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

Primary Purpose

Renal Insufficiency, Hepatic Insufficiency

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Nevirapine

About this trial

This is an interventional treatment trial for Renal Insufficiency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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
- 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nevirapine

Arm Description

Single dose administration

Outcomes

Primary Outcome Measures

AUC (Area under the plasma concentration time curve)

Cmax (Maximum observed concentration of the analyte in plasma)

Tmax (Time of maximum concentration of the analyte in plasma)

T1/2 (Terminal half-life of the analyte in plasma)

Vss/F (Volume of Distribution)

MRT (Mean residence time of the analyte)

CL/F (Apparent clearance of the analyte in plasma)

Secondary Outcome Measures

Number of patients with adverse events

Number of patients with abnormal changes in laboratory parameters

Full Information

NCT ID

NCT02184091

First Posted

July 8, 2014

Last Updated

July 11, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02184091

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

January 1999 (undefined)

Primary Completion Date

July 1999 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Insufficiency, Hepatic Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nevirapine

Arm Type

Experimental

Arm Description

Single dose administration

Intervention Type

Drug

Intervention Name(s)

Nevirapine

Primary Outcome Measure Information:

Title

AUC (Area under the plasma concentration time curve)

Time Frame

up to 7 days

Title

Cmax (Maximum observed concentration of the analyte in plasma)

Time Frame

up to 7 days

Title

Tmax (Time of maximum concentration of the analyte in plasma)

Time Frame

up to 7 days

Title

T1/2 (Terminal half-life of the analyte in plasma)

Time Frame

up to 7 days

Title

Vss/F (Volume of Distribution)

Time Frame

up to 7 days

Title

MRT (Mean residence time of the analyte)

Time Frame

up to 7 days

Title

CL/F (Apparent clearance of the analyte in plasma)

Time Frame

up to 7 days

Secondary Outcome Measure Information:

Title

Number of patients with adverse events

Time Frame

up to 21 days

Title

Number of patients with abnormal changes in laboratory parameters

Time Frame

Screening, Day 0, Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1259_U00-3125.pdf

Description

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

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