drugset / Trial / NCT02194335

Safety, Tolerability and Pharmacokinetics of Increasing Doses of BIBN 4096 BS in Healthy Male and Female Volunteers

NCT02194335 ↗

Phase 1 Completed 32 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of the present study was to obtain information about safety, tolerability and pharmacokinetics of BIBN 4096 BS after oral administration of increasing doses in healthy male and female volunteers. With respect to pharmacokinetics, it was of particular importance to investigate whether therapeutic plasma levels (for treatment of migraine) could have been achieved by oral administration of a BIBN 4096 BS formulation.

Timeline

Start
2000-10
Primary completion
2000-12
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject OLCEGEPANT Small molecule — Oral

Indications

No indication recorded.