Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-04-02 @ 4:05 AM
Study NCT ID:
NCT01593735
Status:
COMPLETED
Last Update Posted:
2015-01-22
First Post:
2012-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Lithuania', 'Moldova']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603531', 'term': 'MK-2748'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-21', 'studyFirstSubmitDate': '2012-05-04', 'studyFirstSubmitQcDate': '2012-05-04', 'lastUpdatePostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT1 HCV-infected participants', 'timeFrame': 'Predose on Day 1 through Day 56'}, {'measure': 'Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT3 HCV-infected participants', 'timeFrame': 'Predose on Day 1 through Day 56'}, {'measure': 'Number of participants experiencing clinical or laboratory adverse events (AEs)', 'timeFrame': 'From first dose up to 21 days'}, {'measure': 'Number of participants discontinued from study treatment due to AEs', 'timeFrame': 'From Day 1 through Day 7'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-2748', 'timeFrame': 'Day 1 and Day 7, predose through 24 hours post-dose'}, {'measure': 'Plasma concentration of MK-2748 (C24) on Day 7 of dosing', 'timeFrame': '24 hours post-dose on Day 7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Clinical diagnosis of chronic HCV infection (GT1 or GT3) for at least 6 months and detectable HCV-RNA in peripheral blood\n* Body mass index (BMI) of 18 to 37 kg/m\\^2\n* No clinically significant abnormality on electrocardiogram (ECG)\n* Stable health\n* Willing to use appropriate contraception throughout the study and for 90 days after last dose of study drug\n\nExclusion criteria:\n\n* Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study\n* History of stroke, chronic seizures, or major neurological disorder\n* History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases\n* 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\n* Positive Hepatitis B surface antigen\n* Documented human immunodeficiency virus (HIV) infection\n* 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\n* 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\n* Major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to study enrollment\n* 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\n* Current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months prior to enrollment\n* 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\n* Previous treatment with other HCV NS3/4A protease inhibitors\n* Previous exposure to interferon-alpha and/or ribavirin within 3 months prior to study enrollment\n* Clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3)\n* Participation in another investigational study within 4 weeks prior to enrollment'}, 'identificationModule': {'nctId': 'NCT01593735', 'briefTitle': 'A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2748 in Hepatitis C-Infected Participants', 'orgStudyIdInfo': {'id': '2748-002'}, 'secondaryIdInfos': [{'id': '2011-006296-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel A: GT1, low dose', 'description': 'Participants with genotype 1 (GT1) Hepatitis C Virus (HCV) will receive low dose MK-2748 daily for 7 days.', 'interventionNames': ['Drug: MK-2748', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel B: GT1, lower dose', 'description': 'Participants with GT1 HCV will receive lower dose MK-2748 daily for 7 days.', 'interventionNames': ['Drug: MK-2748', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel C: GT1, dose based on Panels A+B', 'description': 'Participants 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).', 'interventionNames': ['Drug: MK-2748', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel G: GT1, dose based on Panels A+B+C', 'description': 'Participants 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.', 'interventionNames': ['Drug: MK-2748', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel H: GT1, dose based on Panels A+B+C+G', 'description': 'Participants 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.', 'interventionNames': ['Drug: MK-2748', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel D: GT3, low dose (Omitted)', 'description': 'Participants 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.', 'interventionNames': ['Drug: MK-2748', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel E: GT3, high dose', 'description': 'Participants with genotype 3 (GT3) HCV will receive high dose MK-2748 daily for 7 days.', 'interventionNames': ['Drug: MK-2748', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel F: GT3, dose based on Panel E', 'description': 'Participants 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).', 'interventionNames': ['Drug: MK-2748', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel I: GT3, dose based on Panels E+F', 'description': 'Participants 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.', 'interventionNames': ['Drug: MK-2748', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel J: GT3, dose based on Panels E+F+I', 'description': 'Participants 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.', 'interventionNames': ['Drug: MK-2748', 'Drug: Placebo']}], 'interventions': [{'name': 'MK-2748', 'type': 'DRUG', 'description': 'MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment', 'armGroupLabels': ['Panel A: GT1, low dose', 'Panel B: GT1, lower dose', 'Panel C: GT1, dose based on Panels A+B', 'Panel D: GT3, low dose (Omitted)', 'Panel E: GT3, high dose', 'Panel F: GT3, dose based on Panel E', 'Panel G: GT1, dose based on Panels A+B+C', 'Panel H: GT1, dose based on Panels A+B+C+G', 'Panel I: GT3, dose based on Panels E+F', 'Panel J: GT3, dose based on Panels E+F+I']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets, orally, once daily for 7 days', 'armGroupLabels': ['Panel A: GT1, low dose', 'Panel B: GT1, lower dose', 'Panel C: GT1, dose based on Panels A+B', 'Panel D: GT3, low dose (Omitted)', 'Panel E: GT3, high dose', 'Panel F: GT3, dose based on Panel E', 'Panel G: GT1, dose based on Panels A+B+C', 'Panel H: GT1, dose based on Panels A+B+C+G', 'Panel I: GT3, dose based on Panels E+F', 'Panel J: GT3, dose based on Panels E+F+I']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}