Safety, Tolerability and Pharmacokinetics of BI 34021 FU2 Oral Drinking Solution in Healthy Male Volunteers

NCT02259842 | Completed Phase 1

• 1 other identifier: 1258.1
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluation of safety, tolerability and PK of single rising oral doses of BI 34021 FU2 in healthy male volunteers; comparison of 100 mg drinking solution vs. tablet, assessment of food effect by re-dosing at 50 mg and 150 mg

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Number of participants with clinically significant findings on physical examination

  up to 10 days after last drug administration

• Number of participants with clinically significant findings in vital signs

  blood pressure (BP), pulse rate (PR) respiratory rate (RR), oral body temperature, orthostatic test

  up to 10 days after last drug administration

• Number of participants with clinically significant findings in 12-lead electrocardiogram (ECG)

  up to 10 days after last drug administration

• Number of participants with clinically significant findings in laboratory tests

  up to 10 days after last drug administration

• Number of participants with clinically significant findings in safety markers

  laboratory results for kidney and liver function

  up to 10 days after last drug administration

• Number of participants with adverse events

  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 (14)

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

  up to 72 hours after last drug administration

• tmax (time from dosing to maximum measured concentration)

  up to 72 hours after last 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 last drug administration

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

  up to 72 hours after last 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 last drug administration

Study Arms (3)

BI 34021 FU2 solution

EXPERIMENTAL

single rising doses, dose groups 3 and 5 double-dosing (fed and fasted)

Drug: BI 34021 FU2 solution; Other: High fat, high calorie breakfast

BI 34021 FU2 tablet

EXPERIMENTAL

dose group 4 only

Drug: BI 34021 FU2 tablet

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 34021 FU2 solution DRUG

BI 34021 FU2 solution

BI 34021 FU2 tablet DRUG

dose group 4 only

BI 34021 FU2 tablet

Placebo DRUG

Placebo

High fat, high calorie breakfast OTHER

only for dose groups 3 and 5

BI 34021 FU2 solution

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), 12-lead ECG, clinical laboratory tests
• Age ≥21 and Age ≤50 years
• 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 BP, PR 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
• 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: October 6, 2014
• First Posted: October 9, 2014
• Study Start: March 1, 2008
• Primary Completion: June 1, 2008
• Last Updated: October 9, 2014

Record last verified: 2014-10