HealthyPhase 1NCT02264067
Pharmacokinetics and Safety of WAL2014 (Talsaclidine) in Healthy Male Volunteers
A Phase 1 study testing Talsaclidine in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a single dose to healthy adult male volunteers in double blind manner. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Talsaclidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jul 1998to Nov 1998
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects for the study are healthy male adult volunteers who meet all the inclusion criteria listed below and do not fall into the exclusion criteria.
- Age: 20-30 years old
- Body weight: 50-80 kg
- Obesity index: within +/-20% of the standard body weight
- Those who have received screening examinations listed in protocol within one month prior to the start of the clinical study and have been judged as eligible by the investigator. Results of the simple test for gastric acidity are not used as the basis of the judgment.
- Those who belong to volunteer members' association which has an office in Clinical Pharmacology Center, Ohsaki Clinic
Who cannot join
- Those who have a history of allergic reaction or hypersensitivity to drugs
- Those who have received any kind of drug(s) within one month prior to the administration of the investigational product
- Those who have ingested alcoholic drink within two days before the administration of the investigational product
- Those who have been admitted to a hospital, undergone surgery or donated blood within 3 months before the administration of the investigational product
- Those who have participated in a phase I clinical study of a drug which contains a new active ingredient or a similar study within 4 months before the administration of the investigational product
- Those who have a history of liver or renal disease
- Those who are judged as ineligible for the clinical study by the investigator.
About this study
Official title: Phase I Clinical Study of WAL2014 (Talsaclidine) Capsule: A Single Oral Dose Study
To assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a single dose to healthy adult male volunteers in double blind manner.
- Conditions
- Healthy
- Being tested
- Talsaclidine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalsaclidineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Talsaclidine | Experimental | single rising doses Receives: Drug: Talsaclidine |
| 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.
Maximum concentration of the analyte in plasma (Cmax)
Measured: up to 24 hours after drug administration
Time to reach maximum plasma concentration (tmax)
Measured: up to 24 hours after drug administration
Area under the plasma concentration-time curve (AUC)
Measured: up to 24 hours after drug administration
Distribution volume
Measured: up to 24 hours after drug administration
Total clearance
Measured: up to 24 hours after drug administration
Mean residence time (MRT)
Measured: up to 24 hours after drug administration
Urinary excretion rate
Measured: up to 24 hours after drug administration
Number of subjects with adverse events
Measured: up to 8 days after 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 startJul 1998
- Primary completionNov 1998
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
- Double blind
- Enrolment
- 36 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
- NCT02264067
- Sponsor's protocol ID
- 506.111
- 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
- Phase I Clinical Study of WAL2014 (Talsaclidine) Capsule: A Single Oral Dose Study
- ClinicalTrials.gov ID
- NCT02264067
- Acronym / sponsor ID
- 506.111
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 1998
- Primary completion
- Nov 1998 (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 assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a single dose to healthy adult male volunteers in double blind manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Talsaclidine | Experimental | Drug: Talsaclidinesingle rising doses |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects for the study are healthy male adult volunteers who meet all the inclusion criteria listed below and do not fall into the exclusion criteria.
- Age: 20-30 years old
- Body weight: 50-80 kg
- Obesity index: within +/-20% of the standard body weight
- Those who have received screening examinations listed in protocol within one month prior to the start of the clinical study and have been judged as eligible by the investigator. Results of the simple test for gastric acidity are not used as the basis of the judgment.
Key exclusion criteria (7 listed)
- Those who have a history of allergic reaction or hypersensitivity to drugs
- Those who have received any kind of drug(s) within one month prior to the administration of the investigational product
- Those who have ingested alcoholic drink within two days before the administration of the investigational product
- Those who have been admitted to a hospital, undergone surgery or donated blood within 3 months before the administration of the investigational product
- Those who have participated in a phase I clinical study of a drug which contains a new active ingredient or a similar study within 4 months before the administration of the investigational product
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 |
|---|---|---|
| Talsaclidine | Drug | Talsaclidine |
| Placebo | Drug | Placebo |
Primary outcome
Maximum concentration of the analyte in plasma (Cmax)
Time frame: up to 24 hours after drug administration
Time to reach maximum plasma concentration (tmax)
Time frame: up to 24 hours after drug administration
Area under the plasma concentration-time curve (AUC)
Time frame: up to 24 hours after drug administration
Distribution volume
Time frame: up to 24 hours after drug administration
Total clearance
Time frame: up to 24 hours after drug administration
Mean residence time (MRT)
Time frame: up to 24 hours after drug administration
Urinary excretion rate
Time frame: up to 24 hours after drug administration
Number of subjects with adverse events
Time frame: up to 8 days after 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 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 6 inclusion and 7 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. 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?
Maximum concentration of the analyte in plasma (Cmax) (time frame: up to 24 hours after drug administration). The study lists 8 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.