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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 653048 BS H3PO4; Drug: Prednisolone low dose; Drug: Prednisolone high dose; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02217631

1262.2

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 4 patient groups, including a placebo group

BI 653048 BS H3PO4

Experimental group

Description:

dose escalation

Treatment:

Drug: BI 653048 BS H3PO4

Prednisolone low dose

Active Comparator group

Treatment:

Drug: Prednisolone low dose

Prednisolone high dose

Active Comparator group

Treatment:

Drug: Prednisolone high dose

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo