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Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine | Clinical Trials | Clareo Health

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Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine

An Open-Label, Single Dose Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine (VIRAMUNE®)

NCT02184091•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

Study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to establish an appropriate dose and/or dosing frequency for renally- and hepatically-impaired patients

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients of any race between the ages of 18 and 75 years with weight within 30% of normal for gender, height and frame as specified by the Metropolitan Life Insurance Table
•For patients in the renal group: stable creatinine clearance based on two estimations taken at least 3 days apart, corresponding to one of four groups:
•* Group 1 (mild dysfunction) = 50 ml/min \<= Creatinine Clearance (CLcr) \< 80 ml/min
•* Group 2 (moderate dysfunction) = 30 ml/min \<= CLcr \< 50 ml/min
•* Group 3 (severe dysfunction) = CLcr \< 30 ml/min and
•* Group 4 = end-stage renal disease (ESRD) requiring dialysis
•For patients in the hepatic group
•* Two baseline creatinine clearances (taken at least 3 days apart) \> 80 ml/min
•* clinically diagnosed with hepatic insufficiency and Class A or B liver disease according to Child-Pugh's Classification; subjects must have a Child-Pugh score of 5-9 points
•For patients in the normal group, i.e. normal with respect to hepatic and renal function
+5 more criteria

Exclusion Criteria

•Female patients who are pregnant or breast-feeding
•Seated systolic blood pressure either \< 100 mmHg or \> 150 mmHg and/or heart rate either \< 50 beats/min or \> 90 beats/min
•History of any illness or drug allergy that in the opinion of the investigator might confound the results of the study or pose additional risk in administering nevirapine to the subject
•Patients who have had an acute illness or hospitalization other than for routine dialysis within 2 weeks prior to study initiation
•Patients who are currently taking any over-the-counter drug within 3 days prior to study initiation, or who are currently taking any prescription drug that in the opinion of the investigator in consultation with Boehringer Ingelheim Pharmaceuticals Incorporated (BIPI) medical monitor and pharmacokineticist might interfere with the absorption, distribution or metabolism on the test drug
•Significant electrocardiogram (ECG) abnormalities

Key Dates

Start Date

January 1, 1999

Primary Completion Date

July 1, 1999

Last Updated

July 14, 2014

Enrollment

ACTUAL participants

Conditions

Renal InsufficiencyHepatic Insufficiency

Interventions

Nevirapine

DRUG

Product Surveillance Registry

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RECRUITING

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

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Hepatic InsufficiencyCirrhosis, Liver

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine

Inclusion Criteria

Exclusion Criteria

Product Surveillance Registry

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