HealthyPhase 1NCT02223507
Single Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Elderly Male and Female Volunteers
A Phase 1 study testing BIIR 561 CL in people with Healthy, run by Boehringer Ingelheim.
Trial 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) Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIIR 561 CL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to Sep 2000
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female volunteers
- Age >= 60 years
- Broca index from -25% to +25%
- Written informed consent prior to admission to the study
Who cannot join
- 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
Show all 16Show fewer
- 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
About this study
Official title: A Single-blind, Placebo-controlled Single Dose Tolerance Study in Healthy Elderly Male and Female Volunteers After Intravenous Administration of BIIR 561 CL as Loading Dose (Dosage: 75 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 40 mg/h and 75 mg/h, Infusion Time 5 Hours)
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)
- Conditions
- Healthy
- Being tested
- BIIR 561 CL, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIR 561 CLDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIIR 561 CL | Experimental | Not described Receives: Drug: BIIR 561 CL |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: 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
Measured: up to 8 days after drug administration
Number of subjects with clinically significant findings in ECG
Measured: up to 8 days after drug administration
Number of subjects with clinically significant findings in laboratory tests
Measured: up to 8 days after drug administration
Secondary outcomes (10)
Maximum drug plasma concentration (Cmax)
Measured: up to 32 hours after first drug administration
Time to Cmax (tmax)
Measured: up to 32 hours after first drug administration
Terminal half-life (t1/2)
Measured: 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)
Measured: up to 32 hours after first drug administration
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)
Measured: up to 32 hours after first drug administration
Mean residence time (MRT)
Measured: up to 32 hours after first drug administration
Plasma clearance (CL)
Measured: up to 32 hours after first drug administration
Volume of distribution (Vz)
Measured: up to 32 hours after first drug administration
Volume of distribution at steady state (Vss)
Measured: up to 32 hours after first drug administration
Amount excreted into urine (Ae)
Measured: up to 32 hours after first drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startAug 2000
- Primary completionSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 13 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223507
- Sponsor's protocol ID
- 600.6
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Placebo-controlled Single Dose Tolerance Study in Healthy Elderly Male and Female Volunteers After Intravenous Administration of BIIR 561 CL as Loading Dose (Dosage: 75 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 40 mg/h and 75 mg/h, Infusion Time 5 Hours)
- ClinicalTrials.gov ID
- NCT02223507
- Acronym / sponsor ID
- 600.6
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- Primary completion
- Sep 2000 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIR 561 CL | Experimental | Drug: BIIR 561 CL |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male and female volunteers
- Age >= 60 years
- Broca index from -25% to +25%
- Written informed consent prior to admission to the study
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIIR 561 CL | Drug | BIIR 561 CL |
| Placebo | Drug | Placebo |
Primary outcome
Number of subjects with adverse events
Time frame: up to 8 days after drug administration
Number of subjects with clinically significant findings in vital functions
Time frame: up to 8 days after drug administration
blood pressure, pulse rate, respiratory rate, oral body temperature
Number of subjects with clinically significant findings in ECG
Time frame: up to 8 days after drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 8 days after drug administration
10 secondary outcomes
Maximum drug plasma concentration (Cmax)
Time frame: up to 32 hours after first drug administration
Time to Cmax (tmax)
Time frame: up to 32 hours after first drug administration
Terminal half-life (t1/2)
Time frame: 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)
Time frame: up to 32 hours after first drug administration
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)
Time frame: up to 32 hours after first drug administration
Mean residence time (MRT)
Time frame: up to 32 hours after first drug administration
Plasma clearance (CL)
Time frame: up to 32 hours after first drug administration
Volume of distribution (Vz)
Time frame: up to 32 hours after first drug administration
Volume of distribution at steady state (Vss)
Time frame: up to 32 hours after first drug administration
Amount excreted into urine (Ae)
Time frame: up to 32 hours after first drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIR 561 CL in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (time frame: up to 8 days after drug administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014.