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 April 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01537900
First received: February 17, 2012
Last updated: April 8, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis |
Drug: MK-5172 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multiple Dose Study to Evaluate Pharmacokinetics and Hepatitis C Virus RNA Dynamics Following Administration of MK-5172 in Hepatitis C Infected Patients |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 16 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: MK-5172
MK-5172, orally, 100 mg tablets, one tablet per day for 7 days.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01537900 History of Changes |
| Other Study ID Numbers: | 5172-010 |
| Study First Received: | February 17, 2012 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C 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 May 16, 2013