HealthyPhase 1NCT02269215
Single Increasing Doses of BIII 890 CL in Healthy Young Male Volunteers and in Healthy Elderly Male and Female Volunteers
A Phase 1 study testing BIII 890 CL in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Safety, tolerability and pharmacokinetics of BIII 890 Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIII 890 CL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Jan 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
About this study
Official title: A Single Blind, Placebo-controlled, Parallel-group, Single Increasing Dose Tolerance Study in Healthy Young Male Volunteers After Intravenous Administration of BIII 890 CL as Loading Dose (Dosage: 12.5, 25, 50 mg/h, Infusion Time 1 hr; 50 mg/h, Infusion Time 2 Hrs) Followed by Maintenance Dose (Dosage: 6.25, 12.5, 25 mg/h, Infusion Time 5 Hrs; 30 mg/h, Infusion Time 4 Hrs) and in Healthy Elderly Male and Female Volunteers After Intravenous Administration of BIII 890 CL as Loading Dose (Dosage: 50 mg/h, Infusion Time 1 hr) Followed by Maintenance Dose (Dosage: 25 mg/h, Infusion Time 5 Hrs)
Safety, tolerability and pharmacokinetics of BIII 890
- Conditions
- Healthy
- Being tested
- BIII 890 CL, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIII 890 CLDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIII 890 CL single rising dose | Experimental | Not described Receives: Drug: BIII 890 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 patients with clinically relevant changes in vital signs
blood pressure, pulse rate, respiratory rate, body temperature
Measured: Pre-dose, up to 8 days after drug administration
Number of subjects with clinically relevant changes in 12-lead ECG
Measured: Pre-dose, up to 8 days after drug administration
Number of subjects with clinically relevant changes in laboratory parameters
including coagulation parameters
Measured: Pre-dose, up to 8 days after drug administration
Number of subjects with adverse events
Measured: Up to 8 days after drug administration
Secondary outcomes (8)
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: 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)
Measured: up to 32 hours after start of drug administration
Apparent terminal half-life of the analyte in plasma (t1/2)
Measured: up to 32 hours after start of drug administration
Area under the concentration-time curve of the analyte in plasma (AUC)
Measured: up to 32 hours after start of drug administration
Mean residence time (MRT)
Measured: up to 32 hours after start of drug administration
Plasma clearance (CL)
Measured: up to 32 hours after start of drug administration
Volume of distribution (V)
Measured: up to 32 hours after start of drug administration
Amount of parent drug excreted into urine (Ae)
Measured: up to 32 hours after start of drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startJan 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269215
- Sponsor's protocol ID
- 599.2
- Status last verified
- Oct 2014
- First submitted
- 20 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Placebo-controlled, Parallel-group, Single Increasing Dose Tolerance Study in Healthy Young Male Volunteers After Intravenous Administration of BIII 890 CL as Loading Dose (Dosage: 12.5, 25, 50 mg/h, Infusion Time 1 hr; 50 mg/h, Infusion Time 2 Hrs) Followed by Maintenance Dose (Dosage: 6.25, 12.5, 25 mg/h, Infusion Time 5 Hrs; 30 mg/h, Infusion Time 4 Hrs) and in Healthy Elderly Male and Female Volunteers After Intravenous Administration of BIII 890 CL as Loading Dose (Dosage: 50 mg/h, Infusion Time 1 hr) Followed by Maintenance Dose (Dosage: 25 mg/h, Infusion Time 5 Hrs)
- ClinicalTrials.gov ID
- NCT02269215
- Acronym / sponsor ID
- 599.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Primary completion
- Sep 2000 (actual)
- First posted
- 21 Oct 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.
Safety, tolerability and pharmacokinetics of BIII 890
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIII 890 CL single rising dose | Experimental | Drug: BIII 890 CL |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| BIII 890 CL | Drug | BIII 890 CL single rising dose |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with clinically relevant changes in vital signs
Time frame: Pre-dose, up to 8 days after drug administration
blood pressure, pulse rate, respiratory rate, body temperature
Number of subjects with clinically relevant changes in 12-lead ECG
Time frame: Pre-dose, up to 8 days after drug administration
Number of subjects with clinically relevant changes in laboratory parameters
Time frame: Pre-dose, up to 8 days after drug administration
including coagulation parameters
Number of subjects with adverse events
Time frame: Up to 8 days after drug administration
8 secondary outcomes
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: 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)
Time frame: up to 32 hours after start of drug administration
Apparent terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 32 hours after start of drug administration
Area under the concentration-time curve of the analyte in plasma (AUC)
Time frame: up to 32 hours after start of drug administration
Mean residence time (MRT)
Time frame: up to 32 hours after start of drug administration
Plasma clearance (CL)
Time frame: up to 32 hours after start of drug administration
Volume of distribution (V)
Time frame: up to 32 hours after start of drug administration
Amount of parent drug excreted into urine (Ae)
Time frame: up to 32 hours after start of 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 21 Oct 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 BIII 890 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 2 inclusion and 15 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 21 Oct 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 patients with clinically relevant changes in vital signs (time frame: Pre-dose, 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 21 Oct 2014.