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Completed

NCT Number: NCT01937975

The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Kidney Diseases Liver Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Renal Impairment Renal Insufficiency Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grazoprevir

Drug

100 mg oral tablet administered once a day for 10 days

Elbasvir

Drug

50 mg oral tablet administered once a day for 10 days

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label Study to Investigate the Pharmacokinetics of MK-5172 and MK-8742 in Subjects With Renal Insufficiency

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 10, 2013
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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