Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BIRT 2584 XX

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02259894

1206.1

Details and patient eligibility

About

To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in healthy subjects

Enrollment

55 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects as determined by results of screening
Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Age >=18 and <=50 years
BMI >=18.5 and <=29.9 kg/m2

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, immunologic, haematological, oncological or hormonal disorders
Surgery of gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
Relevant 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)
Use of any drugs, which might influence the results of the trial, (< 10 days prior to study drug administration or expected during the trial)
Participation in another trial with an investigational drug (< 2 months prior to administration or expected during trial)
Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
Alcohol abuse (> 60 g/day)
Drug abuse
Blood donation or loss > 400 mL, < 1 month prior to administration or expected during the trial
Clinically relevant laboratory abnormalities
Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval > 110 ms or QT interval, Bazett correction (QTcB) > 450 ms or QT interval >500 ms
Inability to comply with dietary regimen of study centre
Inability to comply with investigator's instructions