HealthyPhase 1NCT02184312
Pharmacokinetic Properties of Two Dosages Nevirapine Extended Release (XR) Formulations Compared to VIRAMUNE® Tablet as Well as to Nevirapine XR Tablet in Healthy Male Volunteers
A Phase 1 study testing Nevirapine XR low dose, Nevirapine XR medium dose and Nevirapine XR high dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to determine the pharmacokinetic properties of 200 mg (2 x 100 mg tablets once daily) and 300 mg (3 x 100 mg tablets once daily) Nevirapine extended release formulations and to estimate relative bioavailability of these formulations as compared to 200 mg VIRAMUNE® tablet as well as to 400 mg Nevirapine extended… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nevirapine XR low dose, Nevirapine XR medium dose and Nevirapine XR high dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jul 2008
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory; values within normal ranges or deviating from normal without clinical relevance as considered by the investigator
- Values of Liver Function Test (LFT) have to be within normal ranges
- Age ≥18 and Age ≤60 years
- Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- Subjects must agree to minimize the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the post study medical examination. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month)
- Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation
Who cannot join
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders of clinical relevance
- Surgery of the gastrointestinal tract (except appendectomy and herniotomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
Show all 27Show fewer
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Participation to trial BI 1100.1485 or any other intake of Nevirapine
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- History of disease which affects the present situation
- Inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study
- Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study
- Vulnerable subjects (e.g. persons kept in detention)
About this study
Official title: An Open-label, Non-randomised, Single-dose, Parallel-group Study of Pharmacokinetic Properties of 200 mg (2 x 100 mg Tablets Once Daily) and 300 mg (3 x 100 mg Tablets Once Daily) Nevirapine Extended Release Formulations Compared to 200 mg VIRAMUNE® Tablet as Well as to 400 mg Nevirapine Extended Release Tablet Following Oral Administration in Healthy Male Volunteers
Study to determine the pharmacokinetic properties of 200 mg (2 x 100 mg tablets once daily) and 300 mg (3 x 100 mg tablets once daily) Nevirapine extended release formulations and to estimate relative bioavailability of these formulations as compared to 200 mg VIRAMUNE® tablet as well as to 400 mg Nevirapine extended release tablet
- Conditions
- Healthy
- Being tested
- Nevirapine XR low dose, Nevirapine XR medium dose, Nevirapine XR high dose, Nevirapine (VIRAMUNE®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nevirapine XR low doseDrug
Nevirapine XR medium doseDrug
Nevirapine XR high doseDrug
Nevirapine (VIRAMUNE®)Drug
| Study group | Role | What they receive |
|---|---|---|
| Nevirapine XR low dose | Experimental | Not described Receives: Drug: Nevirapine XR low dose |
| Nevirapine XR medium dose | Experimental | Not described Receives: Drug: Nevirapine XR medium dose |
| Nevirapine XR high dose | Active comparator | Not described Receives: Drug: Nevirapine XR high dose |
| Nevirapine (VIRAMUNE®) | Active comparator | commercial product Receives: Drug: Nevirapine (VIRAMUNE®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 144 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 144 hours after drug administration
Secondary outcomes (13)
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 144 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 144 hours after drug administration
λz (terminal rate constant in plasma)
Measured: up to 144 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 144 hours after drug administration
MRTpo (mean residence time of the analyte in the body after po administration)
Measured: up to 144 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: up to 144 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 144 hours after drug administration
ka (absorption rate constant)
Measured: up to 144 hours after drug administration
Number of patients with adverse events
Measured: up to 36 days
Number of patients with abnormal changes in laboratory parameters
Measured: Screening, Day 1, 2, 3, 4, 5, 7, 15
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR))
Measured: Screening, Day 1, 2, 15
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Measured: Screening, Day 1, 15
Assessment of tolerability by investigator on a 4-point scale
Measured: up to 15 days after drug administration
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 startApr 2008
- Primary completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 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
- NCT02184312
- Sponsor's protocol ID
- 1100.1517
- 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, Non-randomised, Single-dose, Parallel-group Study of Pharmacokinetic Properties of 200 mg (2 x 100 mg Tablets Once Daily) and 300 mg (3 x 100 mg Tablets Once Daily) Nevirapine Extended Release Formulations Compared to 200 mg VIRAMUNE® Tablet as Well as to 400 mg Nevirapine Extended Release Tablet Following Oral Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02184312
- Acronym / sponsor ID
- 1100.1517
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jul 2008 (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 determine the pharmacokinetic properties of 200 mg (2 x 100 mg tablets once daily) and 300 mg (3 x 100 mg tablets once daily) Nevirapine extended release formulations and to estimate relative bioavailability of these formulations as compared to 200 mg VIRAMUNE® tablet as well as to 400 mg Nevirapine extended release tablet
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nevirapine XR low dose | Experimental | Drug: Nevirapine XR low dose |
| Nevirapine XR medium dose | Experimental | Drug: Nevirapine XR medium dose |
| Nevirapine XR high dose | Active comparator | Drug: Nevirapine XR high dose |
| Nevirapine (VIRAMUNE®) | Active comparator | Drug: Nevirapine (VIRAMUNE®)commercial product |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory; values within normal ranges or deviating from normal without clinical relevance as considered by the investigator
- Values of Liver Function Test (LFT) have to be within normal ranges
- Age ≥18 and Age ≤60 years
- Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- Subjects must agree to minimize the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the post study medical examination. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month)
Key exclusion criteria (27 listed)
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders of clinical relevance
- Surgery of the gastrointestinal tract (except appendectomy and herniotomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
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 XR low dose | Drug | Nevirapine XR low dose |
| Nevirapine XR medium dose | Drug | Nevirapine XR medium dose |
| Nevirapine XR high dose | Drug | Nevirapine XR high dose |
| Nevirapine (VIRAMUNE®) | Drug | Nevirapine (VIRAMUNE®) |
Primary outcome
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 144 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 144 hours after drug administration
13 secondary outcomes
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 144 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 144 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 144 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 144 hours after drug administration
MRTpo (mean residence time of the analyte in the body after po administration)
Time frame: up to 144 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 144 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 144 hours after drug administration
ka (absorption rate constant)
Time frame: up to 144 hours after drug administration
Number of patients with adverse events
Time frame: up to 36 days
Number of patients with abnormal changes in laboratory parameters
Time frame: Screening, Day 1, 2, 3, 4, 5, 7, 15
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR))
Time frame: Screening, Day 1, 2, 15
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Time frame: Screening, Day 1, 15
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 15 days after drug administration
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.
- Related InfoLink provided by the sponsor.
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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 XR low dose, Nevirapine XR medium dose and Nevirapine XR high dose in people with Healthy, 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 7 inclusion and 27 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?
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) (time frame: up to 144 hours after drug administration). The study lists 2 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.