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Completed

NCT Number: NCT02641067

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

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

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 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

  • 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

Treatment and study plan

Doravirine

Drug

Following an overnight fast, a single coated tablet of 100 mg doravirine will be administered orally

Other names: MK-1439, PIFELTRO

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-1439 (Doravirine) in Subjects With Severe Renal Impairment

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 29, 2015
Registry last updated
Feb 8, 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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