Phase 1
Completed N=9
Safety, Pharmacokinetics, and Pharmacodynamics of MK-8876 in Participants With Hepatitis C Infection (MK-8876-003)
Source: ClinicalTrials.gov NCT01930058 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Mean Change From Baseline in HCV Viral Load — -0.42; -1.88; -3.39 Log10 change
Summary
This adaptive design study will evaluate the safety, pharmacokinetics, and effect on hepatitis C virus (HCV) RNA levels of multiple doses of MK-8876 in participants with HCV infection. The study will consist of 4 parts evaluating participants infected with specific hepatitis C virus genotypes and up to 10 panels allowing for additional participants to enroll in each panel as specified in the study analysis. The hypothesis evaluated in the study is that a ≥2.5 log IU/mL reduction in HCV RNA from Baseline will accompany multiple dose administration of MK-8876 in participants with HCV infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in HCV Viral Load |
-0.42; -1.88; -3.39 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (hr) Post-dose (AUC0-24 hr) of MK-8876 |
1.9; 4.83; 10.7; 5.23; 23.1; 23.1 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of MK-8876 |
177; 373; 773; 375; 1310; 1380 | — |
| SECONDARY Trough Plasma Concentration (C24hr) of MK-8876 |
59.1; 189; 370; 173; 907; 869 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of MK-8876 |
4; 6; 4; 4; 4; 4 | — |
| SECONDARY Apparent Terminal Plasma Half-life (t½) of MK-8876 |
77.1; 140; 62.5 | — |
Eligibility Criteria
Inclusion Criteria
- is male, or female of non-childbearing potential (non-childbearing potential is defined as postmenopausal without menses for ≥1 year or after medically documented hysterectomy, oophorectomy, or tubal ligation)
- agrees to use a medically acceptable method of contraception through 90 days after the last dose of study drug if participant has a female partner of childbearing potential must (males should use a condom and their partner of childbearing potential must use hormonal contraception, intrauterine device, diaphragm, cervical cap, or female condom)
- has a body mass index (BMI) between 18 and 37 kg/m^2
- has a clinical diagnosis of chronic HCV infection defined by positive serology for HCV for ≥6 months
- agrees to follow the smoking and other trial restrictions
Exclusion Criteria
- is mentally or legally institutionalized or incapacitated, has significant emotional problems at study start or has clinically significant psychiatric disorder of the last 5 years
- has a history of clinically significant endocrine, gastrointestinal (except HCV infection), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- has a history of stroke, chronic seizures, or major neurological disorder
- has a history of cancer (except adequately treated non-melanomatous skin carcinoma, carcinoma in situ of the cervix, or other malignancies which have been successfully treated for ≥10 years
- has a history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to drugs or food
- has a history of clinically significant hepatic disease, Gilbert's disease, biliary tract disease, or human immunodeficiency virus
- has had major surgery or donated or lost >1 unit of blood within 4 weeks before the study
- has participated in another investigational trial within 4 weeks before the study
- Is unable to refrain from or anticipates the use of any medication from 2 weeks before the study and throughout the study
- consumes >2 glasses of alcoholic beverages per day
- consumes >6 servings (1 serving is ~120 mg caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day
- is a regular user of any illicit drugs or history of drug abuse within 12 months of the study
- has evidence or history of chronic hepatitis not caused by HCV (except acute non-HCV-related hepatitis that resolved >6 months before the study)
- has previously received treatment with another HCV non-nucleoside inhibitor (previous use of other HCV investigational therapies or marketed compounds is permitted if treatment ended ≥3 months before the study)
- has clinical or laboratory evidence of advanced or decompensated liver disease
Data sourced from ClinicalTrials.gov (NCT01930058). 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.