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

NCT02211157 | Completed Phase 1

• 1 other identifier: 1175.3
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating multiple doses with and without a 64 g fat breakfast at the 50 mg dose level

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of patients with clinically relevant changes in laboratory parameters

  up to day 16

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

  up to day 16

• Number of patients with adverse events

  up to 30 days

• Assessment of tolerability on a 4-point scale

  day 16

• Number of patients with clinically relevant changes in vital signs

  up to 16 days

Secondary Outcomes (12)

• Maximum plasma concentration (Cmax) for several time points

  up to day 9

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

  up to day 9

• Time to maximum concentration (tmax)

  up to day 9

• Elimination rate constant (λz)

  up to day 9

• Terminal half-life (t1/2)

  up to day 9

Study Arms (3)

BIBR 796 BS, fasted

EXPERIMENTAL

dose escalation

Drug: BIBR 796 BS

BIBR 796 BS, fed

EXPERIMENTAL

50 mg BIRB 796 BS (food effect)

Drug: BIBR 796 BS; Other: high fat breakfast

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIBR 796 BS DRUG

BIBR 796 BS, fasted; BIBR 796 BS, fed

Placebo DRUG

Placebo

high fat breakfast OTHER

BIBR 796 BS, fed

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%

You may not qualify if:

• Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• History of orthostatic hypotension, fainting spells and blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• 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 drugs with a long half-life (\>24 hours) within 1 month prior to administration or during the trial)
• Use of any drugs which might influence the results of the trial within 10 days prior to administration or during trial
• Participation in another trial with an investigational drug within 2 months prior to administration or during trial
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse (\> 60 g/day)
• Drug abuse
• Blood donation \> 400 ml within 1 month prior to administration or 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 5, 2014
• First Posted: August 7, 2014
• Study Start: March 1, 2000
• Primary Completion: July 1, 2000
• Last Updated: August 8, 2014

Record last verified: 2014-08