Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 44370 TA Tablets in Healthy Male and Female Volunteers

NCT02215759 | Completed Phase 1

• 1 other identifier: 1246.15
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluation of safety, tolerability and pharmacokinetics of multiple rising oral doses of BI 44370 TA in healthy male and female volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of patients with adverse events

  up to 36 days

• Number of patients with clinically relevant findings in vital signs

  up to 7 days after last drug administration

• Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram)

  up to 7 days after last drug administration

• Number of patients with clinically relevant laboratory findings

  up to 7 days after last drug administration

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

  up to 7 days after last drug administration

Secondary Outcomes (16)

• Maximum measured concentration of the analyte in plasma (Cmax ) for several time points

  up to 4 days

• Time from dosing to maximum measured concentration of the analyte in plasma (tmax) for several time points

  up to 4 days

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC) for several time points

  up to 4 days

• The percentage of the AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞) for several time points

  up to 4 days

• Terminal rate constant in plasma (λz) for several time points

  up to 4 days

Study Arms (2)

BI 44370 TA

EXPERIMENTAL

Drug: BI 44370 TA

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 44370 TA DRUG

BI 44370 TA

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy males and females according to the following criteria based upon a complete medical history, including the physical examination, vital signs, 12-lead ECG, clinical laboratory tests
• Age ≥21 and Age ≤50 year
• BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

You may not qualify if:

• Any finding of the medical examination (including vital signs 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
• 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
• Smoking (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 40 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: January 1, 2009
• Primary Completion: June 1, 2009
• Last Updated: August 13, 2014

Record last verified: 2014-08