Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESR 1150 CL in Healthy Subjects

Boehringer Ingelheim

Status and phase

Terminated

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: ESR 1150 CL

Study type

Interventional

Funder types

Industry

Identifiers

NCT02209688

1172.2

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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