HealthyPhase 1NCT02254187
Pharmacokinetics of Salmeterol Via HandiHaler® in Healthy Male Volunteers
A Phase 1 study testing Salmeterol capsule - low, Salmeterol capsule - high and Salmeterol via Serevent® Diskus® in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of this study is to investigate if the systemic drug exposure of at least 25 μg and perhaps 50 μg salmeterol presented as inhalation powder in PE capsules and administered via HandiHaler® 2 does not exceed that of 50 μg Serevent® Diskus® and to investigate safety and tolerability of salmeterol presented… 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?
- Salmeterol capsule - low, Salmeterol capsule - high and Salmeterol via Serevent® Diskus®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Oct 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male based upon a complete medical history, including the physical examination, regarding vital signs ((Blood Pressure (BP), Pulse Rate (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.
- Age ≥21 and ≤50 years
- BMI ≥18.5 and <30 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Who cannot join
- Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
- Evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 24Show fewer
- History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
- Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomization
- Use of 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 randomization
- Participation in another trial with an investigational drug within 2 months prior to randomization
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days as judged by the investigator
- Alcohol abuse (more than 60 g alcohol a day)
- Drug abuse
- Blood donation (more than 100 mL blood within 4 weeks prior to randomization or during the trial)
- Excessive physical activities within 1 week prior to randomization or during the trial
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of the study centre
- The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:
- Asthma or history of pulmonary hyperreactivity
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Clinically relevant cardiac arrhythmia
- Paroxysmal tachycardia (>100 beats per minute)
About this study
Official title: A Randomised, Open-label Three-way Crossover Study to Evaluate the Pharmacokinetics of Salmeterol After Inhalation of a 25 μg and 50 μg Single Dose (Inhalation Powder, Hard PE Capsule for HandiHaler®2) and a 50 μg Single Dose (Serevent® Diskus®) in Healthy Male Volunteers
The objective of this study is to investigate if the systemic drug exposure of at least 25 μg and perhaps 50 μg salmeterol presented as inhalation powder in PE capsules and administered via HandiHaler® 2 does not exceed that of 50 μg Serevent® Diskus® and to investigate safety and tolerability of salmeterol presented as inhalation powder in PE capsules and administered via HandiHaler® 2
- Conditions
- Healthy
- Being tested
- Salmeterol capsule - low, Salmeterol capsule - high, Salmeterol via Serevent® Diskus®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmeterol capsule - lowDrug
Salmeterol capsule - highDrug
Salmeterol via Serevent® Diskus®Drug
| Study group | Role | What they receive |
|---|---|---|
| Salmeterol capsule via Handihaler - low | Experimental | Not described Receives: Drug: Salmeterol capsule - low |
| Salmeterol capsule via Handihaler - high | Experimental | Not described Receives: Drug: Salmeterol capsule - high |
| Salmeterol via Serevent® Diskus® | Active comparator | Not described Receives: Drug: Salmeterol via Serevent® Diskus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ (area under the concentration-time curve of salmeterol in blood plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 8 hours after drug administration
Cmax (maximum measured concentration of salmeterol in blood plasma)
Measured: up to 8 hours after drug administration
Secondary outcomes (13)
AUC0-tz (area under the concentration-time curve of salmeterol in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 8 hours after drug administration
AUCt1-t2 (area under the concentration time curve of salmeterol in plasma over the time interval t1 to t2)
Measured: up to 8 hours after drug administration
tmax (time from dosing to the maximum concentration of salmeterol in plasma)
Measured: up to 8 hours after drug administration
λz (terminal rate constant in plasma)
Measured: up to 8 hours after drug administration
t½ (terminal half-life of salmeterol in plasma)
Measured: up to 8 hours after drug administration
MRTih (mean residence time of salmeterol in the body after inhalational administration)
Measured: up to 8 hours after drug administration
CL/F (apparent clearance of salmeterol in the plasma after extravascular administration)
Measured: up to 8 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase (λz) following an extravascular dose)
Measured: up to 8 hours after drug administration
Number of patients with abnormal changes in laboratory parameters
Measured: up to 14 days following the last drug administration
Number of patients with clinically significant changes in vital signs
Blood Pressure, Pulse Rate
Measured: up to 14 days following the last drug administration
Number of patients with clinically significant changes in 12-lead ECG parameters
Measured: up to 14 days following the last drug administration
Number of patients with adverse events
Measured: up to 14 days following the last drug administration
Assessment of tolerability by investigator on a 4-point scale
Measured: 14 days following the last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startSep 2005
- Primary completionOct 2005
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT02254187
- Sponsor's protocol ID
- 1184.17
- Status last verified
- Sep 2014
- First submitted
- 29 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label Three-way Crossover Study to Evaluate the Pharmacokinetics of Salmeterol After Inhalation of a 25 μg and 50 μg Single Dose (Inhalation Powder, Hard PE Capsule for HandiHaler®2) and a 50 μg Single Dose (Serevent® Diskus®) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02254187
- Acronym / sponsor ID
- 1184.17
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Oct 2005 (actual)
- First posted
- 1 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.
The objective of this study is to investigate if the systemic drug exposure of at least 25 μg and perhaps 50 μg salmeterol presented as inhalation powder in PE capsules and administered via HandiHaler® 2 does not exceed that of 50 μg Serevent® Diskus® and to investigate safety and tolerability of salmeterol presented as inhalation powder in PE capsules and administered via HandiHaler® 2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Salmeterol capsule via Handihaler - low | Experimental | Drug: Salmeterol capsule - low |
| Salmeterol capsule via Handihaler - high | Experimental | Drug: Salmeterol capsule - high |
| Salmeterol via Serevent® Diskus® | Active comparator | Drug: Salmeterol via Serevent® Diskus® |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male based upon a complete medical history, including the physical examination, regarding vital signs ((Blood Pressure (BP), Pulse Rate (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.
- Age ≥21 and ≤50 years
- BMI ≥18.5 and <30 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Key exclusion criteria (24 listed)
- Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
- Evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
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 |
|---|---|---|
| Salmeterol capsule - low | Drug | Salmeterol capsule via Handihaler - low |
| Salmeterol capsule - high | Drug | Salmeterol capsule via Handihaler - high |
| Salmeterol via Serevent® Diskus® | Drug | Salmeterol via Serevent® Diskus® |
Primary outcome
AUC0-∞ (area under the concentration-time curve of salmeterol in blood plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 8 hours after drug administration
Cmax (maximum measured concentration of salmeterol in blood plasma)
Time frame: up to 8 hours after drug administration
13 secondary outcomes
AUC0-tz (area under the concentration-time curve of salmeterol in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 8 hours after drug administration
AUCt1-t2 (area under the concentration time curve of salmeterol in plasma over the time interval t1 to t2)
Time frame: up to 8 hours after drug administration
tmax (time from dosing to the maximum concentration of salmeterol in plasma)
Time frame: up to 8 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 8 hours after drug administration
t½ (terminal half-life of salmeterol in plasma)
Time frame: up to 8 hours after drug administration
MRTih (mean residence time of salmeterol in the body after inhalational administration)
Time frame: up to 8 hours after drug administration
CL/F (apparent clearance of salmeterol in the plasma after extravascular administration)
Time frame: up to 8 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase (λz) following an extravascular dose)
Time frame: up to 8 hours after drug administration
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 14 days following the last drug administration
Number of patients with clinically significant changes in vital signs
Time frame: up to 14 days following the last drug administration
Number of patients with clinically significant changes in 12-lead ECG parameters
Time frame: up to 14 days following the last drug administration
Number of patients with adverse events
Time frame: up to 14 days following the last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: 14 days following the last 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 1 Oct 2014.
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.
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 Salmeterol capsule - low, Salmeterol capsule - high and Salmeterol via Serevent® Diskus® 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 24 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 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. 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?
AUC0-∞ (area under the concentration-time curve of salmeterol in blood plasma over the time interval from 0 extrapolated to infinity) (time frame: up to 8 hours after drug administration). The study lists 2 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 1 Oct 2014.