Clinical trial NCT01343719: Single Rising Dose Study to Assess Safety, Tolerability and Pharmacokinetics of BI 661051.
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-04-28
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: Purpose:

Eligibility criteria: Inclusion criteria:

1. 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.
2. Age =18 and age =50 years.
3. BMI =18.5 and BMI =30 kg/m2 (Body Mass Index).
4. 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:

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance.
2. Any evidence of a clinically relevant concomitant disease.
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
5. History of relevant orthostatic hypotension, fainting spells or blackouts.
6. Chronic or relevant acute infections.
7. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) as judged clinically relevant by the investigator.
8. 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.
9. 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.
10. Participation in another trial with an investigational drug within 30 days prior to randomisation.
11. Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day).
12. Inability to refrain from smoking on trial days as judged by the investigator.
13. Alcohol abuse (more than 30 g/day).
14. Drug abuse.
15. Blood donation (more than 100 mL within 4 weeks prior to randomisation or during the trial).
16. Excessive physical activities (within 1 week prior to randomisation or during the trial).
17. Any laboratory value outside the reference range that is of clinical relevance.
18. Inability to comply with dietary regimen of the study centre.

Primary outcomes:
measure: Occurrence of findings of physical examination
timeFrame: 14 weeks
measure: Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate [RR])
timeFrame: 14 weeks
measure: Orthostasis test parameters
timeFrame: 14 weeks
measure: Body temperature
timeFrame: 14 weeks
measure: 12-lead electrocardiogram (ECG) parameters (heart rate, PQ interval, QRS interval, uncorrected QT interval as well as Bazett- and Fridericia corrected QT interval)
timeFrame: 14 weeks
measure: Clinical laboratory test parameters (haematology, clinical chemistry and urinalysis parameters)
timeFrame: 14 weeks
measure: Occurrence of adverse events (AEs) on the level of Medical Dictionary for Regulatory Affairs (MedDRA) Preferred Terms and MedDRA System Organ Class
timeFrame: 14 weeks
measure: Occurrence of findings detected by the pupillometry measurements
timeFrame: 14 weeks
measure: Tolerability assessed by investigator
timeFrame: 14 weeks
Secondary outcomes:
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: 14 weeks
measure: AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: 14 weeks
measure: 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)
timeFrame: 14 weeks
measure: Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: 1296.1.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: