: Panel C (GT1 100 mg) |
Drug: MK-8325
MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
|
| Experimental: Panel D (GT1 200 mg) |
Drug: MK-8325
MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
|
| Experimental: Panel E (GT3 10 mg) |
Drug: MK-8325
MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
|
| Experimental: Panel F (GT3 50 mg) |
Drug: MK-8325
MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
|
| Experimental: Panel G (GT3 100 mg) |
Drug: MK-8325
MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
|
| Experimental: Panel H (GT3 200 mg) |
Drug: MK-8325
MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
|
| Experimental: Panel I (GT1a 10 mg) |
Drug: MK-8325
MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
|
| Experimental: Panel J (GT1a 50 mg) |
Drug: MK-8325
MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
|
| Placebo Comparator: Placebo Panel |
Drug: Placebo
Placebo to match MK-8325 capsules, orally, once per day for 5 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Body mass index (BMI) of 18 to ≤37 kg/m^2
- Diagnosis of chronic HCV infection
- Must be infected with HCV GT1a, GT1b, or GT3
Exclusion criteria:
- Co-infection with GT1 and GT3 HCV
- History of stroke, chronic seizures, or major neurological disorder
- History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- History of neoplastic disease
- Positive Hepatitis B surface antigen
- History of human immunodeficiency virus (HIV) infection or positive HIV serology
- Major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior
- History of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- Current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months
- 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
- Previous treatments(s) with nonstructural 5A (NS5A) protein inhibitors
- Treatment with protease inhibitor(s) <30 days prior to study enrollment
- Previous exposure to interferon-alpha and/or ribavirin within 3 months prior to the first dose of MK-8325 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01554189 History of Changes |
| Other Study ID Numbers: | 8325-002, 2011-006263-22 |
| Study First Received: | March 12, 2012 |
| Last Updated: | March 1, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hepatitis, Chronic |
ClinicalTrials.gov processed this record on May 19, 2013