Safety Tolerability and Pharmacokinetic of BI 409306

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01343706
First received: April 6, 2011
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy male genotyped volunteers following oral administration of single rising doses.

The secondary objectives are: (1) to explore dose proportionality of BI 409306 as immediate release solid oral dosage, (2) to explore the relative bioavailability of BI 409306 when administered as immediate release solid oral dosage compared to oral drinking solution and (3) to compare the safety and pharmacokinetic profiles between two different groups of genotyped subjects.


Condition Intervention Phase
Healthy
Drug: Placebo
Drug: Placebo .
Drug: BI 409306
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled (Within Dose Groups) Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Doses 0.5 mg to 500 mg of BI 409306 Administered Orally in Healthy Male Volunteers

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Physical examination (respiratory, gastro-intestinal, musculoskeletal) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • 12-lead ECG (electrocardiogram) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory tests (haematology: haemoglobin; haematocrit/erythrocytes; haemoglobin/erythroctes; Erythro-, leuco-,lympho-, mono-Cytes; Platelets) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Assessment of tolerability by investigator [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory tests (clinical chemistry: electrolytes;liver enzymes, bilirubin, amylase, lipase, cholesterol) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory tests (urinanalysis: pH, nitrite, protein, glucose, ketones, red blood cells, white blood cells, bacteria, crystals) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in Bond-Lader Visual Analogue Scales [ Time Frame: Up to 24 h after drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 18 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: 18 weeks ] [ Designated as safety issue: No ]
  • AUC0-tz (area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point) [ Time Frame: 18 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: 18 weeks ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: April 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 409306 low dose
Solution for oral administration
Drug: BI 409306
low dose solution for oral administration
Experimental: BI 409306 low dose
Solution for oral administration
Drug: BI 409306
low dose solution for oral administration
Experimental: BI 409306 lowdose
Solution for oral administration
Drug: BI 409306
low dose solution for oral administration
Experimental: BI 409306 medium dose
Solution for oral administration
Drug: BI 409306
medium dose solution for oral administration
Experimental: BI 409306 low dose
Immediate release solid oral dosage
Drug: BI 409306
Immediate release solid oral dosage low
Experimental: BI 409306 medium dose
Immediate release solid oral dosage
Drug: BI 409306
Immediate release solid oral dosage medium
Experimental: BI 409306 medium dose
Immediate release solid oral dosage
Drug: BI 409306
Immediate release solid oral dosage medium
Experimental: BI 409306 medium dose
Immediate release solid oral dosage
Drug: BI 409306
Immediate release solid oral dosage medium
Experimental: BI 409306 high dose
Immediate release solid oral dosage
Drug: BI 409306
Immediate release solid oral dosage high
Experimental: BI 409306 high dose
Immediate release solid oral dosage
Drug: BI 409306
Immediate release solid oral dosage high
Experimental: BI 409306 high dose
Immediate release solid oral dosage
Drug: BI 409306
Immediate release solid oral dosage high
Experimental: BI 409306 high dose
Immediate release solid oral dosage
Drug: BI 409306
Immediate release solid oral dosage high
Experimental: Placebo
Solution for oral administration
Drug: Placebo
Solution for oral administration
Experimental: Placebo .
Immediate release solid oral dosage
Drug: Placebo .
Immediate release solid oral dosage

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. 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
  2. Age > 21 and Age < 50 years
  3. Body Mass Index (BMI) > 18.5 and BMI < 29.9 kg/m2

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. Surgery of the gastrointestinal tract (except appendectomy)
  5. Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month
  6. History of relevant orthostatic hypotension, fainting spells or blackouts.
  7. Chronic or relevant acute infections
  8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  9. Use of drugs which might reasonably influence the results of the trial or that 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
  10. Any laboratory value outside the reference range that is of clinical relevance
  11. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
  12. A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  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: NCT01343706

Locations
Germany
1289.1.1 Boehringer Ingelheim Investigational Site
Ingelheim, 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: NCT01343706     History of Changes
Other Study ID Numbers: 1289.1, 2010-023604-27
Study First Received: April 6, 2011
Last Updated: October 31, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on October 01, 2014