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HealthyPhase 1NCT02171780

A Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses of BI 1744 CL in Healthy Male and Female Volunteers

A Phase 1 study testing BI 1744 CL in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate safety, tolerability, and pharmacokinetics of BI 1744 CL Read more about this study

Who is it for?
Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BI 1744 CL
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
No sites listed yet
Study dates
Feb 2005to Jul 2005
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject is healthy based upon a complete medical history, including the physical examination, regarding vital signs (BP, PR), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease
  • The subject is at least 21 years old and not older than 50 years
  • The subject's body mass index (BMI) is at least 18.5 kg/m2 and less than 30 kg/m2
  • The subject has signed and dated a written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Who cannot join

  • The subject has any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
  • The subject had a surgery of gastrointestinal tract (except appendectomy)
  • The subject has a diagnosis of gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • The subject has a diagnosis of diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • The subject has a history of relevant orthostatic hypotension, fainting spells or blackouts
  • The subject has a diagnosis of chronic or relevant acute infections
Show all 30Show fewer
  • The subject has a history of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
  • The subject has taken drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to randomisation
  • The subject has used drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation
  • The subject has participated in another trial with an investigational drug within two months prior to randomisation
  • The subject is a heavily smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
  • The subject is not able to refrain from smoking on trial days as judged by the investigator
  • The subject uses more than 60 g alcohol a day)
  • The subject uses drugs
  • The subject has donated more than 100 mL blood within four weeks prior to randomisation
  • The subject has performed excessive physical activities within one week prior to randomisation
  • The subject has a laboratory value outside the reference range that is of clinical relevance
  • The subject is not able to comply with dietary regimen of the study centre.
  • The following exclusion criteria were specific for this study due to the known class side effect profile of ß2-mimetics:
  • The subject has a diagnosis of asthma or history of pulmonary hyperreactivity
  • The subject has a diagnosis of hyperthyrosis
  • The subject has a diagnosis of allergic rhinitis in need of treatment
  • The subject has a diagnosis of clinically relevant cardiac arrhythmia
  • The subject has a diagnosis of paroxysmal tachycardia (>100 beats per minute).
  • For female subjects:
  • Pregnancy
  • Positive pregnancy test
  • No adequate contraception e.g. oral contraception, sterilisation, IUD (intrauterine device). Females who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condoms) prior to administration of study medication, during the study and at least one month after release from the study
  • Inability to maintain this adequate contraception during the whole study period
  • Lactation period

About this study

Official title: A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses (0.5 μg to 70 μg Administered With the Respimat®) of BI 1744 CL in Healthy Male and Female Volunteers

To investigate safety, tolerability, and pharmacokinetics of BI 1744 CL

Conditions
Healthy
Being tested
BI 1744 CL, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 1744 CLDrug

  • PlaceboDrug

Study groups in NCT02171780
Study groupRoleWhat they receive
BI 1744 CL single rising dosesExperimentalNot described
Receives: Drug: BI 1744 CL
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with abnormal findings in physical examination

    Measured: 12 days after drug administration

  2. Number of patients with clinically significant changes in vital signs

    Measured: Baseline, up to 12 days after drug administration

  3. Change in orthostasis test parameters

    Measured: Baseline, up to 24 hours after drug administration

  4. Number of patients with abnormal changes in laboratory parameters

    Measured: Baseline, up to 12 days after drug administration

  5. Change in oral body temperature

    Measured: Baseline, up to 24 hours after drug administration

  6. Number of patients with abnormal changes in 12-lead ECG (electrocardiogram) parameters

    Measured: Baseline, up to 12 days after drug administration

  7. Number of patients with adverse events

    Measured: Up to 12 days

  8. Change in tremormetry parameters

    Measured: Baseline, up to 24 hours after drug administration

  9. Number of patients with abnormal findings of oropharyngeal inspection

    Measured: Baseline, up to 24 hours after drug administration

  10. Number of patients with abnormal findings of pulmonary auscultation

    Measured: Baseline, up to 24 hours after drug administration

  11. Change in airway resistance (Raw), as measured by body plethysmography

    Measured: Baseline, up to 24 hours after drug administration

  12. Assessment of tolerability by investigator on a 4-point scale

    Measured: 12 days after drug administration

Secondary outcomes (14)

  1. Area under the concentration-time curve of BI 1744 CL in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)

    Measured: Up to 96 hours after drug administration

  2. Area under the concentration-time curve of BI 1744 CL in plasma over the time interval from 0 to 24 hours (AUC0-24)

    Measured: Up to 96 hours after drug administration

  3. Maximum concentration of BI 1744 CL in plasma (Cmax)

    Measured: Up to 96 hours after drug administration

  4. Time from dosing to maximum concentration (tmax)

    Measured: Up to 96 hours after drug administration

  5. Amount of BI 1744 CLeliminated in urine from the time point t1 to time point t2 (Aet1-t2)

    Measured: Up to 96 hours after drug administration

  6. Fraction of BI 1744 CL eliminated in urine from time point t1 to time point t2 (fet1-t2)

    Measured: Up to 96 hours after drug administration

  7. Renal clearance of BI 1744 CL from 0 to 24 hours (CLR,0-24)

    Measured: Up to 24 hours after drug administration

  8. Terminal rate constant of BI 1744 CL in plasma (λz)

    Measured: Up to 96 hours after drug administration

  9. Terminal half-life of BI 1744 CL in plasma (t½)

    Measured: Up to 96 hours after drug administration

  10. Area under the concentration-time curve of BI 1744 CL in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Measured: Up to 96 hours after drug administration

  11. AUC0-tz over AUC0-∞ (%AUC0-tz)

    Measured: Up to 96 hours after drug administration

  12. Mean residence time of BI 1744 CL in the body after inhalation (MRTih)

    Measured: Up to 96 hours after drug administration

  13. Apparent clearance of BI 1744 CL in the plasma after extravascular administration (CL/F)

    Measured: Up to 96 hours after drug administration

  14. Apparent volume of distribution of BI 1744 CL during the terminal phase λz following an extravascular dose (Vz/F)

    Measured: Up to 96 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.

  1. First posted24 Jun 2014 (estimated)
  2. Study startFeb 2005
  3. Primary completionJul 2005

Resources

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
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02171780
Sponsor's protocol ID
1222.1
Status last verified
Jun 2014
First submitted
20 Jun 2014
Last updated
24 Jun 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 1744 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 30 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 24 Jun 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 abnormal findings in physical examination (time frame: 12 days after drug administration). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02171780.

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 24 Jun 2014.

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