Renal InsufficiencyPhase 1NCT02184091
Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine
A Phase 1 study testing Nevirapine in people with Renal Insufficiency and Hepatic Insufficiency, run by Boehringer Ingelheim.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Insufficiency, Hepatic Insufficiency
- What is being tested?
- Nevirapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Jul 1999
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
About this study
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 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
- Conditions
- Renal Insufficiency, Hepatic Insufficiency
- Being tested
- Nevirapine
- Medical subject headings
- Renal Insufficiency, Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
| Study group | Role | What they receive |
|---|---|---|
| Nevirapine | Experimental | Single dose administration Receives: Drug: Nevirapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (Area under the plasma concentration time curve)
Measured: up to 7 days
Cmax (Maximum observed concentration of the analyte in plasma)
Measured: up to 7 days
Tmax (Time of maximum concentration of the analyte in plasma)
Measured: up to 7 days
T1/2 (Terminal half-life of the analyte in plasma)
Measured: up to 7 days
Vss/F (Volume of Distribution)
Measured: up to 7 days
MRT (Mean residence time of the analyte)
Measured: up to 7 days
CL/F (Apparent clearance of the analyte in plasma)
Measured: up to 7 days
Secondary outcomes (2)
Number of patients with adverse events
Measured: up to 21 days
Number of patients with abnormal changes in laboratory parameters
Measured: Screening, Day 0, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJan 1999
- Primary completionJul 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184091
- Sponsor's protocol ID
- 1100.1259
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Dose Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine (VIRAMUNE®)
- ClinicalTrials.gov ID
- NCT02184091
- Acronym / sponsor ID
- 1100.1259
- Conditions
- Renal Insufficiency, Hepatic Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 1999
- Primary completion
- Jul 1999 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nevirapine | Experimental | Drug: NevirapineSingle dose administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- For patients in the hepatic group
- For patients in the normal group, i.e. normal with respect to hepatic and renal function
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nevirapine | Drug | Nevirapine |
Primary outcome
AUC (Area under the plasma concentration time curve)
Time frame: up to 7 days
Cmax (Maximum observed concentration of the analyte in plasma)
Time frame: up to 7 days
Tmax (Time of maximum concentration of the analyte in plasma)
Time frame: up to 7 days
T1/2 (Terminal half-life of the analyte in plasma)
Time frame: up to 7 days
Vss/F (Volume of Distribution)
Time frame: up to 7 days
MRT (Mean residence time of the analyte)
Time frame: up to 7 days
CL/F (Apparent clearance of the analyte in plasma)
Time frame: up to 7 days
2 secondary outcomes
Number of patients with adverse events
Time frame: up to 21 days
Number of patients with abnormal changes in laboratory parameters
Time frame: Screening, Day 0, Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nevirapine in people with Renal Insufficiency and Hepatic Insufficiency, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (Area under the plasma concentration time curve) (time frame: up to 7 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.