Status:
COMPLETED
A Pharmacokinetics/Pharmacodynamics Study of SCH 900518 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C (Protocol No. P05104AM2)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
SCH 900518 is a potent oral inhibitor of HCV NS3 protease which disrupts hepatitis C virus (HCV) polyprotein processing. SCH 900518, when added to the current standard of care (SOC), peginterferon-alf...
Eligibility Criteria
Inclusion
- Adult subjects with CHC HCV genotype 1 with no previous treatment for CHC
- 18 to 55 years of age
- Weight between 40 and 125 kg
- Previously documented CHC genotype 1 infection
- Liver biopsy within 2 years of Screening with histology consistent with chronic hepatitis C and no evidence of bridging fibrosis or cirrhosis
- Subject and subject's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug
- Subjects must be willing to give written informed consent
Exclusion
- Prior treatment for hepatitis C other than herbal remedies
- HIV positive or known to be co-infected with hepatitis B
- Medically significant gallbladder or hepatobiliary findings on Screening ultrasound
- Use of any known significant inducers or substrates of CYP3A4 two weeks prior to start of study medications
- Use of herbal supplements (Milk Thistle permitted)
- Diabetic and hypertensive subjects with clinically significant ocular examination findings
- Current moderate or severe depression
- History of depression associated with any of the following:
- Hospitalization for depression
- Electroconvulsive therapy for depression.
- Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions
- Suicidal or homicidal ideation and/or attempt
- History of severe psychiatric disorders
- Past history or current use of lithium
- Clinical diagnosis of substance abuse of alcohol, intravenous drugs, inhalational (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs within 5 years of Day 1
- Past or current use of opiate agonist substitution therapy
- Any known pre-existing medical condition (CNS, cardiac, pulmonary, immune mediated) that could interfere with the subject's participation in and completion of the study
- Active clinical gout within the last year
- Hemoglobinopathy or coagulopathy
- Myelodysplastic syndromes
- Organ transplants other than cornea and hair
- Poor venous access that precludes routine peripheral blood sampling or an indwelling venous catheter
- Subjects with a history of gastric surgery (eg, stapling, banding, bypass) or subjects with a history of malabsorption disorders (eg, celiac sprue disease)
- Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated basal cell carcinoma of the skin). Subjects under evaluation for malignancy are not eligible.
- Subjects who are pregnant or nursing
- Subjects who intend to become pregnant during the study period
- Male subjects with partners who are, or intend to become, pregnant during the study period
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00797745
Start Date
November 1 2008
End Date
September 1 2010
Last Update
January 22 2015
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