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Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)

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ClinicalTrials.gov Identifier: NCT02269059
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This is a two-part dose-finding trial of MK-7680 in participants with Hepatitis C Virus (HCV) infection of genotype (GT)1 (Part I) and GT3 (Part 2). The primary hypothesis is that daily administration of a safe and well tolerated dose of MK-7680 will produce a decrease in HCV viral load.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: MK-7680 Phase 1

Detailed Description:
Parts 1 and 2 will each consist of 4 panels. In the first panel, a 200 mg dose of MK-7680 will be administered. In each of the following 3 panels, higher or lower doses of MK-7680 will be administered. Each panel will only begin once the safety and tolerability data from the preceding panel have been evaluated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MK-7680 in Patients With Hepatitis C Infection
Study Start Date : December 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GT1 Participants
Participants take MK-7680 capsules by mouth once daily (QD) for 7 days. The starting dose will be 200 mg and the dose will be adjusted in successive panels of participants based on analysis of results of the previous panel.
Drug: MK-7680
MK-7680 10 mg and 100 mg capsules

Experimental: GT3 Participants
Participants take MK-7680 capsules by mouth QD for 7 days. The starting dose will be 200 mg and the dose will be adjusted in successive panels of participants based on analysis of results of the previous panel.
Drug: MK-7680
MK-7680 10 mg and 100 mg capsules




Primary Outcome Measures :
  1. Change from baseline in HCV viral load [ Time Frame: Day 1: predose, 2, 4, 8, 12, and 24 hours postdose; Days 3, 4, 5, and 6: predose; and Day 7: predose, 4, 12, 24, and 48 hours postdose ]
  2. Number of participants experiencing an adverse event (AE) [ Time Frame: Up to 21 days ]
  3. Number of participants discontinuing from study therapy due to AEs [ Time Frame: Up to 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is in good health except for HCV infection
  • Is male or is a female of non-childbearing potential
  • Clinical diagnosis of HCV GT1 or GT3 with no evidence of mixed-GT or non-typeable infection

Exclusion Criteria:

  • Has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary, or major neurological abnormality or disease
  • Has a history of cancer
  • Has a history of significant multiple and/or severe allergies
  • Is positive for hepatitis B or human immunodeficiency virus
  • Has had major surgery, donated or lost 1 unit (500 mL) of blood within 4 weeks prior to screening
  • Consumes more than 2 alcoholic beverages per day or is currently a regular user of any illicit drug(s) or has a history of alcohol/drug abuse within 12 months prior to screening
  • Has chronic hepatitis not caused by HCV (e.g., nonalcoholic steatohepatitis [NASH])
  • Has clinical or laboratory evidence of advanced or decompensated liver disease, or evidence of bridging or higher grade fibrosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269059


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02269059     History of Changes
Other Study ID Numbers: 7680-003
2014-003674-16 ( EudraCT Number )
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections