Single Rising Oral Doses of BI 10773 in Healthy Male Volunteers

NCT02182453 | Completed Phase 1

• 1 other identifier: 1245.5
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 10773 administered to healthy Japanese male subjects with single rising oral doses (1, 5, 10, 25, and 100 mg).

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of patients with adverse events

  Up to 7 days

• Number of patients with abnormal changes in laboratory parameters

  Baseline, day 2-4 and day 7

• Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate, and body temperature)

  Baseline, day 1-4 and day 7

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

  Baseline, day 1-4 and day 7

• Assessment of tolerability on a 4-point scale

  Day 4

Secondary Outcomes (13)

• Cmax (maximum concentration of the analyte in plasma)

  Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug

• tmax (time from dosing to maximum concentration)

  Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug

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

  Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug

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

  Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug

• 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)

  Before and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 72 hours after administration of study drug

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: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers who meet the following criteria:
• Without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead ECG, and laboratory test results
• Age ≥20 and Age ≤35 years
• Body Mass Index (BMI) ≥18.0 and ≤25.0 kg/m2
• Persons who are willing to participate in this trial and who give their written consent before study initiation in accordance with the Good Clinical Practice (GCP)

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate, body temperature, 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 a 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 before administration of the investigational product or during the trial
• Use of any drugs within 10 days before administration of the investigational product or during the trial
• Participation in another trial with an investigational drug within four months before administration of the investigational product or during the trial
• Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse
• 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: July 2, 2014
• First Posted: July 8, 2014
• Study Start: June 1, 2008
• Primary Completion: August 1, 2008
• Last Updated: July 18, 2014

Record last verified: 2014-07