HealthyPhase 1NCT02194283
Study to Evaluate Safety, Tolerability and Pharmacokinetics of Increasing Repeated Oral Doses of Ambroxol Lozenges in Healthy Male Volunteers
A Phase 1 study testing Ambroxol - in single rising doses in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The main objectives of the present study are to determine pharmacokinetics of ambroxol in healthy male volunteers following repeated administration of lozenges of 20 mg ambroxol for four days 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?
- Ambroxol - in single rising doses
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Nov 2009
- 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 according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs, 12-lead Electrocardiogram (ECG), clinical laboratory tests
- Age ≥21 and Age ≤50 year
- BMI ≥18.5 and BMI ≤29.9 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 vital signs and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
Show all 20Show fewer
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of 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 administration or during the trial
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Actual smoker
- Alcohol abuse (more than 40 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
About this study
Official title: A Double-blind (at Each Dose Level), Randomised, Placebo Controlled Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Increasing Repeated Oral Doses of Ambroxol Lozenges (Dosage: 20, 40, 80 mg Three Times Daily) Over 4 Days in Healthy Male Volunteers
The main objectives of the present study are to determine pharmacokinetics of ambroxol in healthy male volunteers following repeated administration of lozenges of 20 mg ambroxol for four days
- Conditions
- Healthy
- Being tested
- Ambroxol - in single rising doses, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambroxol - in single rising dosesDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ambroxol - in single rising doses | Experimental | Not described Receives: Drug: Ambroxol - in single rising doses |
| 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.
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 24 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 24 hours after drug administration
AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)
Measured: up to 24 hours after drug administration
Ae0-24 (amount of the analyte that is eliminated in urine from the time point 0 until time point 24)
Measured: up to 24 hours after drug administration
CLR,0-24 (renal clearance of the analyte determined from the time point 0 until time point 24) using AUC0-24 and Ae0-24
Measured: up to 24 hours after drug administration
Cmax,ss (maximum concentration of the analyte in plasma at steady state)
Measured: up to 120 hours after first drug administration
tmax,ss (time from last dosing to maximum concentration at steady state)
Measured: up to 120 hours after first drug administration
Cmin,ss (minimum concentration of the analyte in plasma at steady state)
Measured: up to 120 hours after first drug administration
AUC72-96,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform 24 hour interval matching Day 1)
Measured: up to 96 hours after first drug administration
Ae72-96,ss (amount of analyte that is eliminated in urine at steady state from the time point 72 to time point 96)
Measured: up to 96 hours after first drug administration
CLR,72-96,ss (renal clearance of the analyte in plasma from the time point 72 until the time point 96 at steady state) using AUC72-96 and Ae72-96
Measured: up to 96 hours after first drug administration
λz,ss (terminal rate constant in plasma at steady state)
Measured: up to 120 hours after first drug administration
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Measured: up to 120 hours after first drug administration
RA (accumulation ratio)
Measured: up to 96 hours after first drug administration
LI (linearity index)
Measured: up to 96 hours after first drug administration
Secondary outcomes (5)
Number of patients with adverse events
Measured: up to 36 days
Number of patients with abnormal changes in laboratory parameters
Measured: up to 36 days
Number of patients with clinically significant changes in vital signs (blood pressure [BP], pulse rate [PR])
Measured: up to 36 days
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Measured: up to 36 days
Assessment of tolerability on a 4-point scale
Measured: 10 days after 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 posted18 Jul 2014 (estimated)
- Study startOct 2009
- Primary completionNov 2009
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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 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
- NCT02194283
- Sponsor's protocol ID
- 18.493
- Status last verified
- Jul 2014
- First submitted
- 17 Jul 2014
- Last updated
- 23 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind (at Each Dose Level), Randomised, Placebo Controlled Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Increasing Repeated Oral Doses of Ambroxol Lozenges (Dosage: 20, 40, 80 mg Three Times Daily) Over 4 Days in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02194283
- Acronym / sponsor ID
- 18.493
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (actual)
- First posted
- 18 Jul 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 main objectives of the present study are to determine pharmacokinetics of ambroxol in healthy male volunteers following repeated administration of lozenges of 20 mg ambroxol for four days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambroxol - in single rising doses | Experimental | Drug: Ambroxol - in single rising doses |
| 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 according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs, 12-lead Electrocardiogram (ECG), clinical laboratory tests
- Age ≥21 and Age ≤50 year
- BMI ≥18.5 and BMI ≤29.9 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 (20 listed)
- Any finding of the medical examination (including vital signs and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
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 |
|---|---|---|
| Ambroxol - in single rising doses | Drug | Ambroxol - in single rising doses |
| Placebo | Drug | Placebo |
Primary outcome
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)
Time frame: up to 24 hours after drug administration
Ae0-24 (amount of the analyte that is eliminated in urine from the time point 0 until time point 24)
Time frame: up to 24 hours after drug administration
CLR,0-24 (renal clearance of the analyte determined from the time point 0 until time point 24) using AUC0-24 and Ae0-24
Time frame: up to 24 hours after drug administration
Cmax,ss (maximum concentration of the analyte in plasma at steady state)
Time frame: up to 120 hours after first drug administration
tmax,ss (time from last dosing to maximum concentration at steady state)
Time frame: up to 120 hours after first drug administration
Cmin,ss (minimum concentration of the analyte in plasma at steady state)
Time frame: up to 120 hours after first drug administration
AUC72-96,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform 24 hour interval matching Day 1)
Time frame: up to 96 hours after first drug administration
Ae72-96,ss (amount of analyte that is eliminated in urine at steady state from the time point 72 to time point 96)
Time frame: up to 96 hours after first drug administration
CLR,72-96,ss (renal clearance of the analyte in plasma from the time point 72 until the time point 96 at steady state) using AUC72-96 and Ae72-96
Time frame: up to 96 hours after first drug administration
λz,ss (terminal rate constant in plasma at steady state)
Time frame: up to 120 hours after first drug administration
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: up to 120 hours after first drug administration
RA (accumulation ratio)
Time frame: up to 96 hours after first drug administration
LI (linearity index)
Time frame: up to 96 hours after first drug administration
5 secondary outcomes
Number of patients with adverse events
Time frame: up to 36 days
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 36 days
Number of patients with clinically significant changes in vital signs (blood pressure [BP], pulse rate [PR])
Time frame: up to 36 days
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Time frame: up to 36 days
Assessment of tolerability on a 4-point scale
Time frame: 10 days after 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 23 Jul 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 Ambroxol - in single rising doses 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 20 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 23 Jul 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?
Cmax (maximum measured concentration of the analyte in plasma) (time frame: up to 24 hours after drug administration). The study lists 15 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 23 Jul 2014.