Single Increasing Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Male Volunteers

NCT02222961 | Completed Phase 1

• 1 other identifier: 600.2
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing doses in healthy young volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of subjects with adverse events

  up to 8 days after drug administration

• Number of subjects with clinically significant findings in vital functions

  blood pressure, pulse rate, respiratory rate, oral body temperature

  up to 8 days after drug administration

• Number of subjects with clinically significant findings in ECG

  up to 8 days after drug administration

• Number of subjects with clinically significant findings in laboratory tests

  up to 8 days after drug administration

Secondary Outcomes (12)

• Maximum concentration in plasma (Cmax)

  up to 32 hours after first drug administration

• Time to maximum concentration in plasma (tmax)

  up to 32 hours after first drug administration

• Terminal half-life (t1/2)

  up to 32 hours after first drug administration

• Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf)

  up to 32 hours after first drug administration

• Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)

  up to 32 hours after first drug administration

Study Arms (2)

BIIR 561 CL

EXPERIMENTAL

Drug: BIIR 561 CL

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIR 561 CL DRUG

BIIR 561 CL

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers
• Age 21 to 50 years
• Broca index from -20% to +20%
• Written informed consent prior to admission to the study

You may not qualify if:

• Medical examination, laboratory tests or ECG judged by the investigator to differ significantly from normal clinical values
• Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Known diseases of the central nervous system (CNS) (such as epilepsy), CNS trauma in their medical history or with psychiatric or neurological disorders
• Known history of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of a drug with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
• Intake of any other drug which might influence the results of the trial during the week previous to the start of the study
• Participation in another study with an investigational drug within the last two months preceding this study
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
• Alcohol use of more than 60 g per day
• Drug dependency
• Excessive physical activities (e.g. competitive sports) within the last week before the study
• Blood donation within the last 4 weeks (\>= 100 ml)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

irampanel

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 22, 2014
• Study Start: November 1, 1999
• Primary Completion: June 1, 2000
• Last Updated: August 22, 2014

Record last verified: 2014-08