HealthyPhase 1NCT01651598
Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients
A Phase 1 study testing BI 144807 in people with Healthy and Asthma, run by Boehringer Ingelheim at 1 site in United Kingdom.
Trial summary
In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of multiple dose administration of BI 144807 will be investigated in otherwise healthy, controlled asthmatic patients Read more about this study
- Who is it for?
- Ages 18 to 55 years
- What is being tested?
- BI 144807
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2012to Jan 2013
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. mild asthmatic, otherwise healthy subjects (male and female of non-childbearing potential)
Who cannot join
- 1. Apart from mild asthma any relevant deviation from healthy conditions
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
1313.2.44001 Boehringer Ingelheim Investigational Site
Manchester
About this study
Official title: Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Multiple Rising Doses of BI 144807 Powder for Oral Drinking Solution Over a Period of 14 Days in Otherwise Healthy Controlled Asthmatic Subjects in a Randomised, Double-blind, Placebo-controlled Trial
In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of multiple dose administration of BI 144807 will be investigated in otherwise healthy, controlled asthmatic patients
- Being tested
- Placebo to BI 144807, BI 144807
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo to BI 144807Drug
multiple dose (bid)
BI 144807Drug
multiple dose (bid, low to high dose)
| Study group | Role | What they receive |
|---|---|---|
| BI 144807 | Experimental | Subjects receive multiple BID doses of BI 144807 solution Receives: Drug: BI 144807 |
| Placebo | Placebo comparator | Subjects receive multiple BID doses of Placebo solution Receives: Drug: Placebo to BI 144807 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (% patients) of drug-related adverse events
Measured: up to 28 days
Secondary outcomes (10)
Maximum measured concentration of the analyte in plasma after first dose (Cmax)
Measured: up to 24 hours after first dose
Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss)
Measured: up to 72 hours after last dose
Time from first dosing to maximum measured concentration (Tmax)
Measured: up to 24 hours after first dose
Time from last dosing to maximum measured concentration (Tmax,ss)
Measured: up to 72 hours after last dose
Area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2 after administration of the first dose (AUCt1-t2)
Measured: up to 24 hours after first dose
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss)
Measured: up to 72 hours after last dose
Terminal half-life of the analyte in plasma after the first dose (t1/2)
Measured: up to 24 hours after first dose
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Measured: up to 72 hours after last dose
RA,Cmax (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose)
Measured: up to 72 hours after last dose
RA,AUC (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of AUC at steady state and after single dose)
Measured: up to 72 hours after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2013
- Study completionJan 2013
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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651598
- Sponsor's protocol ID
- 1313.2
- Other IDs
- 2012-001615-23
- Status last verified
- Oct 2013
- First submitted
- 23 Jul 2012
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Multiple Rising Doses of BI 144807 Powder for Oral Drinking Solution Over a Period of 14 Days in Otherwise Healthy Controlled Asthmatic Subjects in a Randomised, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01651598
- Acronym / sponsor ID
- 1313.2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 27 Jul 2012 (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.
In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of multiple dose administration of BI 144807 will be investigated in otherwise healthy, controlled asthmatic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 144807 | Experimental | Drug: BI 144807Subjects receive multiple BID doses of BI 144807 solution |
| Placebo | Placebo comparator | Drug: Placebo to BI 144807Subjects receive multiple BID doses of Placebo solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. mild asthmatic, otherwise healthy subjects (male and female of non-childbearing potential)
Key exclusion criteria (1 listed)
- 1. Apart from mild asthma any relevant deviation from healthy conditions
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 |
|---|---|---|
| Placebo to BI 144807multiple dose (bid) | Drug | Placebo |
| BI 144807multiple dose (bid, low to high dose) | Drug | BI 144807 |
Primary outcome
Number (% patients) of drug-related adverse events
Time frame: up to 28 days
10 secondary outcomes
Maximum measured concentration of the analyte in plasma after first dose (Cmax)
Time frame: up to 24 hours after first dose
Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss)
Time frame: up to 72 hours after last dose
Time from first dosing to maximum measured concentration (Tmax)
Time frame: up to 24 hours after first dose
Time from last dosing to maximum measured concentration (Tmax,ss)
Time frame: up to 72 hours after last dose
Area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2 after administration of the first dose (AUCt1-t2)
Time frame: up to 24 hours after first dose
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss)
Time frame: up to 72 hours after last dose
Terminal half-life of the analyte in plasma after the first dose (t1/2)
Time frame: up to 24 hours after first dose
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Time frame: up to 72 hours after last dose
RA,Cmax (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose)
Time frame: up to 72 hours after last dose
RA,AUC (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of AUC at steady state and after single dose)
Time frame: up to 72 hours after last dose
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 1 Nov 2013.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 144807 in people with Healthy and Asthma, run by Boehringer Ingelheim at 1 site in United Kingdom.
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 1 inclusion and 1 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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 (% patients) of drug-related adverse events (time frame: up to 28 days). 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 1 Nov 2013.