HealthyPhase 1NCT02192463

Relative Bioavailability of Different Oral Viramune Extended Release Formulations Compared to Viramune® Oral Suspension in Healthy Male Volunteers

A Phase 1 study testing NVP ER 300 mg (KCR 20%) Medium Release, NVP ER 300 mg (KCR 25%) Medium Release and NVP ER 300 mg (KCR 30%) Slow Release in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study to determine the relative bioavailability of different oral Viramune Extended Release (ER) formulations compared to Viramune® Immediate Release (IR) tablet Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: NVP ER 300 mg (KCR 20%) Medium Release, NVP ER 300 mg (KCR 25%) Medium Release and NVP ER 300 mg (KCR 30%) Slow Release
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 204 participants
Where: No sites listed yet
Study dates: Apr 2006to Aug 2006
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 50 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 (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory
Age ≥18 and Age ≤50 years
Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice 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 22Show 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
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 corrected QT interval (QTc) >450 ms)
A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
History of disease which affects the present situation

About this study

Official title: Relative Bioavailability of Different Oral Viramune Extended Release Formulations Containing 300 mg or 400 mg Compared to 200 mg or 400 mg as One or Two 200 mg IR Tablets Following Administration in Healthy Male Volunteers - an Openlabel, Non-randomized, Parallel Group Study

Study to determine the relative bioavailability of different oral Viramune Extended Release (ER) formulations compared to Viramune® Immediate Release (IR) tablet

Conditions: Healthy
Being tested: NVP ER 300 mg (KCR 20%) Medium Release, NVP ER 300 mg (KCR 25%) Medium Release, NVP ER 300 mg (KCR 30%) Slow Release, NVP ER 400 mg (KCR 25%) Medium Release, NVP ER 300 mg (KCR 40%) Slow Release

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NVP ER 300 mg (KCR 20%) Medium ReleaseDrug
NVP ER 300 mg (KCR 25%) Medium ReleaseDrug
NVP ER 300 mg (KCR 30%) Slow ReleaseDrug
NVP ER 400 mg (KCR 25%) Medium ReleaseDrug
NVP ER 300 mg (KCR 40%) Slow ReleaseDrug
NVP ER 300 mg (ECR 20%) Fast ReleaseDrug
NVP ER 400 mg (KCR 20%) Medium ReleaseDrug
NVP ER 400 mg (KCR 30%) Slow ReleaseDrug
NVP ER 400 mg (KCR 40%) Slow ReleaseDrug
NVP ER 400 mg (ECR 20%) Fast ReleaseDrug
Nevirapine immediate release (IR) 200 mgDrug

Study groups in NCT02192463
Study group	Role	What they receive
Nevirapine (NVP) ER 300 mg (KCR 20%) Medium Release	Experimental	Not described Receives: Drug: NVP ER 300 mg (KCR 20%) Medium Release
NVP ER 300 mg (KCR 25%) Medium Release	Experimental	Not described Receives: Drug: NVP ER 300 mg (KCR 25%) Medium Release
NVP ER 300 mg (KCR 30%) Slow Release	Experimental	Not described Receives: Drug: NVP ER 300 mg (KCR 30%) Slow Release
NVP ER 400 mg (KCR 25%) Medium Release	Experimental	Not described Receives: Drug: NVP ER 400 mg (KCR 25%) Medium Release
NVP ER 300 mg (KCR 40%) Slow Release	Experimental	Not described Receives: Drug: NVP ER 300 mg (KCR 40%) Slow Release
NVP ER 300 mg (ECR 20%) Fast Release	Experimental	Not described Receives: Drug: NVP ER 300 mg (ECR 20%) Fast Release
NVP ER 400 mg (KCR 20%) Medium Release	Experimental	Not described Receives: Drug: NVP ER 400 mg (KCR 20%) Medium Release
NVP ER 400 mg (KCR 30%) Slow Release	Experimental	Not described Receives: Drug: NVP ER 400 mg (KCR 30%) Slow Release
NVP ER 400 mg (KCR 40%) Slow Release	Experimental	Not described Receives: Drug: NVP ER 400 mg (KCR 40%) Slow Release
NVP ER 400 mg (ECR 20%) Fast Release	Experimental	Not described Receives: Drug: NVP ER 400 mg (ECR 20%) Fast Release
Nevirapine IR 1 tablet	Active comparator	Not described Receives: Drug: Nevirapine immediate release (IR) 200 mg
Nevirapine IR 2 tablets	Active comparator	Not described Receives: Drug: Nevirapine immediate release (IR) 200 mg

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 post-dose
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 144 hours post-dose
C24 (measured concentration of the analyte in plasma at 24 hours post-dose)
Measured: 24 hours post-dose

Secondary outcomes (10)

Cmax/C24 ratio
Measured: up to 144 hours post-dose
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 post-dose
λz (terminal rate constant in plasma)
Measured: up to 144 hours post-dose
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 144 hours post-dose
MRTpo (mean residence time of the analyte in the body after po administration) CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: up to 144 hours post-dose
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 144 hours post-dose
ka (absorption rate constant)
Measured: up to 144 hours post-dose
Number of patients with adverse events
Measured: up to 36 days
Assessment of tolerability by investigator on a 4-point scale
Measured: within 8 days after last trial procedure
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 144 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Aug 2006

First posted16 Jul 2014 (estimated)
Study startApr 2006
Primary completionAug 2006

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: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02192463
Sponsor's protocol ID: 1100.1485
Status last verified: Jul 2014
First submitted: 15 Jul 2014
Last updated: 16 Jul 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of Different Oral Viramune Extended Release Formulations Containing 300 mg or 400 mg Compared to 200 mg or 400 mg as One or Two 200 mg IR Tablets Following Administration in Healthy Male Volunteers - an Openlabel, Non-randomized, Parallel Group Study
ClinicalTrials.gov ID: NCT02192463
Acronym / sponsor ID: 1100.1485
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Aug 2006 (actual)
First posted: 16 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 relative bioavailability of different oral Viramune Extended Release (ER) formulations compared to Viramune® Immediate Release (IR) tablet

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 12

Arm	Type	Receives
Nevirapine (NVP) ER 300 mg (KCR 20%) Medium Release	Experimental	Drug: NVP ER 300 mg (KCR 20%) Medium Release
NVP ER 300 mg (KCR 25%) Medium Release	Experimental	Drug: NVP ER 300 mg (KCR 25%) Medium Release
NVP ER 300 mg (KCR 30%) Slow Release	Experimental	Drug: NVP ER 300 mg (KCR 30%) Slow Release
NVP ER 400 mg (KCR 25%) Medium Release	Experimental	Drug: NVP ER 400 mg (KCR 25%) Medium Release
NVP ER 300 mg (KCR 40%) Slow Release	Experimental	Drug: NVP ER 300 mg (KCR 40%) Slow Release
NVP ER 300 mg (ECR 20%) Fast Release	Experimental	Drug: NVP ER 300 mg (ECR 20%) Fast Release
NVP ER 400 mg (KCR 20%) Medium Release	Experimental	Drug: NVP ER 400 mg (KCR 20%) Medium Release
NVP ER 400 mg (KCR 30%) Slow Release	Experimental	Drug: NVP ER 400 mg (KCR 30%) Slow Release
NVP ER 400 mg (KCR 40%) Slow Release	Experimental	Drug: NVP ER 400 mg (KCR 40%) Slow Release
NVP ER 400 mg (ECR 20%) Fast Release	Experimental	Drug: NVP ER 400 mg (ECR 20%) Fast Release
Nevirapine IR 1 tablet	Active comparator	Drug: Nevirapine immediate release (IR) 200 mg
Nevirapine IR 2 tablets	Active comparator	Drug: Nevirapine immediate release (IR) 200 mg

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy males according to the following criteria based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory
Age ≥18 and Age ≤50 years
Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Key exclusion criteria (22 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
NVP ER 300 mg (KCR 20%) Medium Release	Drug	Nevirapine (NVP) ER 300 mg (KCR 20%) Medium Release
NVP ER 300 mg (KCR 25%) Medium Release	Drug	NVP ER 300 mg (KCR 25%) Medium Release
NVP ER 300 mg (KCR 30%) Slow Release	Drug	NVP ER 300 mg (KCR 30%) Slow Release
NVP ER 400 mg (KCR 25%) Medium Release	Drug	NVP ER 400 mg (KCR 25%) Medium Release
NVP ER 300 mg (KCR 40%) Slow Release	Drug	NVP ER 300 mg (KCR 40%) Slow Release
NVP ER 300 mg (ECR 20%) Fast Release	Drug	NVP ER 300 mg (ECR 20%) Fast Release
NVP ER 400 mg (KCR 20%) Medium Release	Drug	NVP ER 400 mg (KCR 20%) Medium Release
NVP ER 400 mg (KCR 30%) Slow Release	Drug	NVP ER 400 mg (KCR 30%) Slow Release
NVP ER 400 mg (KCR 40%) Slow Release	Drug	NVP ER 400 mg (KCR 40%) Slow Release
NVP ER 400 mg (ECR 20%) Fast Release	Drug	NVP ER 400 mg (ECR 20%) Fast Release
Nevirapine immediate release (IR) 200 mg	Drug	Nevirapine IR 1 tablet, Nevirapine IR 2 tablets

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 post-dose
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 144 hours post-dose
C24 (measured concentration of the analyte in plasma at 24 hours post-dose)
Time frame: 24 hours post-dose

10 secondary outcomes

Cmax/C24 ratio
Time frame: up to 144 hours post-dose
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 post-dose
λz (terminal rate constant in plasma)
Time frame: up to 144 hours post-dose
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 144 hours post-dose
MRTpo (mean residence time of the analyte in the body after po administration) CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 144 hours post-dose
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 144 hours post-dose
ka (absorption rate constant)
Time frame: up to 144 hours post-dose
Number of patients with adverse events
Time frame: up to 36 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: within 8 days after last trial procedure
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 144 hours post-dose

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 16 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 NVP ER 300 mg (KCR 20%) Medium Release, NVP ER 300 mg (KCR 25%) Medium Release and NVP ER 300 mg (KCR 30%) Slow Release 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 4 inclusion and 22 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 16 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 post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02192463.

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 16 Jul 2014.