Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BIRB 1017 BS as a Solution in PEG 400 / 26% Ethanol Administered to Healthy Male Subjects

NCT02184338 | Completed Phase 1

• 1 other identifier: 1187.1
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess safety, tolerability and pharmacokinetics of BIRB 1017 BS in single rising oral doses of 5 to 800 mg in a polyethylene glycol 400 (PEG 400) / 26% ethanol solution in healthy male subjects

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Assessment of safety and tolerability by the investigator on a 4-point scale

  at day 5-10

• Number of patients with adverse events

  up to 25 days

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

  up to day 10

• Number of patients with abnormal changes in clinical laboratory tests

  up to day 10

• Number of patients with clinically relevant effect on electrocardiogram parameters

  up to day 10

Secondary Outcomes (9)

• Maximum concentration of BIRB 1017 BS in plasma (Cmax)

  pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 15:00, 24:00, 34:00, and 48:00 hours after administration of study drug

• Time from dosing to maximum concentration (tmax)

  pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 15:00, 24:00, 34:00, and 48:00 hours after administration of study drug

• Area under the concentration-time curve of the analyte in plasma ofer the time interval from 0 to the last quantifiable analyte plasma concentration (AUC0-infinity)

  pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 15:00, 24:00, 34:00, and 48:00 hours after administration of study drug

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration (AUC0-tz)

  pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 15:00, 24:00, 34:00, and 48:00 hours after administration of study drug

• Terminal elimination rate constant in plasma (λz)

  pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 15:00, 24:00, 34:00, and 48:00 hours after administration of study drug

Study Arms (2)

BIRB 1017 BS in single rising doses

EXPERIMENTAL

Drug: BIBR 1017 BS powder

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIBR 1017 BS powder DRUG

BIRB 1017 BS in single rising doses

Placebo DRUG

PEG 400

Placebo

Eligibility Criteria

• Age: 18 Years - 50 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 \<= 50 years
• BMI \>18.5 and \<29.9 kg/m2 (Body Mass Index)

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, haematological, oncological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• Relevant 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 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 study drug administration or expected during the trial)
• Participation in another trial with an investigational drug (\< 2 months prior to administration or expected during trial)
• Smoker (\> 10 cigarettes or \>3 cigars or \>3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (\> 60 g/day)
• Drug abuse
• Blood donation or loss \> 400 mL, \< 1 month prior to administration or expected 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: July 8, 2014
• First Posted: July 9, 2014
• Study Start: August 1, 2004
• Primary Completion: November 1, 2004
• Last Updated: July 14, 2014

Record last verified: 2014-07