drugset / Trial / NCT01386541

Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers

NCT01386541 ↗

Phase 1 Completed 36 enrolled Nycomed
RandomizedCrossoverDouble-blindTreatment

Summary

This monocenter trial is conducted to obtain first data on safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677 in humans. In addition, the trial should provide preliminary information on a possible influence of sex, food intake, and posology (once or twice daily administration of BYK324677) to support the further planning of the drug development programme.

Timeline

Start
2011-06
Primary completion
2011-09
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator BYK324677 Unknown 1 mg Oral
Comparator BYK324677 Unknown 2 mg Oral
Comparator BYK324677 Unknown 3 mg Oral
Comparator BYK324677 Unknown 4 mg Oral
Comparator BYK324677 Unknown 6 mg Oral