Phase 1
Completed N=9
Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)
Source: ClinicalTrials.gov NCT02392494 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Percentage of Participants Experiencing an Adverse Event (AE) — 66.7; 66.7; 33.3 Percentage of Participants
Summary
The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to determine the ability of MK-1075 to reduce HCV viral load, following administration of a single dose in HCV-infected participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing an Adverse Event (AE) |
66.7; 66.7; 33.3 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Due to an AE |
0; 0; 0 | — |
| PRIMARY Maximum HCV Viral Load (VL) Change From Baseline Over Time Following Single-Dose MK-1075 |
5.72; 6.837; 6.31; 0.673; 1.15; 1.593 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female of non-child bearing potential
- In good health other than HCV genotype (GT) 1 infection
Exclusion Criteria
- Is mentally incapacitated or legally institutionalized
- Has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer
- Is positive for hepatitis B surface antigen (HBsAg) or human immunodeficiency virus (HIV)
- Has participated in another investigational trial within 4 weeks (or 5 half-lives) prior to Screening
- Consumes >2 alcoholic beverages a day or uses illegal drugs
- Has evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, or autoimmune hepatitis
- Has clinical or laboratory evidence of advanced or decompensated liver disease, evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior liver biopsy
Data sourced from ClinicalTrials.gov (NCT02392494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.