Single Dose Followed by Maintenance Dose Tolerance Study... | NCT02223507

Studies
Single Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Elderly Male and Female Volunteers

NCT02223507

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Aug 22, 2014Estimated

Enrollment

Phase

Phase 1

Conditions

Healthy

Interventions

BIIR 561 CL
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2000

Primary Completion Date

Sep 2000Actual

Completion Date

Not provided

First Submitted Date

Aug 21, 2014

First Submission Date that Met QC Criteria

Aug 21, 2014

First Posted Date

Aug 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2014

Last Update Posted Date

Aug 22, 2014Estimated

Description Module

Brief Summary

The objective of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 CL after continuous intravenous administration of two increasing doses in healthy elderly volunteers, following the infusion schema of a loading dose (1 hour) and a maintenance dose (5 hours)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Label	Type	Description	Intervention Names
BIIR 561 CL	Experimental		Drug: BIIR 561 CL
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BIIR 561 CL	Drug		BIIR 561 CL
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Maximum drug plasma concentration (Cmax)		up to 32 hours after first drug administration
Time to Cmax (tmax)		up to 32 hours after first drug administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female volunteers
Age >= 60 years
Broca index from -25% to +25%
Written informed consent prior to admission to the study

Exclusion Criteria:

Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders (exclusion: substitution therapy regarding thyroid gland and/or ovaries)
Diseases of the central nervous system (CNS) (such as epilepsy) or psychiatric disorders or neurological disorders and medical history of such diseases or disorders
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 drugs 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 drugs which might influence the results of the trial (<= one week prior to administration or during the trial)
Participation in another trial with an investigational drug (<= two months prior to administration or during the trial
Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
Inability to refrain from smoking on trial days
Alcohol abuse (> 30g/day for males, > 24 g for females)
Drug abuse
Blood donation (>= 100 ml within four weeks prior to administration or during the trial)
Excessive physical activities (within the last week before the study)
Any laboratory value outside the reference range of clinical relevance

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided