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