HealthyPhase 1NCT02209714
Safety, Tolerability and Pharmacodynamics After Oral Administration of BIIF 1149 BS in Healthy Male Volunteers
A Phase 1 study testing BIIF 1149 BS in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of the study is to obtain information about the safety and tolerability of BIIF 1149 BS45 (single dose: 40, 65, 100 mg), to determine the pharmacologically active dose (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic data. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIIF 1149 BS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Nov 1999to Feb 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males, based on a complete medical examination
- Age range from 21 to 50 years
- +/- 20 % of their normal weight (Broca-Index)
- Written informed consent
Who cannot join
- Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical 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) or with psychiatric disorders
- Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
- Volunteers with chronic or relevant acute infections (especially respiratory infections, cough)
- Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 15Show fewer
- Volunteers who have taken a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study
- Volunteers who received any other drugs which might influence the results of the study during the week prior to the start of the study
- Volunteers who have participated in another study with an investigational drug within the last 2 months preceding this study
- Volunteers who smoke more than 10 cigarettes (or equivalent) per day
- Volunteers who are not able to refrain from smoking on study days
- Volunteers who drink more than 40 g of alcohol per day
- Volunteers who are dependent on drugs
- Volunteers who are participated in excessive physical activities (e.g. competitive sports) during the last week before the study
- Volunteers who have donated blood (≥ 100 ml) within the last four weeks
About this study
Official title: A Single Increasing Dose Safety, Tolerability and Pharmacodynamics (Citric Acid Challenge) Study After Oral Administration of BIIF 1149 BS (Single Doses as Tablets: 40, 65, 100 mg) in Healthy Male Volunteers (Randomised, Double-blind Within Each Dose Group, Placebo-controlled, Parallel Groups)
The objective of the study is to obtain information about the safety and tolerability of BIIF 1149 BS45 (single dose: 40, 65, 100 mg), to determine the pharmacologically active dose (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic data.
- Conditions
- Healthy
- Being tested
- BIIF 1149 BS, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIF 1149 BSDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIIF 1149 BS | Experimental | Not described Receives: Drug: BIIF 1149 BS |
| 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 functions (blood pressure, pulse rate)
Measured: up to 8 days after last drug administration
Number of patients with clinically relevant changes in electrocardiogram (ECG)
Measured: up to 8 days after last drug administration
Number of patients with clinically relevant changes in laboratory parameters
Measured: up to 8 days after last drug administration
Number of patients with adverse events
Measured: up to 8 days after last drug administration
Secondary outcomes (10)
Maximum drug plasma concentration (Cmax)
Measured: up to 360 hours after drug administration
Time to reach maximum drug concentration (tmax)
Measured: up to 360 hours after drug administration
Total area under the plasma drug concentration-time curve (AUC) for several time points
Measured: up to 360 hours after drug administration
Terminal half-life (t1/2)
Measured: up to 360 hours after drug administration
Mean residence time (MRT)
Measured: up to 360 hours after drug administration
Total clearance after oral administration (CLtot/f)
Measured: up to 360 hours after drug administration
Amount of drug excreted in urine (Ae)
Measured: up to 360 hours after drug administration
Measurement of pharmacodynamic activity
Citric acid challenge
Measured: Screening, at least 15 days after first administration
Volume of Distribution during terminal phase after oral administration (Vz/F)
Measured: up to 360 hours after drug administration
Renal clearance in the time interval form 0 to x h (Clren0-xh)
Measured: up to 360 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startNov 1999
- Primary completionFeb 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
- Double blind
- Enrolment
- 24 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
- NCT02209714
- Sponsor's protocol ID
- 1157.4
- Status last verified
- Aug 2014
- First submitted
- 5 Aug 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Increasing Dose Safety, Tolerability and Pharmacodynamics (Citric Acid Challenge) Study After Oral Administration of BIIF 1149 BS (Single Doses as Tablets: 40, 65, 100 mg) in Healthy Male Volunteers (Randomised, Double-blind Within Each Dose Group, Placebo-controlled, Parallel Groups)
- ClinicalTrials.gov ID
- NCT02209714
- Acronym / sponsor ID
- 1157.4
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 1999
- Primary completion
- Feb 2000 (actual)
- First posted
- 6 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 study is to obtain information about the safety and tolerability of BIIF 1149 BS45 (single dose: 40, 65, 100 mg), to determine the pharmacologically active dose (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIF 1149 BS | Experimental | Drug: BIIF 1149 BS |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males, based on a complete medical examination
- Age range from 21 to 50 years
- +/- 20 % of their normal weight (Broca-Index)
- Written informed consent
Key exclusion criteria (15 listed)
- Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical 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) or with psychiatric disorders
- Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
- Volunteers with chronic or relevant acute infections (especially respiratory infections, cough)
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 |
|---|---|---|
| BIIF 1149 BS | Drug | BIIF 1149 BS |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with clinically relevant changes in vital functions (blood pressure, pulse rate)
Time frame: up to 8 days after last drug administration
Number of patients with clinically relevant changes in electrocardiogram (ECG)
Time frame: up to 8 days after last drug administration
Number of patients with clinically relevant changes in laboratory parameters
Time frame: up to 8 days after last drug administration
Number of patients with adverse events
Time frame: up to 8 days after last drug administration
10 secondary outcomes
Maximum drug plasma concentration (Cmax)
Time frame: up to 360 hours after drug administration
Time to reach maximum drug concentration (tmax)
Time frame: up to 360 hours after drug administration
Total area under the plasma drug concentration-time curve (AUC) for several time points
Time frame: up to 360 hours after drug administration
Terminal half-life (t1/2)
Time frame: up to 360 hours after drug administration
Mean residence time (MRT)
Time frame: up to 360 hours after drug administration
Total clearance after oral administration (CLtot/f)
Time frame: up to 360 hours after drug administration
Amount of drug excreted in urine (Ae)
Time frame: up to 360 hours after drug administration
Measurement of pharmacodynamic activity
Time frame: Screening, at least 15 days after first administration
Volume of Distribution during terminal phase after oral administration (Vz/F)
Time frame: up to 360 hours after drug administration
Renal clearance in the time interval form 0 to x h (Clren0-xh)
Time frame: up to 360 hours after 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 6 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 BIIF 1149 BS 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 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 6 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 patients with clinically relevant changes in vital functions (blood pressure, pulse rate) (time frame: up to 8 days after last 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 6 Aug 2014.