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Trial record 28 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR
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The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)

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ClinicalTrials.gov Identifier: NCT01937975
Recruitment Status : Completed
First Posted : September 10, 2013
Results First Posted : March 4, 2016
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal impairment. Both groups were compared to healthy matched controls.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Renal Impairment Drug: Grazoprevir Drug: Elbasvir Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Investigate the Pharmacokinetics of MK-5172 and MK-8742 in Subjects With Renal Insufficiency
Actual Study Start Date : September 6, 2013
Actual Primary Completion Date : December 17, 2013
Actual Study Completion Date : December 17, 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Participants with End Stage Renal Disease on Hemodialysis
Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days..
 Drug: Grazoprevir
100 mg oral tablet administered once a day for 10 days

Drug: Elbasvir
50 mg oral tablet administered once a day for 10 days
Experimental: Participants with Severe Renal Impairment
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
 Drug: Grazoprevir
100 mg oral tablet administered once a day for 10 days

Drug: Elbasvir
50 mg oral tablet administered once a day for 10 days
Experimental: Healthy Participants
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
 Drug: Grazoprevir
100 mg oral tablet administered once a day for 10 days

Drug: Elbasvir
50 mg oral tablet administered once a day for 10 days


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Grazoprevir [ Time Frame: Up to 24 hours postdose ]
    Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)

  2. Plasma Concentration at 24 Hours Postdose (C24hr) of Grazoprevir [ Time Frame: 24 hours postdose ]
    Blood for determination of Grazoprevir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)

  3. Maximum Plasma Concentration (Cmax) of Grazoprevir [ Time Frame: Up to 120 hours postdose ]
    Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9

  4. Time of Maximum Plasma Concentration (Tmax) of Grazoprevir [ Time Frame: Up to 120 hours postdose ]
    Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9

  5. Apparent Terminal Half-life (T1/2) of Grazoprevir [ Time Frame: Up to 120 hours postdose ]
    Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10

  6. Apparent Clearance After Extravascular Administration (CL/F) of Grazoprevir [ Time Frame: Up to 24 hours postdose ]
    Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)

  7. Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Grazoprevir [ Time Frame: Up to 24 hours postdose ]
    Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10

  8. Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Elbasvir [ Time Frame: Up to 24 hours postdose ]
    Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)

  9. Plasma Concentration at 24 Hours Postdose (C24hr) of Elbasvir [ Time Frame: 24 hours postdose ]
    Blood for determination of Elbasvir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)

  10. Maximum Plasma Concentration (Cmax) of Elbasvir [ Time Frame: Up to 120 hours postdose ]
    Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9

  11. Time of Maximum Plasma Concentration (Tmax) of Elbasvir [ Time Frame: Up to 120 hours postdose ]
    Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9

  12. Apparent Terminal Half-life (T1/2) of Elbasvir [ Time Frame: Up to 120 hours postdose ]
    Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10

  13. Apparent Clearance After Extravascular Administration (CL/F) of Elbasvir [ Time Frame: Up to 24 hours postdose ]
    Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)

  14. Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Elbasvir [ Time Frame: Up to 24 hours postdose ]
    Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All Participants

  • For a female of childbearing potential: either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using an acceptable birth control method. Females of non-childbearing potential must have undergone a sterilization procedure at least 6 months prior to the first dose
  • Non-vasectomized male participants must agree to use a condom with spermicide or abstain from sexual intercourse during the trial and for 90 days after stopping the study medication and agree not to donate sperm during this time period Participants with ESRD on HD
  • Maintained on a stable regimen of HD within 3 months prior to first dosing Participants with Severe Renal Impairment
  • Estimated glomerular filtration rate (eGFR) at screening is < 30 mL/min/1.73m^2 Healthy Controls
  • Participant is within ± 10 years of the mean age and within 10% of the mean body mass index of severe renal impairment participants
  • eGFR at screening is >=80 mL/min/1.73m^2

Exclusion Criteria:

All Participants

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease whose current condition is considered unstable
  • History or presence of alcoholism and drug abuse within the past 6 months
  • Female participants who are pregnant or lactating
  • Regular user of any medication (including over the counter) that would significantly alter GFR
  • Donation of blood or significant blood loss within 56 days prior to the first dose of study medication(s)
  • Plasma donation within 7 days prior to the first dose of study medication(s)
  • A renal transplant or nephrectomy Participants with ESRD or Severe Renal Impairment
  • Rapidly fluctuating renal function
Contacts and Locations
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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): NCT01937975


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information
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Publications of Results:

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01937975     History of Changes
Other Study ID Numbers: 5172-050
First Posted: September 10, 2013    Key Record Dates
Results First Posted: March 4, 2016
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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MK-5172
Hepatitis C
Hepatitis C, Chronic
Renal Insufficiency
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Kidney Diseases
Urologic Diseases
Antiviral Agents
Anti-Infective Agents