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Single Rising Dose Study to Assess Safety, Tolerability and Pharmacokinetics of BI 661051.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01343719
First received: April 19, 2011
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: BI 661051
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Occurrence of findings of physical examination [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate [RR]) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Orthostasis test parameters [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Body temperature [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Clinical laboratory test parameters (haematology, clinical chemistry and urinalysis parameters) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Occurrence of findings detected by the pupillometry measurements [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Tolerability assessed by investigator [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: April 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 661051 low dose, low
solution for oral administration, single dose
Drug: BI 661051
low dose solution for oral administration
Experimental: BI 661051 low dose, medium
solution for oral administration, single dose
Drug: BI 661051
low dose solution for oral administration
Experimental: BI 661051 low dose, high
solution for oral administration, single dose
Drug: BI 661051
low dose solution for oral administration
Experimental: BI 661051 medium dose, low
solution for oral administration, single dose
Drug: BI 661051
medium dose solution for oral administration
Experimental: BI 661051 medium dose, medium
solution for oral administration, single dose
Drug: BI 661051
medium dose solution for oral administration
Experimental: BI 661051 medium dose, high
solution for oral administration, single dose
Drug: BI 661051
medium dose solution for oral administration
Experimental: BI 661051 high dose, low
solution for oral administration, single dose
Drug: BI 661051
high dose solution for oral administration
Experimental: BI 661051 high dose, medium
solution for oral administration, single dose
Drug: BI 661051
high dose solution for oral administration
Experimental: BI 661051 low dose
tablet
Drug: BI 661051
low dose tablet
Experimental: BI 661051 medium dose
tablet
Drug: BI 661051
medium dose tablet
Placebo Comparator: Placebo
solution for oral administratrion
Drug: Placebo
solution for administration

Detailed Description:

Purpose:

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343719

Locations
Germany
1296.1.1 Boehringer Ingelheim Investigational Site
Mannheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01343719     History of Changes
Other Study ID Numbers: 1296.1, 2010-022465-96
Study First Received: April 19, 2011
Last Updated: October 30, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014