Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses and Multiple Rising Oral Doses of BI 1356 BS in Healthy Male Volunteers

NCT02183311 | Completed Phase 1

• 1 other identifier: 1218.11
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to examine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356 BS administered to healthy male volunteers at single rising oral doses (1 mg, 2.5 mg, 5 mg, and 10 mg) and at multiple rising oral doses (2.5 mg, 5 mg, and 10 mg once daily for 12 days)

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of patients with abnormal findings in physical examination

  Screening, up to 28 days

• Number of patients with clinically significant changes in Vital signs (blood pressure [BP], pulse rate [PR])

  Screening, up to 28 days

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

  Screening, up to 28 days

• Number of patients with abnormal changes in laboratory parameters

  Screening, up to 28 days

• Number of patients with adverse events

  up to 49 days

Secondary Outcomes (23)

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

  up to 192 h (single dose), up to 456 h (multiple dose)

• tmax (time from dosing to maximum measured concentration)

  up to 192 h (single dose), up to 456 h (multiple dose)

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

  up to 192 h (single dose), up to 456 h (multiple dose)

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

  up to 192 h (single dose), up to 456 h (multiple dose)

• 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 analyte plasma concentration)

  up to 192 h (single dose), up to 456 h (multiple dose)

Study Arms (3)

BI 1356 BS - single rising dose

EXPERIMENTAL

Drug: BI 1356 BS - single rising dose

BI 1356 BS - multiple rising dose

EXPERIMENTAL

Drug: BI 1356 BS - multiple rising dose

Placebo

ACTIVE COMPARATOR

Drug: Placebo

Interventions

BI 1356 BS - single rising dose DRUG

BI 1356 BS - single rising dose

BI 1356 BS - multiple rising dose DRUG

BI 1356 BS - multiple 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:

• Subjects will be healthy male volunteers who meet the criteria below: Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure (BP), pulse rate (PR), and body temperature), 12-lead Electrocardiogram (ECG), and laboratory test results
• Persons who are 20 or older and 35 or younger
• Persons with a BMI 17.6 kg/m2 or more and 29.9 kg/m2 or less
• Persons who are willing to participate in this trial before study initiation and who give their written consent in accordance with GCP (Good Clinical Practice, MHW Ordinance No. 28 dated March 27, 1997)

You may not qualify if:

• Persons who deviate from the norm and who show clinical findings (BP, PR, and ECG) on consultation
• Persons with any clinically relevant complications
• Persons with gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immune, or hormonal disorders
• Persons with central nervous system disorders (e.g., epilepsy), mental disorders, or neurological disorders
• Persons with a history of significant orthostatic hypotension, syncopal attacks, or blackouts
• Persons with chronic infection or severe acute infection
• Persons with a history of severe allergy/hypersensitivity including allergies to drugs and inactive ingredients
• Persons who will have received a drug with a long half-life (more than 24 hours) within the month before treatment in this trial, within a period 10 times longer than the half-life of each drug, or during the study
• Persons who will have received a drug that may theoretically affect the study results based on the information obtained at the time of preparation of the protocol within the 10 days before treatment or during the study
• Persons who will have participated in another trial of an investigational drug within the 4 months before treatment or during the study
• Smokers (who smoke more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Persons who cannot abstain from smoking throughout the study
• Persons who undoubtedly abuse alcohol
• Persons who abuse drugs
• Persons who donate blood of 100 mL or more within the 4 weeks before treatment

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: June 1, 2006
• Primary Completion: October 1, 2006
• Last Updated: July 8, 2014

Record last verified: 2014-07