A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C-Infected Males (MK-8325-002)
A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C Infected Males
2 other identifiers
interventional
37
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2012
CompletedFirst Posted
Study publicly available on registry
March 14, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJuly 21, 2015
July 1, 2015
1 year
March 12, 2012
July 20, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Change from baseline to Day 5 in plasma HCV ribonucleic acid (RNA) in GT1 participants
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.
Mean maximum reduction from baseline through Day 5 in HCV ribonucleic acid (RNA) in GT3 participants
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.
Number of participants experiencing at least one adverse event
Day 1 up to 56 days
Number of participants discontinuing study drug due to an adverse event
Days 1-5
Secondary Outcomes (3)
Trough plasma concentration (C24hr) of MK-8325
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
Area under the concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-8325
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
Maximum plasma concentration (Cmax) of MK-8325
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
Study Arms (11)
Panel A (GT1 10 mg)
EXPERIMENTALPanel B (GT1 50 mg)
EXPERIMENTALPanel C (GT1 100 mg)
EXPERIMENTALPanel D (GT1 200 mg)
EXPERIMENTALPanel E (GT3 10 mg)
EXPERIMENTALPanel F (GT3 50 mg)
EXPERIMENTALPanel G (GT3 100 mg)
EXPERIMENTALPanel H (GT3 200 mg)
EXPERIMENTALPanel I (GT1a 10 mg)
EXPERIMENTALPanel J (GT1a 50 mg)
EXPERIMENTALPlacebo Panel
PLACEBO COMPARATORInterventions
MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2012
First Posted
March 14, 2012
Study Start
April 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
July 21, 2015
Record last verified: 2015-07