- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183441
Bioavailability of BI 1356 After Co-administration With Ritonavir Compared to the Bioavailability of BI 1356 Alone in Healthy Male Volunteers
July 4, 2014 updated by: Boehringer Ingelheim
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Exclusion criteria specific for this study:
- Galactose intolerance
- Lactase deficiency
- Glucose-galactose-malabsorption
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BI 1356 plus ritonavir
Treatment A: 3 days of ritonavir, 1 day BI 1356
|
Other Names:
|
Active Comparator: BI 1356
Treatment B: BI 1356 alone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
up to 96 hours after start of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse events
Time Frame: up to 53 days
|
up to 53 days
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
up to 96 hours after start of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
July 4, 2014
First Submitted That Met QC Criteria
July 4, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Estimate)
July 8, 2014
Last Update Submitted That Met QC Criteria
July 4, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Incretins
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Ritonavir
- Linagliptin
Other Study ID Numbers
- 1218.31
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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