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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02269059
• Date of registration: 16/10/2014
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)
• Scientific title: A Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MK-7680 in Patients With Hepatitis C Infection
• Date of first enrolment: December 2014
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02269059
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Belgium, Moldova, Republic of

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis C

Intervention(s)

Drug: MK-7680

Primary Outcome(s)

Number of participants discontinuing from study therapy due to AEs [Time Frame: Up to 7 days]

Number of participants experiencing an adverse event (AE) [Time Frame: Up to 21 days]

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]

Secondary ID(s)

2014-003674-16

7680-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors