Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses Oral BIRB 796 BS in Healthy Human Subjects

NCT02208856 | Completed Phase 1

• 1 other identifier: 1175.1
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single doses, with and without a 64 g fat breakfast at one selected dose.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of subjects with clinically relevant changes in vital signs

  Baseline, up to 96 hours after drug administration

• Number of subjects with clinically relevant changes in laboratory measurements

  Baseline, up to 96 hours after drug administration

• Number of subjects with clinically relevant changes in electrocardiograms (ECG)

  Baseline, up to 96 hours after drug administration

• Number of subjects with adverse events

  up to 96 hours after drug administration

Secondary Outcomes (11)

• Maximum concentration of the analyte in plasma (Cmax)

  up to 48 hours after drug administration

• Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC0-inf)

  up to 48 hours after drug administration

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

  up to 48 hours after drug administration

• Terminal rate constant of the analyte in plasma (λz)

  up to 48 hours after drug administration

• Half life of the analyte in plasma (t1/2)

  up to 48 hours after drug administration

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

BIBR 796 BS food effect

EXPERIMENTAL

Drug: BIBR 796 BS; Other: high fat standardized breakfast

BIBR 796 BS

EXPERIMENTAL

Drug: BIBR 796 BS

Interventions

BIBR 796 BS DRUG

BIBR 796 BS; BIBR 796 BS food effect

Placebo DRUG

Placebo

high fat standardized breakfast OTHER

BIBR 796 BS food effect

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
• Age \>= 18 and \<= 45 years
• Broca \>= -20% and \<= +20%

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological 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 ot the trial as judged by the investigator
• Intake of drugs with a long half-life (\> 24 hours) (= 1 month prior to administration or during the trial)
• Use of any drugs, which might influence the results of the trial (= 10 days prior to administration or during the trial)
• Participation in another trial with an investigational drug (=2 months prior to administration or during trial)
• Smoker (\> 10 cigarettes of \> 3 cigars of \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (\> 60 g/day)
• Drug abuse
• Blood donation \> 400 ml (=1 month prior to administration of during the trial)

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: August 4, 2014
• First Posted: August 5, 2014
• Study Start: September 1, 1999
• Primary Completion: December 1, 1999
• Last Updated: August 5, 2014

Record last verified: 2014-08