- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01343719
Single Rising Dose Study to Assess Safety, Tolerability and Pharmacokinetics of BI 661051.
A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Phase I Study to a) Assess Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of 2 mg to 350 mg of BI 661051 Administered as Oral Drinking Solution (Powder in Bottle) in Healthy Male Volunteers, b) to Explore the Relative Oral Bioavailability of a Tablet Formulation and c) to Assess the Impact of a High Fat Meal on the Oral Bioavailability of the Oral Drinking Solution (Powder in Bottle)
The objective of the current study is to investigate safety, tolerability, and pharmacokinetics of treatment with BI 661051 rising single doses administered as oral drinking solution (powder in bottle) in healthy male subjects.
The primary objective is to investigate the safety and tolerability of treatment with BI 661051.
The secondary objectives are (1) to evaluate the single dose pharmacokinetics of BI 661051, (2) to explore dose proportionality, (3) to explore the relative bioavailability when BI 661051 is administered as tablet at two dose levels compared to oral drinking solution and (4) to assess the effect on the bioavailability when BI 661051 is administered as oral drinking solution after intake of a high fat meal.
Pharmacodynamic parameters will not be determined within this study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Mannheim, Germany
- 1296.1.1 Boehringer Ingelheim Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Healthy males 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. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
- Age =18 and age =50 years.
- BMI =18.5 and BMI =30 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.
- 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) as judged clinically relevant by the investigator.
- Intake of drugs with a long half-life (>24 h) within at least 1 month or less than 10 half-lives of the respective drug prior to administration.
- 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 randomisation.
- Participation in another trial with an investigational drug within 30 days prior to randomisation.
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day).
- Inability to refrain from smoking on trial days as judged by the investigator.
- Alcohol abuse (more than 30 g/day).
- Drug abuse.
- Blood donation (more than 100 mL within 4 weeks prior to randomisation or during the trial).
- Excessive physical activities (within 1 week prior to randomisation or during the trial).
- Any laboratory value outside the reference range that is of clinical relevance.
- Inability to comply with dietary regimen of the study centre.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BI 661051 low dose, low
solution for oral administration, single dose
|
medium dose solution for oral administration
low dose solution for oral administration
high dose solution for oral administration
low dose tablet
medium dose tablet
|
Experimental: BI 661051 low dose, medium
solution for oral administration, single dose
|
medium dose solution for oral administration
low dose solution for oral administration
high dose solution for oral administration
low dose tablet
medium dose tablet
|
Experimental: BI 661051 low dose, high
solution for oral administration, single dose
|
medium dose solution for oral administration
low dose solution for oral administration
high dose solution for oral administration
low dose tablet
medium dose tablet
|
Experimental: BI 661051 medium dose, low
solution for oral administration, single dose
|
medium dose solution for oral administration
low dose solution for oral administration
high dose solution for oral administration
low dose tablet
medium dose tablet
|
Experimental: BI 661051 medium dose, medium
solution for oral administration, single dose
|
medium dose solution for oral administration
low dose solution for oral administration
high dose solution for oral administration
low dose tablet
medium dose tablet
|
Experimental: BI 661051 medium dose, high
solution for oral administration, single dose
|
medium dose solution for oral administration
low dose solution for oral administration
high dose solution for oral administration
low dose tablet
medium dose tablet
|
Experimental: BI 661051 high dose, low
solution for oral administration, single dose
|
medium dose solution for oral administration
low dose solution for oral administration
high dose solution for oral administration
low dose tablet
medium dose tablet
|
Experimental: BI 661051 high dose, medium
solution for oral administration, single dose
|
medium dose solution for oral administration
low dose solution for oral administration
high dose solution for oral administration
low dose tablet
medium dose tablet
|
Experimental: BI 661051 low dose
tablet
|
medium dose solution for oral administration
low dose solution for oral administration
high dose solution for oral administration
low dose tablet
medium dose tablet
|
Experimental: BI 661051 medium dose
tablet
|
medium dose solution for oral administration
low dose solution for oral administration
high dose solution for oral administration
low dose tablet
medium dose tablet
|
Placebo Comparator: Placebo
solution for oral administratrion
|
solution for administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of findings of physical examination
Time Frame: 14 weeks
|
14 weeks
|
Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate [RR])
Time Frame: 14 weeks
|
14 weeks
|
Orthostasis test parameters
Time Frame: 14 weeks
|
14 weeks
|
Body temperature
Time Frame: 14 weeks
|
14 weeks
|
12-lead electrocardiogram (ECG) parameters (heart rate, PQ interval, QRS interval, uncorrected QT interval as well as Bazett- and Fridericia corrected QT interval)
Time Frame: 14 weeks
|
14 weeks
|
Clinical laboratory test parameters (haematology, clinical chemistry and urinalysis parameters)
Time Frame: 14 weeks
|
14 weeks
|
Occurrence of adverse events (AEs) on the level of Medical Dictionary for Regulatory Affairs (MedDRA) Preferred Terms and MedDRA System Organ Class
Time Frame: 14 weeks
|
14 weeks
|
Occurrence of findings detected by the pupillometry measurements
Time Frame: 14 weeks
|
14 weeks
|
Tolerability assessed by investigator
Time Frame: 14 weeks
|
14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax (maximum measured concentration of the analyte in plasma)
Time Frame: 14 weeks
|
14 weeks
|
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time Frame: 14 weeks
|
14 weeks
|
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration)
Time Frame: 14 weeks
|
14 weeks
|
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time Frame: 14 weeks
|
14 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1296.1
- 2010-022465-96 (EudraCT Number: EudraCT)
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