HealthyPhase 1NCT02183441
Bioavailability of BI 1356 After Co-administration With Ritonavir Compared to the Bioavailability of BI 1356 Alone in Healthy Male Volunteers
A Phase 1 study testing BI 1356 and Ritonavir in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate the effect of the P-gp and cytochrome P450 (CYP) 3A4 inhibitor ritonavir on the pharmacokinetics of BI 1356 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?
- BI 1356 and Ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jun 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 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 tests
- Age ≥ 18 and Age ≤ 50 years
- BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
- 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
- Surgery of the gastrointestinal tract (except appendectomy)
- 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 24Show fewer
- Chronic or relevant acute infections (e.g. HIV)
- 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 five 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 (especially unspecific inducing agents like St.John´s wort (Hypericum perforatum) or drugs which prolong the QT/QTc interval 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) or inability to stop alcoholic beverages for 24 hours prior to dosing and up to the last sampling time point
- 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 de points (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Galactose intolerance
- Lactase deficiency
- Glucose-galactose-malabsorption
About this study
Official title: Relative Bioavailability of a Single Oral Dose of BI 1356 (5 mg) After Co-administration With Multiple Oral Doses of Ritonavir (200 mg Bid for 3 Days) Compared to the Bioavailability of a Single Oral Dose of BI 1356 (5 mg) Alone in Healthy Male Volunteers (an Open-label, Randomized, Two-way Crossover, Clinical Phase I Study)
Study to investigate the effect of the P-gp and cytochrome P450 (CYP) 3A4 inhibitor ritonavir on the pharmacokinetics of BI 1356
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1356Drug
RitonavirDrug
Also called Norvir®
| Study group | Role | What they receive |
|---|---|---|
| BI 1356 plus ritonavir | Experimental | Treatment A: 3 days of ritonavir, 1 day BI 1356 Receives: Drug: BI 1356; Drug: Ritonavir |
| BI 1356 | Active comparator | Treatment B: BI 1356 alone Receives: Drug: BI 1356 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24 (Area under the concentration-time curve of BI 1356 in plasma over the time interval from 0 to 24 hours)
Measured: up to 24 hours after start of treatment
Cmax (Maximum measured concentration of BI 1356 in plasma)
Measured: up to 96 hours after start of treatment
Secondary outcomes (13)
AUC (Area under the concentration time curve of the analytes in plasma at different time points)
Measured: up to 96 hours after start of treatment
%AUCtz-∞ (Percentage of the extrapolated part of the area under the concentration time curve of the analytes in plasma from 0 to infinity)
Measured: up to 96 hours after start of treatment
tmax (Time from dosing to the maximum concentration of the analytes in plasma)
Measured: up to 96 hours after start of treatment
t1/2 (Terminal half-life of the analytes in plasma)
Measured: up to 96 hours after start of treatment
λz (Terminal rate constant of the analytes in plasma)
Measured: up to 96 hours after start of treatment
MRTpo (Mean residence time in the body after po administration of the analytes in plasma)
Measured: up to 96 hours after start of treatment
CL/F (Apparent clearance of BI 1356 in plasma after extravascular administration )
Measured: up to 96 hours after start of treatment
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) of BI 1356
Measured: up to 96 hours after start of treatment
Aet1-t2 (Amount of the analytes that is eliminated in urine from the time interval t1 to t2)
Measured: up to 24 hours after start of treatment
fet1-t2 (Fraction of BI 1356 excreted unchanged in urine from time point t1 to t2)
Measured: up to 24 hours after start of treatment
CLR,t1-t2 (Renal clearance of the analytes in plasma)
Measured: up to 24 hours after start of treatment
Cmax (Maximum measured concentration of CD 1750 in Plasma)
Measured: up to 96 hours after start of treatment
Number of patients with adverse events
Measured: up to 53 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startApr 2008
- Primary completionJun 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02183441
- Sponsor's protocol ID
- 1218.31
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of a Single Oral Dose of BI 1356 (5 mg) After Co-administration With Multiple Oral Doses of Ritonavir (200 mg Bid for 3 Days) Compared to the Bioavailability of a Single Oral Dose of BI 1356 (5 mg) Alone in Healthy Male Volunteers (an Open-label, Randomized, Two-way Crossover, Clinical Phase I Study)
- ClinicalTrials.gov ID
- NCT02183441
- Acronym / sponsor ID
- 1218.31
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (actual)
- First posted
- 8 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 investigate the effect of the P-gp and cytochrome P450 (CYP) 3A4 inhibitor ritonavir on the pharmacokinetics of BI 1356
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1356 plus ritonavir | Experimental | Drug: BI 1356, Drug: RitonavirTreatment A: 3 days of ritonavir, 1 day BI 1356 |
| BI 1356 | Active comparator | Drug: BI 1356Treatment B: BI 1356 alone |
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 tests
- Age ≥ 18 and Age ≤ 50 years
- BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
Key exclusion criteria (24 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
- Surgery of the gastrointestinal tract (except appendectomy)
- 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 |
|---|---|---|
| BI 1356 | Drug | BI 1356, BI 1356 plus ritonavir |
| RitonavirAlso: Norvir® | Drug | BI 1356 plus ritonavir |
Primary outcome
AUC0-24 (Area under the concentration-time curve of BI 1356 in plasma over the time interval from 0 to 24 hours)
Time frame: up to 24 hours after start of treatment
Cmax (Maximum measured concentration of BI 1356 in plasma)
Time frame: up to 96 hours after start of treatment
13 secondary outcomes
AUC (Area under the concentration time curve of the analytes in plasma at different time points)
Time frame: up to 96 hours after start of treatment
%AUCtz-∞ (Percentage of the extrapolated part of the area under the concentration time curve of the analytes in plasma from 0 to infinity)
Time frame: up to 96 hours after start of treatment
tmax (Time from dosing to the maximum concentration of the analytes in plasma)
Time frame: up to 96 hours after start of treatment
t1/2 (Terminal half-life of the analytes in plasma)
Time frame: up to 96 hours after start of treatment
λz (Terminal rate constant of the analytes in plasma)
Time frame: up to 96 hours after start of treatment
MRTpo (Mean residence time in the body after po administration of the analytes in plasma)
Time frame: up to 96 hours after start of treatment
CL/F (Apparent clearance of BI 1356 in plasma after extravascular administration )
Time frame: up to 96 hours after start of treatment
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) of BI 1356
Time frame: up to 96 hours after start of treatment
Aet1-t2 (Amount of the analytes that is eliminated in urine from the time interval t1 to t2)
Time frame: up to 24 hours after start of treatment
fet1-t2 (Fraction of BI 1356 excreted unchanged in urine from time point t1 to t2)
Time frame: up to 24 hours after start of treatment
CLR,t1-t2 (Renal clearance of the analytes in plasma)
Time frame: up to 24 hours after start of treatment
Cmax (Maximum measured concentration of CD 1750 in Plasma)
Time frame: up to 96 hours after start of treatment
Number of patients with adverse events
Time frame: up to 53 days
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 8 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 BI 1356 and Ritonavir 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 24 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 8 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?
AUC0-24 (Area under the concentration-time curve of BI 1356 in plasma over the time interval from 0 to 24 hours) (time frame: up to 24 hours after start of treatment). 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 8 Jul 2014.