drugset
drugset / Trial / NCT02254096

Safety, Pharmacokinetics and Pharmacodynamics of BIRT 1696 BS in Healthy Human Subjects

NCT02254096 ↗

Phase 1 Completed 46 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

The objectives are: 1. To assess safety, pharmacokinetics, and pharmacodynamics of BIRT 1696 BS in rising single doses. 2. To assess safety, pharmacokinetics, and pharmacodynamics of single dose of 100 mg BIRT 1696 BS after grapefruit juice. 3. To asses safety and pharmacokinetics of single dose of 400 mg BIRT 1696 BS after a 67 g fat and high caloric breakfast.

Timeline

Start
2002-05
Primary completion
2002-07
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject BIRT 1696 BS Unknown 10 mg Oral
Subject BIRT 1696 BS Unknown 100 mg Oral
Subject BIRT 1696 BS Unknown 400 mg Oral
Subject BIRT 1696 BS Unknown 1000 mg Oral
Subject BIRT 1696 BS Unknown 2000 mg Oral
Subject BIRT 1696 BS Unknown 3000 mg Oral

Indications

No indication recorded.