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

NCT ID: NCT02641067

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-26
• Study Completion Date: 2016-05-25

Brief Summary

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

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Severe Renal Impairment

Participants with severe renal impairment receive a single oral dose of 100 mg doravirine

Group Type: EXPERIMENTAL

Doravirine

Intervention Type: DRUG

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

Healthy Matched Control

Healthy participants matched for age and weight receive a single oral dose of 100 mg doravirine

Group Type: EXPERIMENTAL

Doravirine

Intervention Type: DRUG

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

Interventions

Doravirine

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

Intervention Type: DRUG

Other Intervention Names

MK-1439, PIFELTRO

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Ankrom W, Yee KL, Sanchez RI, Adedoyin A, Fan L, Marbury T, Preston RA, Iwamoto M, Khalilieh SG. Severe Renal Impairment Has Minimal Impact on Doravirine Pharmacokinetics. Antimicrob Agents Chemother. 2018 Jul 27;62(8):e00326-18. doi: 10.1128/AAC.00326-18. Print 2018 Aug.

Reference Type: DERIVED

PMID: 29891610 (View on PubMed)

Other Identifiers

MK-1439-051

Identifier Type: OTHER

Identifier Source: secondary_id

1439-051

Identifier Type: -

Identifier Source: org_study_id