Safety, Tolerability and Pharmacokinetics of Increasing Repeated Doses of BIIF 1149 BS in Healthy Male Volunteers

NCT02203487 | Completed Phase 1

• 1 other identifier: 1157.3
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the present study was to obtain information about the safety and tolerability of BIIF 1149 BS after repeated dosing and to obtain preliminary pharmacokinetics data (steady state and accumulation factor)

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Number of subjects with adverse events

  up to 55 days

• Number of subjects with abnormal changes in laboratory parameters

  up to 8 days after last blood sample

• Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)

  up to 8 days after last blood sample

Secondary Outcomes (13)

• Number of subjects with clinically significant changes in 12-lead Electrocardiogram (ECG)

  up to 8 days after last blood sample

• Cmax (Maximum concentration of the analyte in plasma)

  up to 360 hours after last drug administration

• Tmax (Time to maximum observed concentration of the analyte in plasma)

  up to 360 hours after last drug administration

• AUC (Area under the concentration-time curve of the analyte in plasma)

  up to 360 hours after last drug administration

• Ae (Urinary excretion of parent drug)

  up to 120 hours after last drug administration

Study Arms (2)

BIIF 1149 BS - single rising dose

EXPERIMENTAL

Drug: BIIF 1149 BS - single rising dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIF 1149 BS - single rising dose DRUG

BIIF 1149 BS - single rising dose

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Participants should be healthy males
• Age range from 21 to 50 years
• Within +- 20% of their normal weight (Broca-Index)
• In accordance with Good Clinical Practice (GCP) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study

You may not qualify if:

• Haematopoietic, hepatic and renal function test will be carried out in the laboratory
• The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
• Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
• Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of a drug with a long half-life (\>= 24 hours) within ten half-lives of the respective drug before enrolment in the study
• Use of any other drugs which might influence the results of the trial during the week previous to the start of the study
• Participation in another study with an investigational drug within the last two months preceding this study
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse (\> 40g/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: July 29, 2014
• First Posted: July 30, 2014
• Study Start: November 1, 1999
• Primary Completion: June 1, 2000
• Last Updated: July 30, 2014

Record last verified: 2014-07