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Safety, Pharmacokinetics, and Pharmacodynamics of MK-8876 in Participants With Hepatitis C Infection (MK-8876-003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01930058
Recruitment Status : Completed
First Posted : August 28, 2013
Results First Posted : February 4, 2016
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: MK-8876 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multiple Dose Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MK-8876 in Hepatitis C Patients
Actual Study Start Date : October 2, 2013
Actual Primary Completion Date : May 5, 2014
Actual Study Completion Date : May 5, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Panel A: HCV GT3 MK-8876 150 mg
Participants infected with HCV GT3 received 150 mg MK-8876 once daily (q.d.) by mouth for 7 days.
Drug: MK-8876
MK-8876 10 mg or 100 mg tablets taken q.d. by mouth.

Experimental: Panel B: HCV GT3 MK-8876 800 mg
Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
Drug: MK-8876
MK-8876 10 mg or 100 mg tablets taken q.d. by mouth.

Experimental: Panel E: HCV GT1a MK-8876 800 mg
Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
Drug: MK-8876
MK-8876 10 mg or 100 mg tablets taken q.d. by mouth.




Primary Outcome Measures :
  1. Mean Change From Baseline in HCV Viral Load [ Time Frame: Baseline and Day 7 ]
    The mean change (log10) in HCV ribonucleic acid (RNA) from baseline to Day 7 was determined for each panel of participants.


Secondary Outcome Measures :
  1. Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (hr) Post-dose (AUC0-24 hr) of MK-8876 [ Time Frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7 ]
    AUC0-24hr is a measure of the mean concentration of drug in plasma after dosing to 24 hr post-dose. Plasma AUC0-24hr was calculated on Day 1 and Day 7 of MK-8876 dosing.

  2. Maximum Plasma Concentration (Cmax) of MK-8876 [ Time Frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7 ]
    Cmax is a measure of the maximum plasma concentration of drug post-dose. Plasma Cmax was determined on Day 1 and Day 7 of MK-8876 dosing.

  3. Trough Plasma Concentration (C24hr) of MK-8876 [ Time Frame: 24 hours post-dose on Days 1 and 7 ]
    C24hr is a measure of the plasma drug concentration 24 hours post-dose (i.e., trough concentration). Plasma C24hr was determined on Day 1 and Day 7 of MK-8876 dosing.

  4. Time to Maximum Plasma Concentration (Tmax) of MK-8876 [ Time Frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7 ]
    Tmax is a measure of time required to reach the maximum plasma drug concentration post-dose. Plasma Tmax was calculated on Day 1 and Day 7 of MK-8876 dosing.

  5. Apparent Terminal Plasma Half-life (t½) of MK-8876 [ Time Frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Day 7 ]
    t½ is the time required for the maximum plasma drug concentration to reduce by 50% post-dose. Plasma t½ was determined on Day 7 of MK-8876 dosing.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930058


Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT01930058    
Other Study ID Numbers: 8876-003
2013-002566-39 ( EudraCT Number )
First Posted: August 28, 2013    Key Record Dates
Results First Posted: February 4, 2016
Last Update Posted: October 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections