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

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

MK-7680

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GT1 Participants

GT3 Participants

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in HCV viral load

Number of participants experiencing an adverse event (AE)

Number of participants discontinuing from study therapy due to AEs

Secondary Outcome Measures

Full Information

NCT ID

NCT02269059

First Posted

October 16, 2014

Last Updated

July 24, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02269059

Brief Title

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

Official Title

A Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MK-7680 in Patients With Hepatitis C Infection

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GT1 Participants

Arm Type

Experimental

Arm Description

Arm Title

GT3 Participants

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

MK-7680

Intervention Description

MK-7680 10 mg and 100 mg capsules

Primary Outcome Measure Information:

Title

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

Title

Number of participants experiencing an adverse event (AE)

Time Frame

Up to 21 days

Title

Number of participants discontinuing from study therapy due to AEs

Time Frame

Up to 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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