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

Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184091
• Other study ID #: 1100.1259
• Status: Completed
• Phase: Phase 1
• First received: July 8, 2014
• Last updated: July 11, 2014
• Start date: January 1999

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. primary completion date: July 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

• matched with hepatic group regarding gender, age (+- 10 years), weight (+- 30 pounds) and smoking history

• Two baseline creatinine clearances (taken at least 3 days apart) > 80 ml/min

• No abnormalities on clinical or laboratory evaluations

• Female patients of childbearing potential must be willing to use a reliable form of contraception which must include a medically approved form of barrier contraception

• Patients who are able to provide written consent and comply with study requirements

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Renal Insufficiency

Intervention

Drug:
• Nevirapine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (Area under the plasma concentration time curve)		up to 7 days	No
Primary	Cmax (Maximum observed concentration of the analyte in plasma)		up to 7 days	No
Primary	Tmax (Time of maximum concentration of the analyte in plasma)		up to 7 days	No
Primary	T1/2 (Terminal half-life of the analyte in plasma)		up to 7 days	No
Primary	Vss/F (Volume of Distribution)		up to 7 days	No
Primary	MRT (Mean residence time of the analyte)		up to 7 days	No
Primary	CL/F (Apparent clearance of the analyte in plasma)		up to 7 days	No
Secondary	Number of patients with adverse events		up to 21 days	No
Secondary	Number of patients with abnormal changes in laboratory parameters		Screening, Day 0, Day 7	No

External Links

•   Link