Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Merck Sharp & Dohme Corp.


Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier
NCT02641067

First received: December 23, 2015
Last updated: November 20, 2017
Last Verified: November 2017
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
Renal Impairment

Drug : Doravirine
Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures

  • Area under the concentration versus time curve (AUC) of doravirine from 0 to infinity (AUC 0-∞) [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose; and 96 hours post-dose for severe renal impairment only ]
  • Plasma drug concentration of doravirine at 24 hours postdose (C24) [ Time Frame: 24 hours post-dose ]
  • 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; and 96 hours post-dose for severe renal impairment only ]

Enrollment: 16
Study Start Date: January 26, 2016
Study Completion Date: May 25, 2016
Primary Completion Date: May 14, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Experimental: Healthy Matched Controls
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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 75 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:
Participants with renal impairment:

  • 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.
  • has baseline estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2


Exclusion Criteria:

    Participants with renal impairment:
  • 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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02641067

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information

More Information


Responsible Party: Merck Sharp & Dohme Corp.  
ClinicalTrials.gov Identifier: NCT02641067   History of Changes  
Other Study ID Numbers: 1439-051  
Study First Received: December 23, 2015  
Last Updated: November 20, 2017  

Additional relevant MeSH terms:
Renal Insufficiency

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.