A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1)
2 other identifiers
interventional
30
0 countries
N/A
Brief Summary
This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts. Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part II will enroll genotype 3 (GT3) HCV-infected participants. Both Parts may run concurrently or may be staggered.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 4, 2012
CompletedFirst Posted
Study publicly available on registry
May 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJanuary 22, 2015
January 1, 2015
9 months
May 4, 2012
January 21, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT1 HCV-infected participants
Predose on Day 1 through Day 56
Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT3 HCV-infected participants
Predose on Day 1 through Day 56
Number of participants experiencing clinical or laboratory adverse events (AEs)
From first dose up to 21 days
Number of participants discontinued from study treatment due to AEs
From Day 1 through Day 7
Secondary Outcomes (2)
Area under the plasma concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-2748
Day 1 and Day 7, predose through 24 hours post-dose
Plasma concentration of MK-2748 (C24) on Day 7 of dosing
24 hours post-dose on Day 7
Study Arms (10)
Panel A: GT1, low dose
EXPERIMENTALParticipants with genotype 1 (GT1) Hepatitis C Virus (HCV) will receive low dose MK-2748 daily for 7 days.
Panel B: GT1, lower dose
EXPERIMENTALParticipants with GT1 HCV will receive lower dose MK-2748 daily for 7 days.
Panel C: GT1, dose based on Panels A+B
EXPERIMENTALParticipants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose) and B (lower dose).
Panel G: GT1, dose based on Panels A+B+C
EXPERIMENTALParticipants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), and C.
Panel H: GT1, dose based on Panels A+B+C+G
EXPERIMENTALParticipants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), C, and G.
Panel D: GT3, low dose (Omitted)
EXPERIMENTALParticipants with genotype 3 (GT3) HCV were to receive low dose MK-2748 daily for 7 days. Panel D was omitted from the study design and participants were not enrolled in this panel.
Panel E: GT3, high dose
EXPERIMENTALParticipants with genotype 3 (GT3) HCV will receive high dose MK-2748 daily for 7 days.
Panel F: GT3, dose based on Panel E
EXPERIMENTALParticipants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panel E (high dose).
Panel I: GT3, dose based on Panels E+F
EXPERIMENTALParticipants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose) and F.
Panel J: GT3, dose based on Panels E+F+I
EXPERIMENTALParticipants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose), F, and I.
Interventions
MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment
Placebo tablets, orally, once daily for 7 days
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of chronic HCV infection (GT1 or GT3) for at least 6 months and detectable HCV-RNA in peripheral blood
- Body mass index (BMI) of 18 to 37 kg/m\^2
- No clinically significant abnormality on electrocardiogram (ECG)
- Stable health
- Willing to use appropriate contraception throughout the study and for 90 days after last dose of study drug
You may not qualify if:
- Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
- History of stroke, chronic seizures, or major neurological disorder
- History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- History of neoplastic disease (exceptions of adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, or other malignancies which have been successfully treated ≥10 years prior and unlikely to recur
- Positive Hepatitis B surface antigen
- Documented human immunodeficiency virus (HIV) infection
- 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
- Consumption of excessive amounts, 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, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to study enrollment
- 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
- Current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months prior to enrollment
- 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 treatment with other HCV NS3/4A protease inhibitors
- Previous exposure to interferon-alpha and/or ribavirin within 3 months prior to study enrollment
- Clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3)
- +1 more criteria
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
May 4, 2012
First Posted
May 8, 2012
Study Start
May 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
January 22, 2015
Record last verified: 2015-01