Increasing Dose Tolerance Study in Healthy Male Volunteers After Administration of BIII 890 CL

NCT02268136 | Terminated Phase 1

• 1 other identifier: 599.1
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective ot the present study is to obtain information about safety, tolerability and preliminary pharmacokinetics of BIII 890 CL after single intravenous administration of increasing doses in healthy male volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of subjects with clinically relevant changes in vital signs

  up to 8 days after drug administration

• Number of subjects with adverse events

  up to 8 days after drug administration

• Number of subjects with clinically relevant changes in electrocardiogram

  up to 8 days after drug administration

• Number of subjects with clinically relevant changes in pharmaco electroencephalogram (EEG)

  up to 24 hours after drug administration

• Number of subjects with clinically relevant changes in laboratory parameters

  up to 8 days after drug administration

Secondary Outcomes (8)

• Maximum plasma concentration (Cmax)

  up to 24 hours after drug administration

• Time to reach Cmax (tmax)

  up to 24 hours after drug administration

• Terminal half-life (t1/2)

  up to 24 hours after drug administration

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

  up to 24 hours after drug administration

• Mean residence time (MRT)

  up to 24 hours after drug administration

Study Arms (2)

BIII 890 CL

EXPERIMENTAL

single increasing doses

Drug: BIII 890 CL

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIII 890 CL DRUG

BIII 890 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 subjects as determined by results of screening
• Age ≥ 21 and ≤ 50 years
• Broca index ≥ - 20% and ≤ + 20%
• Signed written informed consent in accordance with Good Clinical Practice and local legislation

You may not qualify if:

• Results of the medical examination, laboratory tests or electrocardiogram recordings are judged by the clinical investigator to differ significantly from normal clinical values
• Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Volunteers with diseases of the central nervous system (such as epilepsy), central nervous system trauma in the medical history or with psychiatric disorders or neurological disorders
• Known 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 a drug with a long half-life (≥ 24 hours) within the last month or less than ten half-lives of the respective drug before enrolment in the study
• Intake of any other drugs 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
• Smokers (\> 10 cigarettes or 3 cigars or 3 pipes/day)
• Volunteers who are not able to refrain from smoking on study days
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Participation in excessive physical activities (e.g. competitive sports) within the last week before the study
• Blood donation (≥ 100 ml) within the last 4 weeks

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

BIII 890 CL

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: October 16, 2014
• First Posted: October 20, 2014
• Study Start: April 1, 1999
• Primary Completion: December 1, 1999
• Last Updated: October 20, 2014

Record last verified: 2014-10