Status:
TERMINATED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESR 1150 CL in Healthy Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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"
Exclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT02209688
Start Date
February 1 2000
Last Update
August 6 2014
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