HealthyPhase 1NCT02183259
Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL in Healthy Adult Male Volunteers
A Phase 1 study testing ESR 1150 CL, Capsule, oral and ESR 1150 CL, solution, intravenous in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150 CL. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ESR 1150 CL, Capsule, oral and ESR 1150 CL, solution, intravenous
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Nov 1998to Dec 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male subjects
- age: >= 20 and <= 35 years
- weight: >= 50 to <= 80 kg and within +/- 20 % of standard weight
- blood pressure: systolic 100 - 138 mmHg and diastolic of less than 84 mmHg
- pulse rate: 45 to 80 beat/min
- volunteer whose participation in the trial is judged valid by the investigator based on the results of preliminary check-up and pre-administration check-up
Who cannot join
- history of diseases including cardiac, pulmonary, hepatic, renal or gastrointestinal disease
- history of drug allergy
- history of drug dependency, alcohol dependency, etc.
- use of other trial drug within 6 months before study drug administration
- use of any drugs within 7 days before study drug administration
About this study
Official title: Absolute Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL 1 mg Capsule Compared to 0.015 mg Solution i.v. as Single Administration in Healthy Male Subjects (Open-labelled, 2-way Cross-over Study)
To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150 CL.
- Conditions
- Healthy
- Being tested
- ESR 1150 CL, Capsule, oral, ESR 1150 CL, solution, intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESR 1150 CL, Capsule, oralDrug
ESR 1150 CL, solution, intravenousDrug
| Study group | Role | What they receive |
|---|---|---|
| ESR 1150 CL capsule | Experimental | Not described Receives: Drug: ESR 1150 CL, Capsule, oral |
| ESR 1150 CL ampoule | Experimental | Not described Receives: Drug: ESR 1150 CL, solution, intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma drug concentration-time curve from time zero to infinity
Measured: up to 16 hours after drug administration
maximum drug plasma concentration (Cmax)
Measured: up to 16 hours after drug administration
time to achieve maximum drug plasma concentration (tmax)
Measured: up to 16 hours after drug administration
elimination half-life (t1/2)
Measured: up to 16 hours after drug administration
mean residence time (MRT)
Measured: up to 16 hours after drug administration
total clearance (CL)
Measured: up to 16 hours after drug administration
Secondary outcomes (1)
number of adverse events
Measured: up to day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startNov 1998
- Primary completionDec 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT02183259
- Sponsor's protocol ID
- 1172.1
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absolute Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL 1 mg Capsule Compared to 0.015 mg Solution i.v. as Single Administration in Healthy Male Subjects (Open-labelled, 2-way Cross-over Study)
- ClinicalTrials.gov ID
- NCT02183259
- Acronym / sponsor ID
- 1172.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 1998
- Primary completion
- Dec 1998 (actual)
- First posted
- 8 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.
To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150 CL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESR 1150 CL capsule | Experimental | Drug: ESR 1150 CL, Capsule, oral |
| ESR 1150 CL ampoule | Experimental | Drug: ESR 1150 CL, solution, intravenous |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy male subjects
- age: >= 20 and <= 35 years
- weight: >= 50 to <= 80 kg and within +/- 20 % of standard weight
- blood pressure: systolic 100 - 138 mmHg and diastolic of less than 84 mmHg
- pulse rate: 45 to 80 beat/min
Key exclusion criteria (5 listed)
- history of diseases including cardiac, pulmonary, hepatic, renal or gastrointestinal disease
- history of drug allergy
- history of drug dependency, alcohol dependency, etc.
- use of other trial drug within 6 months before study drug administration
- use of any drugs within 7 days before study drug administration
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 |
|---|---|---|
| ESR 1150 CL, Capsule, oral | Drug | ESR 1150 CL capsule |
| ESR 1150 CL, solution, intravenous | Drug | ESR 1150 CL ampoule |
Primary outcome
Area under the plasma drug concentration-time curve from time zero to infinity
Time frame: up to 16 hours after drug administration
maximum drug plasma concentration (Cmax)
Time frame: up to 16 hours after drug administration
time to achieve maximum drug plasma concentration (tmax)
Time frame: up to 16 hours after drug administration
elimination half-life (t1/2)
Time frame: up to 16 hours after drug administration
mean residence time (MRT)
Time frame: up to 16 hours after drug administration
total clearance (CL)
Time frame: up to 16 hours after drug administration
1 secondary outcome
number of adverse events
Time frame: up to day 22
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 8 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 ESR 1150 CL, Capsule, oral and ESR 1150 CL, solution, intravenous 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 5 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 8 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. 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?
Area under the plasma drug concentration-time curve from time zero to infinity (time frame: up to 16 hours after drug administration). The study lists 6 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 8 Jul 2014.