Single Increasing Doses of BIII 890 CL in Healthy Young Male Volunteers and in Healthy Elderly Male and Female Volunteers

NCT02269215 | Completed Phase 1

• 1 other identifier: 599.2
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

Safety, tolerability and pharmacokinetics of BIII 890

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of patients with clinically relevant changes in vital signs

  blood pressure, pulse rate, respiratory rate, body temperature

  Pre-dose, up to 8 days after drug administration

• Number of subjects with clinically relevant changes in 12-lead ECG

  Pre-dose, up to 8 days after drug administration

• Number of subjects with clinically relevant changes in laboratory parameters

  including coagulation parameters

  Pre-dose, up to 8 days after drug administration

• Number of subjects with adverse events

  Up to 8 days after drug administration

Secondary Outcomes (8)

• Maximum measured concentration of the analyte in plasma (Cmax)

  up to 32 hours after start of drug administration

• Time from dosing to the maximum concentration of the analyte in plasma over a uniform dosing interval λz (tmax)

  up to 32 hours after start of drug administration

• Apparent terminal half-life of the analyte in plasma (t1/2)

  up to 32 hours after start of drug administration

• Area under the concentration-time curve of the analyte in plasma (AUC)

  up to 32 hours after start of drug administration

• Mean residence time (MRT)

  up to 32 hours after start of drug administration

Study Arms (2)

BIII 890 CL single rising dose

EXPERIMENTAL

Drug: BIII 890 CL

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIII 890 CL DRUG

BIII 890 CL single rising dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants in the study should be healthy males, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index) and healthy elderly males and females, \> 60 years of age and be within +-25 % of their normal weight (Broca-Index)
• In accordance with good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

You may not qualify if:

• Volunteers were excluded from the study if the results of the medical examination, laboratory tests or ECG recordings are judged by the investigator to differ significantly from normal clinical values
• Volunteers with 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 (CNS) trauma in their medical history or with psychiatric disorders or neurological disorders
• Volunteers with known history of relevant orthostatic hypotension, fainting spells or blackouts
• Volunteers with chronic or relevant acute infections
• Volunteers with history of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as, judged by the investigator
• Volunteers who had taken 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
• Volunteers who received any other drugs which could influence the results of the trial during the week prior to the start of the study
• Volunteers who participated in another study with an investigational drug within the last two months preceding this study
• Volunteers who smoke (\> 10 cigarettes or 3 cigars or 3 pipes/day)
• Volunteers who were not able to refrain from smoking on study days
• Volunteers who drunk more than 60 g of alcohol per day
• Volunteers who were dependent on drugs
• Volunteers who participated in excessive physical activities (e.g. competitive sports) during the last week before the study
• Volunteers who donated blood within the last 4 weeks (≥ 100 mL)

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 20, 2014
• First Posted: October 21, 2014
• Study Start: January 1, 2000
• Primary Completion: September 1, 2000
• Last Updated: October 21, 2014

Record last verified: 2014-10