Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-5172 (MK-5172-013)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01390428
First received: July 7, 2011
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

This study will compare the pharmacokinetics (PK) of MK-5172 when administered to participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria of the Child-Pugh's scale) with the PK of MK-5172 when administered to healthy participants.


Condition Intervention Phase
Hepatitis C
Drug: MK-5172
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, 3-Part, Multiple Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-5172

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Area Under the Concentration Time-curve from 0 to 24 hours (AUC0-24) of MK-5172 [ Time Frame: Hour 0 to Hour 24 postdose on Days 1 and 10 ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) of MK-5172 [ Time Frame: Days 1 and 10 ] [ Designated as safety issue: No ]
  • Time to peak concentration (Tmax) of MK-5172 [ Time Frame: Days 1 and 10 ] [ Designated as safety issue: No ]
  • Concentrations 24 hours post-dose (C24) of MK-5172 [ Time Frame: 24 hours postdose on Days 1 and 10 ] [ Designated as safety issue: No ]
  • Apparent terminal half-life (t1/2) of MK-5172 [ Time Frame: Day 10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: July 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1-Mild Hepatic Impairment
Participants with mild hepatic impairment will receive 200 mg of MK-5172 once a day for 10 consecutive days during Part 1 of the study.
Drug: MK-5172
Part 1: oral morning dose of 200 mg daily for 10 days Part 2: oral morning dose of 100 mg daily for 10 days Part 3: oral morning dose of 50 mg daily for 10 days
Experimental: Part 1-Healthy
Healthy participants will receive 200 mg of MK-5172 once a day for 10 consecutive days during Part 1 of the study.
Drug: MK-5172
Part 1: oral morning dose of 200 mg daily for 10 days Part 2: oral morning dose of 100 mg daily for 10 days Part 3: oral morning dose of 50 mg daily for 10 days
Experimental: Part 2-Moderate Hepatic Impairment
Participants with moderate hepatic impairment will receive 100 mg of MK-5172 once a day for 10 consecutive days during Part 2 of the study.
Drug: MK-5172
Part 1: oral morning dose of 200 mg daily for 10 days Part 2: oral morning dose of 100 mg daily for 10 days Part 3: oral morning dose of 50 mg daily for 10 days
Experimental: Part 2-Healthy
Healthy participants will receive 100 mg of MK-5172 once a day for 10 consecutive days during Part 2 of the study.
Drug: MK-5172
Part 1: oral morning dose of 200 mg daily for 10 days Part 2: oral morning dose of 100 mg daily for 10 days Part 3: oral morning dose of 50 mg daily for 10 days
Experimental: Part 3-Severe Hepatic Impairment
Participants with severe hepatic impairment will receive 50 mg of MK-5172 once a day for 10 consecutive days during Part 3 of the study.
Drug: MK-5172
Part 1: oral morning dose of 200 mg daily for 10 days Part 2: oral morning dose of 100 mg daily for 10 days Part 3: oral morning dose of 50 mg daily for 10 days
Experimental: Part 3-Healthy
Healthy participants will receive 50 mg of MK-5172 once a day for 10 consecutive days during Part 3 of the study.
Drug: MK-5172
Part 1: oral morning dose of 200 mg daily for 10 days Part 2: oral morning dose of 100 mg daily for 10 days Part 3: oral morning dose of 50 mg daily for 10 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • If female, must be of non-childbearing potential or willing to use at least 2 acceptable methods of contraception from enrollment to 2 weeks after the last dose of study drug
  • No clinically significant abnormality on electrocardiogram

Hepatic Insufficiency Participants Only:

  • Other than hepatic insufficiency with features of cirrhosis, is otherwise in good health based on medical history, physical examination, vital signs, and laboratory safety tests
  • Chronic (>6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology
  • Score on the Child-Pugh scale must range from 5 to 6 (mild hepatic insufficiency) to from 7 to 9 (moderate hepatic insufficiency) to from 10 to 15 (severe hepatic insufficiency)

Matched Healthy Participants Only:

- In good health based on medical history, physical examination, vital signs, and laboratory safety tests

Exclusion Criteria:

  • History of any illness that might confound the results of the study or poses an additional risk to the participant
  • History of clinically significant endocrine, gastrointestinal (other than related to their hepatic impairment), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
  • Pregnancy
  • Estimated creatinine clearance of ≤60 mL/min
  • History of stroke, chronic seizures, or major neurological disorder
  • History of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment
  • Unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's Wort, green tea, gingko, coenzyme Q, ginseng, echinacea, etc.) or nutritional supplements (e.g., garlic supplements), beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug, throughout the study, until the poststudy visit
  • Participated in another investigational study within 4 weeks
  • History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food

Hepatic Insufficiency Participants Only:

- Has a history of hepatitis C infection by serology, regardless of most recent viral load status.

Matched Healthy Participants Only:

  • History of any chronic and/or active hepatic disease including elevations of serum transaminases, hepatitis, biliary tract disease, or a history of any significant gastrointestinal surgery.
  • History of hepatitis C. Participants with a history of self-limited hepatitis A with complete resolution documented at least 6 months prior to entry will be eligible for inclusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390428

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, Florida
Call for Information (Investigational Site 0003) Recruiting
Orlando, Florida, United States, 32809
United States, Tennessee
Call for Information (Investigational Site 0004) Recruiting
Knoxville, Tennessee, United States, 37920
New Zealand
Merck Sharp & Dohme (New Zealand) Ltd., Recruiting
Wellington, New Zealand
Contact: Gary Jankelowitz    61 2 8988 8246      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01390428     History of Changes
Other Study ID Numbers: 5172-013
Study First Received: July 7, 2011
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on August 20, 2014