Safety, Tolerability and Pharmacokinetics of BI 44370 TA Oral Drinking Solution in Healthy Male Volunteers

NCT02215018 | Completed Phase 1

• 1 other identifier: 1246.1
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety, tolerability and pharmacokinetics of single rising oral doses of BI 44370 TA in healthy male volunteers, to compare a drinking solution vs. a tablet formulation and to assess intra-individual pharmacokinetic (PK) variability by re-dosing two further doses.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of patients with adverse events

  up to 10 days after last drug administration

• Number of patients with clinically significant findings in vital signs

  up to 10 days after last drug administration

• Number of patients with clinically significant findings in laboratory tests

  up to 10 days after last drug administration

• Number of patients with clinically significant findings in ECG

  up to 10 days after last drug administration

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

  up to 10 days after last drug administration

Secondary Outcomes (15)

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 72 hours after drug administration

• tmax (time from dosing to maximum measured concentration)

  up to 72 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 72 hours after drug administration

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

  up to 72 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 72 hours after drug administration

Study Arms (4)

BI 44370 TA solution

EXPERIMENTAL

Drug: BI 44370 TA solution

BI 44370 TA tablet

EXPERIMENTAL

Drug: BI 44370 TA tablet

Placebo solution

PLACEBO COMPARATOR

Drug: Placebo solution

Placebo tablet

PLACEBO COMPARATOR

Drug: Placebo tablet

Interventions

BI 44370 TA solution DRUG

BI 44370 TA solution

BI 44370 TA tablet DRUG

BI 44370 TA tablet

Placebo solution DRUG

Placebo solution

Placebo tablet DRUG

Placebo tablet

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (BP, PR, RR and body temperature), 12-lead ECG, clinical laboratory tests
• Age ≥21 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 Good clinical practice (GCP) and the local legislation

You may not qualify if:

• Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate (PR), Respiratory rate (RR) , body temperature and Electrocardiogram(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
• Surgery of the gastrointestinal tract (except appendectomy)
• 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 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
• 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

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 12, 2014
• First Posted: August 13, 2014
• Study Start: April 1, 2007
• Primary Completion: August 1, 2007
• Last Updated: August 13, 2014

Record last verified: 2014-08