Back to resultsBioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
BI 201335 NA 120 mg capsule
BI 201335 NA 120 mg capsule
BI 201335 NA 40 mg capsule
BI 201335 NA 40 mg capsule
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility Criteria
Inclusion criteria:
- Healthy male volunteers without any clinical significant findings and complications
- Age: 20 - 45 years
- BMI: 18.5 - 25.0 kg/m2
- Signed informed consent
Exclusion criteria:
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance.
- Any evidence of a clinically relevant concomitant disease according to investigator's clinical judgement.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- History of jaundice
- 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.
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) according to investigator's clinical judgement.
- 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 (pharmacokinetic) of the trial within at least 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.
- Smoking (>10 cigarettes or >3 cigars or >3 pipes/day).
- Inability to refrain from smoking during the trial.
- Alcohol abuse (more than 60 g/day: e.g., 3 middle-sized bottles of beer, 3 gous [equivalent to 540 mL] of sake).
- Drug abuse.
- Blood donation (more than 100 mL within four weeks prior to administration).
- Excessive physical activities (within one week prior to administration).
- Any laboratory value outside the reference range that is of clinical relevance according to investigator's clinical judgement.
- Any history of relevant liver diseases (for instance, disturbances of liver function, Dubin-Johnson syndrome, Rotor syndrome, or previous liver tumours).
Sites / Locations
- 1220.53.08101 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment sequence 1
Treatment sequence 2
Arm Description
Test - Reference - Reference - Test
Reference - Test - Test - Reference
Outcomes
Primary Outcome Measures
Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point.
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Maximum Measured Concentration (Cmax)
Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Secondary Outcome Measures
Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
Area under the concentration-time curve of faldaprevir in plasma over the time interval from 0 extrapolated to infinity.
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Time From Dosing to the Maximum Measured Concentration (Tmax)
Time from dosing to the maximum measured concentration of the analyte in plasma.
Means presented are adjusted means and the standard deviation is actually the intra-individual coefficient of variation.
Terminal Rate Constant (λz)
Terminal rate constant of the analyte in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Terminal Half-life (t1/2)
Terminal half-life of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Mean Residence Time (MRTpo)
Mean residence time of the analyte in the body after oral administration. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01704846
Brief Title
Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules
Official Title
Assessment of Bioequivalence Between Two Different Formulations of BI 201335 NA Soft Gelatine Capsules in Healthy Male Volunteers. (an Open-label, Randomised, Single-dose, Four-period Replicated Crossover Study)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment sequence 1
Arm Type
Experimental
Arm Description
Test - Reference - Reference - Test
Arm Title
Treatment sequence 2
Arm Type
Experimental
Arm Description
Reference - Test - Test - Reference
Intervention Type
Drug
Intervention Name(s)
BI 201335 NA 120 mg capsule
Intervention Description
1capsule of BI 201335 NA 120 mg capsule
Intervention Type
Drug
Intervention Name(s)
BI 201335 NA 120 mg capsule
Intervention Description
1 capsule of BI 201335 NA 120 mg capsule
Intervention Type
Drug
Intervention Name(s)
BI 201335 NA 40 mg capsule
Intervention Description
3 capsules of BI 201335 NA 40 mg capsule
Intervention Type
Drug
Intervention Name(s)
BI 201335 NA 40 mg capsule
Intervention Description
3 capsules of BI 201335 NA 40 mg capsule
Primary Outcome Measure Information:
Title
Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)
Description
Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point.
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Time Frame
3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Title
Maximum Measured Concentration (Cmax)
Description
Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Time Frame
3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Secondary Outcome Measure Information:
Title
Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
Description
Area under the concentration-time curve of faldaprevir in plasma over the time interval from 0 extrapolated to infinity.
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Time Frame
3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Title
Time From Dosing to the Maximum Measured Concentration (Tmax)
Description
Time from dosing to the maximum measured concentration of the analyte in plasma.
Means presented are adjusted means and the standard deviation is actually the intra-individual coefficient of variation.
Time Frame
3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Title
Terminal Rate Constant (λz)
Description
Terminal rate constant of the analyte in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Time Frame
3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Title
Terminal Half-life (t1/2)
Description
Terminal half-life of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Time Frame
3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Title
Mean Residence Time (MRTpo)
Description
Mean residence time of the analyte in the body after oral administration. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Time Frame
3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Healthy male volunteers without any clinical significant findings and complications
Age: 20 - 45 years
BMI: 18.5 - 25.0 kg/m2
Signed informed consent
Exclusion criteria:
Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance.
Any evidence of a clinically relevant concomitant disease according to investigator's clinical judgement.
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
History of jaundice
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.
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) according to investigator's clinical judgement.
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 (pharmacokinetic) of the trial within at least 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.
Smoking (>10 cigarettes or >3 cigars or >3 pipes/day).
Inability to refrain from smoking during the trial.
Alcohol abuse (more than 60 g/day: e.g., 3 middle-sized bottles of beer, 3 gous [equivalent to 540 mL] of sake).
Drug abuse.
Blood donation (more than 100 mL within four weeks prior to administration).
Excessive physical activities (within one week prior to administration).
Any laboratory value outside the reference range that is of clinical relevance according to investigator's clinical judgement.
Any history of relevant liver diseases (for instance, disturbances of liver function, Dubin-Johnson syndrome, Rotor syndrome, or previous liver tumours).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1220.53.08101 Boehringer Ingelheim Investigational Site
City
Sumida-ku,Tokyo
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
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Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules
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