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A Study Evaluating the Pharmacokinetics of Doravirine (MK-1439) in Participants With Severe Renal Impairment (MK-1439-051)

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: NCT02641067
Recruitment Status : Completed
First Posted : December 29, 2015
Results First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will evaluate the effect of severe renal impairment on the pharmacokinetics of doravirine.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: Doravirine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-1439 (Doravirine) in Subjects With Severe Renal Impairment
Actual Study Start Date : January 26, 2016
Actual Primary Completion Date : May 14, 2016
Actual Study Completion Date : May 25, 2016

Arm Intervention/treatment
Experimental: Severe Renal Impairment
Participants with severe renal impairment receive a single oral dose of 100 mg doravirine
Drug: Doravirine
Following an overnight fast, a single coated tablet of 100 mg doravirine will be administered orally
Other Name: MK-1439, PIFELTRO

Experimental: Healthy Matched Control
Healthy participants matched for age and weight receive a single oral dose of 100 mg doravirine
Drug: Doravirine
Following an overnight fast, a single coated tablet of 100 mg doravirine will be administered orally
Other Name: MK-1439, PIFELTRO




Primary Outcome Measures :
  1. Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞) of Doravirine [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment ]
    Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.

  2. Plasma Concentration of Doravirine at 24 Hours Postdose (C24) [ Time Frame: 24 hours postdose ]
    Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.

  3. Maximum Observed Plasma Concentration (Cmax) of Doravirine [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment ]
    Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.

  4. Area Under the Plasma Concentration Versus Time Curve From 0 Hours to the Time of Last Quantifiable Sample of Doravirine (AUC 0-last) [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment ]
    Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.

  5. Time to Maximum Observed Plasma Concentration (Tmax) of Doravirine [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment ]
    Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.

  6. Apparent Terminal Half-life (t1/2) of Plasma Doravirine [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment ]
    Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.

  7. Apparent Clearance of Plasma Doravirine After Extravascular Administration (CL/F) [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment ]
    Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.

  8. Apparent Volume of Distribution of Plasma Doravirine During the Terminal Phase (Vz/F) [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment ]
    Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • is a non-smoker or moderate smoker
  • has a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m^2
  • other than renal impairment, participant is judged to be in good health based on medical history, physical examination, vital signs, and laboratory safety tests
  • female informed of the risks of pregnancy, agree not to become pregnant while participating in this study. Female of childbearing potential must either be sexually inactive for 14 days prior to dosing and throughout the study, or uses one acceptable birth control method
  • female of non-childbearing potential must have undergone sterilization procedures at least 6 months prior to dosing.
  • Participants with severe renal impairment only: has baseline estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2

Exclusion Criteria:

  • is mentally or legally incapacitated or has significant emotional problems
  • has a history or presence of clinically significant medical or psychiatric condition or disease
  • has history or presence of alcoholism or drug abuse within the past 2 years
  • has history or presence of hypersensitivity or idiosyncratic reaction to the study drug, any inactive ingredients, or related compounds
  • has history or presence of renal artery stenosis
  • has had a renal transplant or nephrectomy
  • has rapidly fluctuating renal function as determined by historical measurements
  • female is pregnant or lactating
  • has positive results for the urine or saliva drug and urine or breath alcohol screen at screening or check-in
  • has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
  • is unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study. Certain medications including those to treat kidney disease will be permitted. Other medications may be permitted following consultation with the Sponsor Clinical Monitor.
  • is unable to refrain from or anticipates the use of inducers of cytochrome P450 3A (CYP3A) or permeability glycoprotein (P-gp) transporters for at least 28 days prior to dosing and throughout the study.
  • has been on a diet incompatible with the on-study diet, within 28 days prior to dosing, and throughout the study
  • has donated blood or had significant blood loss within 56 days prior to dosing
  • has donated plasma within 7 days prior to dosing
  • has participated in another clinical trial within 28 days prior to dosing

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): NCT02641067


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02641067    
Other Study ID Numbers: 1439-051
MK-1439-051 ( Other Identifier: Merck Protocol Number )
First Posted: December 29, 2015    Key Record Dates
Results First Posted: February 8, 2019
Last Update Posted: February 8, 2019
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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Renal Insufficiency
Kidney Diseases
Urologic Diseases