Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 14332 CL Powder in Healthy Male Subjects

NCT02211989 | Completed Phase 1

• 1 other identifier: 1233.1
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate safety, tolerability and pharmacokinetics, and pharmacodynamics of BI 14332 CL

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of patients with adverse events

  up to day 16

• Number of patients with clinically significant findings in vital signs (blood pressure, heart rate)

  up to day 16

• Number of patients with clinically significant findings ECG

  up to day 16

• Number of patients with clinically significant findings laboratory tests

  up to day 16

• Assessment of global tolerability by investigator on a 4-point scale

  within 9 to 16 days after drug administration

Secondary Outcomes (14)

• Cmax (maximum concentration of the analyte in plasma)

  up to 192 hours after drug administration

• tmax (time from dosing to maximum concentration)

  up to 192 hours after drug administration

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 192 hours after drug administration

• %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)

  up to 192 hours after drug administration

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  up to 192 hours after drug administration

Study Arms (2)

BI 14332 CL

EXPERIMENTAL

single rising dose

Drug: BI 14332 CL

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 14332 CL DRUG

BI 14332 CL

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males were included based on a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, and clinical laboratory tests
• Age ≥18 and Age ≤50 years
• Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

You may not qualify if:

• Any finding of the medical examination (including BP, HR 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)
• 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 reasonably influenced the results of the trial based on the knowledge at the time of protocol preparation within 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
• Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 8, 2014
• Study Start: February 1, 2006
• Primary Completion: April 1, 2006
• Last Updated: August 8, 2014

Record last verified: 2014-08