HealthyPhase 1NCT02260037
Dose Tolerance Study in Healthy Male Volunteers After Intranasal Application of Epinastine Nasal
A Phase 1 study testing Epinastine nasal in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Safety, tolerability and pharmacokinetics 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?
- Epinastine nasal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Aug 2001to Sep 2001
- 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
- All participants in the study should be healthy, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca -Index)
- Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG. Haematological, hepatic and renal function tests will be carried out in the laboratory (Bioscientia Ingelheim, Germany). The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
- In accordance with good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 17Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
- Use of any drugs which might influence the results of the trial (≤ one week prior to administration or during the trial)
- Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within the last week before the study)
- Any laboratory value outside the reference range of clinical relevance
About this study
Official title: A Double-blind, Randomised, Placebo-controlled Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intranasal Application of Epinastine Nasal (Dosage: 0.035 mg (0.025 % Solution) - 0.42 mg (0.3 % Solution))
Safety, tolerability and pharmacokinetics
- Conditions
- Healthy
- Being tested
- Epinastine nasal, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinastine nasalDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Epinastine nasal | Experimental | single rising doses Receives: Drug: Epinastine nasal |
| 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 findings in vital signs
blood pressure, pulse rate
Measured: up to 8 days after drug administration
Number of patients with clinically relevant findings in 12-lead ECG
Measured: up to 8 days after drug administration
Number of patients with adverse events
Measured: up to 8 days after drug administration
Number of patients with clinically relevant findings in laboratory parameters
Measured: up to 8 days after drug administration
Changes in rhinoscopy assessment
Measured: up to 8 days after drug administration
Secondary outcomes (11)
Maximum measured concentration in plasma (Cmax)
Measured: up to 48 hours after drug administration
Time from dosing to the maximum concentration in plasma (tmax)
Measured: up to 48 hours drug administration
Area under the concentration-time curve in plasma (AUC)
Measured: up to 48 hours after drug administration
Terminal rate constant of in plasma (λz)
Measured: up to 48 hours after drug administration
Apparent terminal half-life in plasma (t1/2)
Measured: up to 48 hours after drug administration
Total mean residence time in the body (MRTtot)
Measured: up to 48 hours after drug administration
Total clearance in plasma after extravascular administration (CL/F)
Measured: up to 48 hours after drug administration
Apparent volume of distribution during the terminal phase (Vz/F)
Measured: up to 48 hours after drug administration
Amount excreted into urine (Ae)
Measured: up to 48 hours after drug administration
Renal clearance (CLR)
Measured: up to 48 hours after drug administration
Assessment of dose-proportionality of epinastine nasal
based on AUC and Cmax
Measured: up to 48 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 posted9 Oct 2014 (estimated)
- Study startAug 2001
- Primary completionSep 2001
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
- None (open label)
- Enrolment
- 39 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
- NCT02260037
- Sponsor's protocol ID
- 262.261
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intranasal Application of Epinastine Nasal (Dosage: 0.035 mg (0.025 % Solution) - 0.42 mg (0.3 % Solution))
- ClinicalTrials.gov ID
- NCT02260037
- Acronym / sponsor ID
- 262.261
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Sep 2001 (actual)
- First posted
- 9 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.
Safety, tolerability and pharmacokinetics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinastine nasal | Experimental | Drug: Epinastine nasalsingle 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 (3 listed)
- All participants in the study should be healthy, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca -Index)
- Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG. Haematological, hepatic and renal function tests will be carried out in the laboratory (Bioscientia Ingelheim, Germany). The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
- In accordance with good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Key exclusion criteria (17 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of 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 |
|---|---|---|
| Epinastine nasal | Drug | Epinastine nasal |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with clinically relevant findings in vital signs
Time frame: up to 8 days after drug administration
blood pressure, pulse rate
Number of patients with clinically relevant findings in 12-lead ECG
Time frame: up to 8 days after drug administration
Number of patients with adverse events
Time frame: up to 8 days after drug administration
Number of patients with clinically relevant findings in laboratory parameters
Time frame: up to 8 days after drug administration
Changes in rhinoscopy assessment
Time frame: up to 8 days after drug administration
11 secondary outcomes
Maximum measured concentration in plasma (Cmax)
Time frame: up to 48 hours after drug administration
Time from dosing to the maximum concentration in plasma (tmax)
Time frame: up to 48 hours drug administration
Area under the concentration-time curve in plasma (AUC)
Time frame: up to 48 hours after drug administration
Terminal rate constant of in plasma (λz)
Time frame: up to 48 hours after drug administration
Apparent terminal half-life in plasma (t1/2)
Time frame: up to 48 hours after drug administration
Total mean residence time in the body (MRTtot)
Time frame: up to 48 hours after drug administration
Total clearance in plasma after extravascular administration (CL/F)
Time frame: up to 48 hours after drug administration
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: up to 48 hours after drug administration
Amount excreted into urine (Ae)
Time frame: up to 48 hours after drug administration
Renal clearance (CLR)
Time frame: up to 48 hours after drug administration
Assessment of dose-proportionality of epinastine nasal
Time frame: up to 48 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 9 Oct 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 Epinastine nasal 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 3 inclusion and 17 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 9 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. 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 findings in vital signs (time frame: up to 8 days after drug administration). The study lists 5 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 9 Oct 2014.