Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered to Healthy Human Subjects

NCT02209805 | Completed Phase 1

• 1 other identifier: 1175.14
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as multiple daily doses at various dose levels.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of patients with clinically significant changes in vital signs

  up to 21 days

• Number of patients with clinically significant changes in laboratory parameters

  up to 21 days

• Number of patients with abnormal findings in electrocardiogram

  up to 21 days

• Number of patients with adverse events

  up to 24 days

Secondary Outcomes (8)

• Maximum concentration of the analyte in plasma (Cmax) for several time points

  up to 36 hours after dosing

• Area under the plasma concentration versus time curve (AUC) for several time points

  up to 36 hours after dosing

• Time at which maximum plasma concentration occurred over a dosing interval (tmax)

  up to 36 hours after dosing

• Terminal elimination rate constant (λZ)

  up to 36 hours after dosing

• Elimination half-life (t1/2)

  up to 36 hours after dosing

Study Arms (4)

BIRB 796 BS, low dose

EXPERIMENTAL

Drug: BIRB 796 BS, low dose

BIRB 796 BS, high dose

EXPERIMENTAL

Drug: BIRB 796 BS, high dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

BIRB 796 BS, medium dose

EXPERIMENTAL

Drug: BIRB 796 BS, low dose; Drug: BIRB 796 BS, high dose

Interventions

BIRB 796 BS, low dose DRUG

BIRB 796 BS, low dose; BIRB 796 BS, medium dose

BIRB 796 BS, high dose DRUG

BIRB 796 BS, high dose; BIRB 796 BS, medium dose

Placebo DRUG

Placebo

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 and local legislation
• Age \>= 18 and \<= 45 years
• Broca \>= - 20 % and \<= + 20%
• Able to communicate well with the investigator and to comply with study requirements
• \> 10 elimination half lives present since last use of any investigational drug for that investigational drug
• Laboratory values within a clinically relevant reference range

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate, temperature, and EKG) 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 to the trial as judged by the investigator
• History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)
• 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 (\< 1 months prior to administration or during trial)
• Smoker
• Inability to refrain from smoking on trial days
• Alcohol abuse (\> 60 g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

doramapimod

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 5, 2014
• First Posted: August 6, 2014
• Study Start: January 1, 2001
• Primary Completion: March 1, 2001
• Last Updated: August 6, 2014

Record last verified: 2014-08