Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8742 in Hepatitis C Infected Males
Brief Summary: The purpose of this study is to assess the safety, pharmacokinetics (PK) and pharmacodynamics of elbasvir (MK-8742) in Hepatitis C Virus (HCV)-infected participants. There will be 3 parts to this study; Part I will enroll only genotype (GT) 1 HCV-infected participants, Part II will enroll GT3 HCV-infected participants, and Part III will enroll only GT1a HCV-infected participants. All parts may run concurrently, or Parts II and III may be staggered.

Hypothesis (Part I): At a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, elbasvir administered for 5 consecutive days has superior antiviral activity in GT1 HCV-infected participants compared to placebo, as measured by change from baseline in plasma HCV ribonucleic acid (RNA; log 10 copies/mL) at Day 5, 24-hour postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).

Hypothesis (Part II): At a dose that is sufficiently safe in GT3 HCV-infected participants, the mean maximum reduction in HCV viral load is greater following multiple dose oral administration of elbasvir as compared to placebo.

Hypothesis (Part III): At a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, elbasvir administered for 5 consecutive days has superior antiviral activity in GT1a HCV-infected participants compared to placebo, as measured by change from baseline in plasma HCV RNA (log 10 copies/mL) at Day 5, 24-hour postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).


Options:
A: Inclusion Criteria:

* Body Mass Index (BMI) of 18 to ≤ 37 kg/m\^2
* Clinical diagnosis of chronic HCV infection defined by positive serology for HCV for at least 6 months and detectable HCV RNA in peripheral blood ≥105 IU/mL at screening
* Participant must be infected with HCV GT1a, GT1b, or GT 3

Exclusion Criteria:

* Co-infection with GT1 and GT3
* Estimated creatinine clearance of ≤70 mL/min based on the Cockcroft-Gault equation
* History of stroke, chronic seizures, or major neurological disorder
* History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* History of neoplastic disease
* Positive Hepatitis B surface antigen at the pre-study (screening) visit
* Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit.
* Previous treatments (s) with nonstructural protein 5A (NS5A) inhibitors
* \<4 weeks since administration of any experimental protease inhibitor
* Previous exposure to interferon-alpha and/or ribavirin within 3 month prior to the first dose of elbasvir in the study
* Clinical or laboratory evidence of advanced or decompensated liver disease
B: Key Inclusion Criteria:

* Patients chronically infected with hepatitis C virus (HCV) genotype 1
* HCV RNA viral load of ≥10\*5\* IU/mL (100,000 IU/mL) at screening
* Treatment naive

Key Exclusion Criteria:

* Women of child-bearing potential
* Cirrhosis
* Coinfection with HIV or hepatitis B virus
C: Inclusion Criteria:

* Age between 18 and 60 years;
* Body weight between 45 and 125 kg;
* Documented chronic hepatitis C genotype 1;
* Liver biopsy with histology consistent with chronic hepatitis and no other etiology for chronic liver disease within of 5 years of Day 1;
* Participant and participant's partner(s) must each agree to use acceptable methods of contraception 2 weeks prior to Day 1 and at least 6 months after the last dose of study medication;
* Written informed consent.

Exclusion Criteria:

Include, but are not limited to, the following:

* Prior treatment for hepatitis C;
* Co-infection with HIV or hepatitis B virus (HBsAg positive);
* Evidence of decompensated liver disease;
* Diabetic and hypertensive participants with clinically significant ocular exam findings;
* Pre-existing psychiatric condition, including but not limited to:

  * 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 (including but not limited to schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder or mania);
  * Past history or current use of lithium;
  * Past history or current use of antipsychotic drugs for listed conditions.
* Substance abuse within protocol specified timeframes;
* Pre-existing medical conditions that could interfere with the participant's participation in and completion of the study, including but not limited to chronic pulmonary disease, cardiac dysfunction or immunologically-mediated disease;
* Active or suspected malignancy or history of malignancy within the past 5 years;
* Participants who are pregnant or nursing; participants who intend to become pregnant during the study period. Male participants with partners who are, or intend to become, pregnant during the study period.
* Treatment with any investigational drug or participation in any clinical trial 30 days within Screening;
* Hemoglobin \<12 g/dL for females and \<13 g/dL for males;
* Neutrophils \<1500 mm\^3; Blacks: \<1200/mm\^3;
* Platelets \<100,000/mm\^3;
* Other clinically significant laboratory test abnormalities.
D: Inclusion Criteria:

* Body weight ≥ 40 kg
* HCV RNA ≥ 10\^5 IU/mL at screening

Exclusion Criteria:

* Current or prior history of any clinically-significant illness (other than HCV)
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of a non-HCV etiology
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Answer: A