HealthyPhase 1NCT02209688
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESR 1150 CL in Healthy Subjects
A Phase 1 study testing ESR 1150 CL in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of this study was to obtain safety and tolerability data and first pharmacokinetic and pharmacodynamic data of escalating doses of ESR 1150 CL. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ESR 1150 CL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Feb 2000to Mar 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female Caucasian subjects as determined by results of screening
- Written informed consent in accordance with Good Clinical Practice and local legislation given
- Age ≥ 18 and ≤ 50 years
- Broca ≥ - 20 % and ≤ + 20 %
- for first part of study: extensive metabolizers of CYP2D6 and/or "spartein" type; for second part of study: poor metabolizers of CYP2D6 and/or "spartein"
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders of neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 20Show 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) (≤ 1 month prior to administration or during the trial, except for oral contraceptives)
- Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial except for oral contraceptives)
- Participation in another trial with an investigational drug (≤ 2 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/days)
- Drug abuse
- Blood donation > 100 ml (≤ 4 weeks prior to administration or during the trial)
- Excessive physical activities (≤ 10 days prior to administration or during the trial)
- Any laboratory value outside the reference range of clinical relevance
- Females only:
- No reliable contraception (examples of reliable contraception: oral contraceptives, 3-month injection, intrauterine device, sterilisation, condoms + spermicide)
- pregnancy or breast feeding period
About this study
Official title: Administration of ESR 1150 CL in Ascending Doses of 0.5, 1, 2, 4 and 8 mg in an Open, Group Comparison and Placebo-controlled Design (Placebo Randomised Double Blind in the Dose Groups) for the Assessment of Safety, Tolerability (Maximum Tolerated Dose, MTD), Pharmacokinetics and Pharmacodynamics in 5 Groups of 8 Female and 5 Male Healthy Subjects, and 4 mg Additionally in Fed State, in a Cross Over Design. Safety, Tolerability and Pharmacokinetics of MTD/4, MTD/2 and MTD in 6 Healthy Male Subjects, Identified as CYP2D6 and/or "Spartein" Poor Metabolizers, in a 3-fold Cross Over, Open Study.
The objective of this study was to obtain safety and tolerability data and first pharmacokinetic and pharmacodynamic data of escalating doses of ESR 1150 CL.
- Conditions
- Healthy
- Being tested
- ESR 1150 CL, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESR 1150 CLDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ESR 1150 CL dose escalation fasted | Experimental | Not described Receives: Drug: ESR 1150 CL |
| ESR 1150 CL fed | Experimental | Not described Receives: Drug: ESR 1150 CL |
| 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 adverse events
Measured: up to 30 days
Area under the curve (AUC)
Measured: up to 24 hours after administration
Maximum concentration (Cmax)
Measured: up to 24 hours after administration
Time to maximum concentration (tmax)
Measured: up to 24 hours after administration
Apparent total plasma clearance (CLtot/f)
Measured: up to 24 hours after administration
Apparent volume of distribution (Vz/f)
Measured: up to 24 hours after administration
Elimination half-life (t1/2)
Measured: up to 24 hours after administration
Amount excreted in urine (Ae)
Measured: up to 24 hours after administration
Maximum flow rate (Qmax)
assessed by free uroflowmetry
Measured: up to 8 hours after administration
Average flow rate (Qave)
assessed by free uroflowmetry
Measured: up to 8 hours after administration
Voided volume (Vcomp)
assessed by free uroflowmetry
Measured: up to 8 hours after administration
Voiding time (T100)
assessed by free uroflowmetry
Measured: up to 8 hours after administration
Time to maximum flow (TQmax)
assessed by free uroflowmetry
Measured: up to 8 hours after administration
Residual urinary volume
assessed by means of transabdominal ultrasound evaluation
Measured: up to 8 hours after administration
Assessment of micturition pattern
evaluated by Independent reviewer
Measured: up to 8 hours after administration
Amount of inhibition constants (Ki) at α1A, adrenoreceptor subtype level
assessed by ex vivo radioreceptor assay
Measured: up to 8 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startFeb 2000
- Primary completionMar 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
- 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
- NCT02209688
- Sponsor's protocol ID
- 1172.2
- Status last verified
- Aug 2014
- First submitted
- 5 Aug 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of ESR 1150 CL in Ascending Doses of 0.5, 1, 2, 4 and 8 mg in an Open, Group Comparison and Placebo-controlled Design (Placebo Randomised Double Blind in the Dose Groups) for the Assessment of Safety, Tolerability (Maximum Tolerated Dose, MTD), Pharmacokinetics and Pharmacodynamics in 5 Groups of 8 Female and 5 Male Healthy Subjects, and 4 mg Additionally in Fed State, in a Cross Over Design. Safety, Tolerability and Pharmacokinetics of MTD/4, MTD/2 and MTD in 6 Healthy Male Subjects, Identified as CYP2D6 and/or "Spartein" Poor Metabolizers, in a 3-fold Cross Over, Open Study.
- ClinicalTrials.gov ID
- NCT02209688
- Acronym / sponsor ID
- 1172.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2000
- Primary completion
- Mar 2000 (actual)
- First posted
- 6 Aug 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 objective of this study was to obtain safety and tolerability data and first pharmacokinetic and pharmacodynamic data of escalating doses of ESR 1150 CL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESR 1150 CL dose escalation fasted | Experimental | Drug: ESR 1150 CL |
| ESR 1150 CL fed | Experimental | Drug: ESR 1150 CL |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female Caucasian subjects as determined by results of screening
- Written informed consent in accordance with Good Clinical Practice and local legislation given
- Age ≥ 18 and ≤ 50 years
- Broca ≥ - 20 % and ≤ + 20 %
- for first part of study: extensive metabolizers of CYP2D6 and/or "spartein" type; for second part of study: poor metabolizers of CYP2D6 and/or "spartein"
Key exclusion criteria (20 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders of 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 |
|---|---|---|
| ESR 1150 CL | Drug | ESR 1150 CL dose escalation fasted, ESR 1150 CL fed |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with adverse events
Time frame: up to 30 days
Area under the curve (AUC)
Time frame: up to 24 hours after administration
Maximum concentration (Cmax)
Time frame: up to 24 hours after administration
Time to maximum concentration (tmax)
Time frame: up to 24 hours after administration
Apparent total plasma clearance (CLtot/f)
Time frame: up to 24 hours after administration
Apparent volume of distribution (Vz/f)
Time frame: up to 24 hours after administration
Elimination half-life (t1/2)
Time frame: up to 24 hours after administration
Amount excreted in urine (Ae)
Time frame: up to 24 hours after administration
Maximum flow rate (Qmax)
Time frame: up to 8 hours after administration
assessed by free uroflowmetry
Average flow rate (Qave)
Time frame: up to 8 hours after administration
assessed by free uroflowmetry
Voided volume (Vcomp)
Time frame: up to 8 hours after administration
assessed by free uroflowmetry
Voiding time (T100)
Time frame: up to 8 hours after administration
assessed by free uroflowmetry
Time to maximum flow (TQmax)
Time frame: up to 8 hours after administration
assessed by free uroflowmetry
Residual urinary volume
Time frame: up to 8 hours after administration
assessed by means of transabdominal ultrasound evaluation
Assessment of micturition pattern
Time frame: up to 8 hours after administration
evaluated by Independent reviewer
Amount of inhibition constants (Ki) at α1A, adrenoreceptor subtype level
Time frame: up to 8 hours after administration
assessed by ex vivo radioreceptor assay
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 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 5 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: stopped early, as of the sponsor's last update on 6 Aug 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 was stopped early. Results are not available in the source record.
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 adverse events (time frame: up to 30 days). The study lists 16 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 6 Aug 2014.