A Multiple Dose Study of MK-5172 in Hepatitis C-Infected Participants (MK-5172-010 AM1)

This study is not yet open for participant recruitment.

Verified May 2013 by Merck

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01537900

First received: February 17, 2012

Last updated: May 17, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 17, 2012
Last Updated Date	May 17, 2013
Start Date ^ICMJE	July 2013
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 17, 2012)	Area under the concentration versus time curve (AUC) for MK-5172 in the liver over 24 hours (AUC[H,0-24 hr]) and the plasma (AUC[0-24 hr]) [ Time Frame: Over 24 hours post-dose on Day 7 ] [ Designated as safety issue: No ] Geometric mean ratio (GMR) of MK-5172 in the liver and the plasma at 4 hours post dose [ Time Frame: 4 hours post-dose on Day 7 ] [ Designated as safety issue: No ] GMR of MK-5172 in the liver and the plasma at 8 hours post dose [ Time Frame: 8 hours post-dose on Day 7 ] [ Designated as safety issue: No ] GMR of MK-5172 in the liver and the plasma at 12 hours post dose [ Time Frame: 12 hours post-dose on Day 7 ] [ Designated as safety issue: No ] GMR of MK-5172 in the liver and the plasma at 24 hours post dose [ Time Frame: 24 hours post-dose on Day 7 ] [ Designated as safety issue: No ] Apparent terminal half life (t½ ) of MK-5172 in the liver (t[H]½) and the plasma (t½) [ Time Frame: Assessed at time of liver biopsy (4, 8, 12, or 24 hours post-dose on Day 7) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01537900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 17, 2012)	Maximum concentration (Cmax) of MK-5172 in the plasma [ Time Frame: Predose to 24 hours post-dose on Day 7 ] [ Designated as safety issue: No ] Lowest concentration (Ctrough) of MK-5172 in the plasma [ Time Frame: Predose to 24 hours post-dose on Day 7 ] [ Designated as safety issue: No ] Time to maximum concentration (Tmax) of MK-5172 in the plasma [ Time Frame: Predose to 24 hours post-dose on Day 7 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Multiple Dose Study of MK-5172 in Hepatitis C-Infected Participants (MK-5172-010 AM1)
Official Title ^ICMJE	A Multiple Dose Study to Evaluate Pharmacokinetics and Hepatitis C Virus RNA Dynamics Following Administration of MK-5172 in Hepatitis C Infected Patients
Brief Summary	This study will compare hepatic pharmacokinetics (PK) derived from liver tissue to plasma PK after administration of MK-5172 to participants with chronic hepatitis C virus (HCV) infection. Participants will be randomized to one of five different liver core needle biopsy schedules (at 4-, 8-, 12-, 24-, or 72-hours after the Day 7 dose).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hepatitis
Intervention ^ICMJE	Drug: MK-5172 MK-5172, orally, 100 mg tablets, one tablet per day for 7 days.
Study Arm (s)	Experimental: MK-5172 100 mg Participants will receive 100 mg MK-5172 each day for 7 days and will undergo liver core needle biopsy on Day 7. Intervention: Drug: MK-5172
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	16
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion criteria: Body Mass Index (BMI) ≥18.5 kg/m² and ≤36.0 kg/m² Chronic compensated, genotype 1 HCV infection No cirrhosis as confirmed by FibroSure®/Fibro Test® No need for anticoagulants, nonsteroidal anti-inflammatory agents, and aspirin for at least fourteen (14) days preceding the initial liver biopsy and continuing throughout the entire study Female participants of reproductive potential willing to use 2 medically acceptable forms of contraception for 2 weeks prior to start of treatment through 2 weeks after last study treatment Male participants with partners of reproductive potential willing to use 2 medically acceptable forms of contraception from first dose to 90 days after last dose Exclusion criteria: History of stroke, chronic seizures, or major neurological disorder Previous treatment with a Direct-Acting Antiviral (DAA) Evidence of high grade bridging fibrosis from prior liver biopsy within 3 years of study entry Evidence or history of chronic hepatitis not caused by HCV infection including but not limited to non-HCV viral hepatitis, nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, or autoimmune hepatitis Clinical or laboratory evidence of cirrhosis or other advanced liver disease Decompensated liver disease as indicated by a history of ascites, hepatic encephalopathy, or bleeding esophageal varices Diagnosed or suspected of having hepatocellular carcinoma Clinically significant abnormality on an electrocardiogram (ECG) Co-infection with human immunodeficiency virus (HIV) Positive Hepatitis B surface antigen or other evidence of active Hepatitis B infection History of gastric bypass surgery, bowel resection or other disorder that may interfere with absorption History of clinically significant uncontrolled endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases Clinically significant neoplastic disease Excessive use of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [354 mL], wine [118 mL], or distilled spirits [29.5 mL]) per day Current regular user (including use of any illicit drugs) or history of drug (including alcohol) abuse within the last 3 months Surgery, donation of 1 unit of blood (approximately 500 mL) or participation in another investigational study within a period of 4 weeks prior to the screening visit History of multiple and/or severe allergies, or anaphylactic reaction or intolerability to prescription or nonprescription drugs or food Pregnant or lactating Expecting to donate eggs or sperm
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01537900
Other Study ID Numbers ^ICMJE	5172-010
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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