Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 10773 in Healthy Male Subjects

NCT02172170 | Completed Phase 1

• 1 other identifier: 1245.1
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses of BI 10773 to healthy male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of patients with adverse events

  up to 33 days

• Number of patients with clinically significant changes in vital signs

  up to 12 days

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

  up to day 4

• Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)

  up to 12 days

• Number of patients with abnormal findings in physical examination

  up to 12 days

• Number of patients with abnormal changes in laboratory parameters

  up to 12 days

Secondary Outcomes (13)

• Cmax (maximum concentration of the analyte in plasma)

  up to 72 hours after drug administration

• tmax (time from dosing to maximum 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 (2)

BI 10773 single rising dose

EXPERIMENTAL

Drug: BI 10773 single rising dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 10773 single rising dose DRUG

BI 10773 single rising dose

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 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
• Age ≥ 18 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 (GCP) and the local legislation

You may not qualify if:

• Any finding of the medical examination including ((blood pressure (BP), pulse rate (PR), 12-lead 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: June 20, 2014
• First Posted: June 24, 2014
• Study Start: January 1, 2007
• Primary Completion: March 1, 2007
• Last Updated: June 24, 2014

Record last verified: 2014-06