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

NCT02211144 | Completed Phase 1

• 1 other identifier: 1175.21
• Study Type: interventional
• Target: 120
• 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 (5)

• Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure)

  up to day 21

• Number of patients with clinically relevant changes in laboratory parameters

  up to day 21

• Number of patients with clinical relevant findings in electrocardiogram (ECG)

  up to day 21

• Number of patients with adverse events

  up to 35 days

• Clinical assessment of tolerability on a 4-point scale

  day 21

Secondary Outcomes (10)

• Maximum observed plasma concentration during steady state dosing interval (Cmax,ss)

  up to day 16

• area under the plasma concentration versus time curve at different time points (AUC)

  up to day 16

• Time to the maximum plasma concentration at steady state (tmax,ss)

  up to day 16

• Elimination half-life (t1/2)

  up to day 16

• Terminal elimination rate constant (λz)

  up to day 16

Study Arms (2)

BIRB 796 BS

EXPERIMENTAL

in escalating doses

Drug: BIBR 796 BS; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIBR 796 BS DRUG

BIRB 796 BS

Placebo DRUG

BIRB 796 BS; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects as determined by results of screening
• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Female subjects who were not lactating and not of child bearing potential as defined by surgically sterile or post menopausal (no periods for at least 12 months and elevated follicle stimulating hormone (FSH) with low estradiol while on no estrogen supplementation). Females were to use barrier contraception (e.g. condoms) prior to administration of study medication, during the study and at least one month after release from the study. Women must have had negative blood pregnancy tests
• Age ≥ 18 and ≤ 60 years
• Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
• Able to communicate well with the investigator and to comply with study requirements
• Laboratory values within a clinically defined reference range

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic 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 (at least 10 times the relevant elimination half-life) or during the trial)
• Having had prescription medication 2 weeks prior to study drug administration or over the counter medication 1 week prior to study drug administration (at least 10 times the relevant elimination half-life)
• Smoker
• Alcohol abuse (\> 60 g/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: August 5, 2014
• First Posted: August 7, 2014
• Study Start: March 1, 2002
• Primary Completion: November 1, 2002
• Last Updated: August 7, 2014

Record last verified: 2014-08