Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Biomarkers) of BI 653048 BS H3PO4 Capsule Formulation Administered as Multiple Doses of 25 mg to 200 mg qd for 10 Days. A Randomised, Double-blind Within Dose Groups, Placebo-controlled, Multiple Rising Dose Trial With Open-label Active Comparator

NCT02217631 Phase 1 COMPLETED

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.

Details

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	COMPLETED
Enrolment	140
Start date	2009-10

Conditions

• Healthy

Interventions

• BI 653048 BS H3PO4
• Prednisolone low dose
• Prednisolone high dose
• Placebo

Primary outcomes

• Number of patients with adverse events — up to day 14
• Number of patients with clinically significant findings in vital signs — up to 10 days after last drug administration
  blood pressure, pulse rate, body temperature, orthostatic test
• Number of patients with clinically significant findings in ECG — up to 10 days after last drug administration
• Number of patients with clinically significant findings in laboratory tests — up to 10 days after last drug administration
• Assessment of tolerability by the investigator on a four-point scale — up to 10 days after last drug administration