Overview

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 653048 BS H3PO4 Capsule Multiple Rising Doses in Healthy Male Volunteers

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
Summary
The objectives of the trial were to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BI 653048 BS H3PO4 compared with prednisolone.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
Inclusion Criteria:

- Healthy male subjects based on a complete medical history, physical examination, vital
signs (blood pressure and pulse rate), 12-lead ECG, and clinical laboratory tests

- Age of 18 to 50 years

- Body mass index (BMI) of 18.5 to 29.9 kg/m2

- Signed and dated written informed consent in accordance with Good Clinical Practice
and the local legislation

Exclusion Criteria:

- Any clinically relevant deviation from normal in the medical examination including
blood pressure, pulse rate, and ECG

- Any evidence of a clinically relevant concomitant disease

- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological, or hormonal disorders

- Surgery of the gastrointestinal tract (except appendectomy)

- Diseases of the central nervous system (such as epilepsy), psychiatric disorders, or
neurological disorders

- History of relevant orthostatic hypotension, fainting spells, or blackouts

- Chronic or relevant acute infections

- History of relevant allergy or hypersensitivity (including allergy to drug or its
excipients)

- Intake of drugs with a long half-life (>24 h) within at least 1 month or less than 10
half-lives of the respective drug before first treatment with study drug or during
trial

- Use of drugs which might reasonably influence the results of the trial or which
prolong the QT/QTc interval within 10 days before first treatment with study drug or
during trial

- Participation in another trial with an investigational drug within 30 days before
first treatment with study drug or during trial

- Smoker (more than 10 cigarettes, 3 cigars, or 3 pipes per day)

- Inability to refrain from smoking beginning from 1 day before first treatment with
study drug until discharge from the clinical unit

- Alcohol abuse (more than 60 grams per day)

- Drug abuse

- Blood donation of more than 100 mL within 4 weeks before first treatment with study
drug or during trial

- Excessive physical activities within 1 week before first treatment with study drug or
during trial

- Any laboratory value outside the reference range and of clinical relevance

- Inability to comply with dietary regimen of trial site

- A marked baseline prolongation of the QT/QTc interval (e.g. QTc intervals that are
repeatedly longer than 450 ms)

- A history of additional risk factors for torsades de points (e.g. heart failure,
hypokalaemia, or family history of Long QT syndrome