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Phase 1 Completed N=9 Randomized Treatment

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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