Chronic Hepatitis C
Conditions
Brief summary
This study will examine the effectiveness of 15 days of therapy with SCY-635 in reducing hepatitis C virus (HCV) RNA levels.
Interventions
DRUGPlacebo
Oral tablet given once or three times daily for 15 consecutive days
DRUGSCY-635
oral capsule
Sponsors
Scynexis, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
A potential subject will be eligible for participation in this study if he or she meets all of the following inclusion criteria: * The subject is either male or female, between the ages of 18 and 65 years (inclusive). * The subject has read and signed a Subject Informed Consent form to participate in the study. If the subject is not fluent in English, the Subject Informed Consent form must be translated into his or her native language. * Female subjects of childbearing potential (i.e., women not surgically sterile or at least two years postmenopausal) must agree to utilize one of the following forms of contraception from Screening through completion of the study: abstinence, barrier (condom, diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (six months minimum). Hormonal contraception (oral, transdermal, implant, or injection) is not permitted during the study period (i.e., from Screening through the Follow-up visit). Note: For women aged \<50 years, postmenopausal is defined as at least two years cessation of menses. For women aged ≥50 years, postmenopausal is defined as at least one year cessation of menses. Estrogen replacement is allowed during the study. * The subject exhibits quantifiable plasma levels of HCV-specific RNA in excess of 100,000 IU/mL as determined by the quantitative Roche COBAS taqMan assay. * The subject has a negative urine screen for amphetamines, barbiturates, cocaine, opiates, and phencyclidine at Screening. * If female, the subject has a negative serum pregnancy test at Screening (within 30 days prior to dosing) and a negative urine pregnancy test on Study Day -1.
Exclusion criteria
A potential subject will be excluded from participation in the study if he or she meets any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma HCV RNA level | 22 days |
| Incidence and severity of treatment-emergent adverse events and changes in laboratory values as measures of safety and tolerability. | 22 days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic assessment of SCY-635 | 22 days |
Countries
United States
Outcome results
None listed