HealthyPhase 1NCT02264093
Effects on the Airway Lumen of Talsaclidine in Combination With Propranolol in Comparison to the Effects of the Monosubstances in Healthy Elderly Male Volunteers
A Phase 1 study testing Propranolol and Talsaclidine in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate the effects on airway lumen of talsaclidine in combination with propranolol and of talsaclidine and propranolol given as monosubstances Read more about this study
- Who is it for?
- Ages 50 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Propranolol and Talsaclidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Nov 1999to Feb 2000
- 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 50 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants in the study should be healthy males, range from 50 to 65 years of age and be within +- 20% of their normal weight (Broca-Index).
Who cannot join
- Volunteers will be excluded from the study if the result of the medical examination or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical investigator to differ significantly from the normal clinical values
- Volunteers with blood pressure lower than 120/80 mm Hg or pulse rate below 60 beats/min
- Volunteers whose blood pressure dropped below 100/60 mm Hg in the pre-test within 80 mg propranolol
- Volunteers with Raw-values higher than their predicted normal upper limit
- Volunteers with known gastrointestinal, hepatic , renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Volunteers with disease of the central nervous system (such as epilepsy) or with psychiatric disorders
Show all 18Show fewer
- Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
- Volunteers with chronic or relevant acute infections
- Volunteers with history of allergy / hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Volunteers who have taken a drug 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
- Volunteers who received any other drugs which might influence the results of the trial during the week prior the start of the study
- Volunteers who have participated in another study with an investigational drug within the last 2 month preceding this study
- Volunteers who are unable to refrain from smoking on the study days
- Volunteers who smoke more than 10 cigarettes (or 3 cigars or pipes) per day
- Volunteers who drink more than 40 g of alcohol per day
- Volunteers who are dependent on drugs
- Volunteers who have donated blood (>=100ml) within the last 4 weeks
- Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
About this study
Official title: Effects on the Airway Lumen of Single Oral Doses of Talsaclidine (12, 24, 48 and 60 mg) in Combination With a Single Oral Doses of 160 mg Propranolol in Comparison to the Effects of the Monosubstances (60 mg Talsaclidine and 160 mg Propranolol) in Healthy Elderly Male Volunteers (Partially Randomised, Open Label, Intraindividual Comparison)
To investigate the effects on airway lumen of talsaclidine in combination with propranolol and of talsaclidine and propranolol given as monosubstances
- Conditions
- Healthy
- Being tested
- Propranolol, Talsaclidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
TalsaclidineDrug
| Study group | Role | What they receive |
|---|---|---|
| Talsaclidine with Propranol | Experimental | Not described Receives: Drug: Propranolol; Drug: Talsaclidine |
| Propranolol | Active comparator | Not described Receives: Drug: Propranolol |
| Talsaclidine | Active comparator | Not described Receives: Drug: Talsaclidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway resistance (Raw)
Measured: Up to 8 hours after drug administration
Specific conductance (SGaw)
Measured: Up to 8 hours after drug administration
Forced expiratory volume in 1 sec (FEV1)
Measured: Up to 8 hours after drug administration
Secondary outcomes (6)
Number of participants with clinically significant findings in vital signs
Measured: Up to 8 days after last drug administration
Number of participants with clinically significant findings in laboratory tests
Measured: Up to 8 days after last drug administration
Number of participants with adverse events
Measured: Up to 8 days after last drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Measured: Up to 12 hours after drug administration
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Measured: Up to 12 hours after drug administration
AUC (area under the plasma concentration versus time curve)
Measured: Up to 12 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 posted15 Oct 2014 (estimated)
- Study startNov 1999
- Primary completionFeb 2000
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
- 12 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
- NCT02264093
- Sponsor's protocol ID
- 506.114
- Status last verified
- Oct 2014
- First submitted
- 13 Oct 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on the Airway Lumen of Single Oral Doses of Talsaclidine (12, 24, 48 and 60 mg) in Combination With a Single Oral Doses of 160 mg Propranolol in Comparison to the Effects of the Monosubstances (60 mg Talsaclidine and 160 mg Propranolol) in Healthy Elderly Male Volunteers (Partially Randomised, Open Label, Intraindividual Comparison)
- ClinicalTrials.gov ID
- NCT02264093
- Acronym / sponsor ID
- 506.114
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 1999
- Primary completion
- Feb 2000 (actual)
- First posted
- 15 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.
To investigate the effects on airway lumen of talsaclidine in combination with propranolol and of talsaclidine and propranolol given as monosubstances
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Talsaclidine with Propranol | Experimental | Drug: Propranolol, Drug: Talsaclidine |
| Propranolol | Active comparator | Drug: Propranolol |
| Talsaclidine | Active comparator | Drug: Talsaclidine |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants in the study should be healthy males, range from 50 to 65 years of age and be within +- 20% of their normal weight (Broca-Index).
Key exclusion criteria (18 listed)
- Volunteers will be excluded from the study if the result of the medical examination or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical investigator to differ significantly from the normal clinical values
- Volunteers with blood pressure lower than 120/80 mm Hg or pulse rate below 60 beats/min
- Volunteers whose blood pressure dropped below 100/60 mm Hg in the pre-test within 80 mg propranolol
- Volunteers with Raw-values higher than their predicted normal upper limit
- Volunteers with known gastrointestinal, hepatic , renal, respiratory, cardiovascular, metabolic, immunological or hormonal 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 |
|---|---|---|
| Propranolol | Drug | Propranolol, Talsaclidine with Propranol |
| Talsaclidine | Drug | Talsaclidine, Talsaclidine with Propranol |
Primary outcome
Airway resistance (Raw)
Time frame: Up to 8 hours after drug administration
Specific conductance (SGaw)
Time frame: Up to 8 hours after drug administration
Forced expiratory volume in 1 sec (FEV1)
Time frame: Up to 8 hours after drug administration
6 secondary outcomes
Number of participants with clinically significant findings in vital signs
Time frame: Up to 8 days after last drug administration
Number of participants with clinically significant findings in laboratory tests
Time frame: Up to 8 days after last drug administration
Number of participants with adverse events
Time frame: Up to 8 days after last drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to 12 hours after drug administration
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Time frame: Up to 12 hours after drug administration
AUC (area under the plasma concentration versus time curve)
Time frame: Up to 12 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 15 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 Propranolol and Talsaclidine 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 1 inclusion and 18 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 15 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?
Airway resistance (Raw) (time frame: Up to 8 hours after drug administration). The study lists 3 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 15 Oct 2014.