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drugset / Trial / NCT01550458

Safety Study of Mibefradil When Given Four Times a Day in Healthy Volunteers

NCT01550458 ↗

Phase 1 Completed 30 enrolled Cavion, Inc. Celerion · collabDana-Farber Cancer Institute · collabLifeWatch Services, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of the study is to determine the safety and pharmacokinetics of a 7 day course of oral mibefradil given four times a day in healthy volunteers. This is a dose escalation study in which the total daily dose of mibefradil will be increased with each cohort.

Timeline

Start
2012-02
Primary completion
2012-06-24
Completion
2012-06-24

Drugs

EvaluationDrugModalityDoseRoute
Subject mibefradil Small molecule 100 mg Oral
Subject mibefradil Small molecule 125 mg Oral
Subject mibefradil Small molecule 150 mg Oral
Subject mibefradil Small molecule 175 mg Oral
Subject mibefradil Small molecule 200 mg Oral
Subject mibefradil Small molecule 225 mg Oral
Subject mibefradil Small molecule 250 mg Oral
Subject mibefradil Small molecule 275 mg Oral
Subject mibefradil Small molecule 300 mg Oral
Subject mibefradil Small molecule 325 mg Oral
Subject mibefradil Small molecule 350 mg Oral
Subject mibefradil Small molecule 375 mg Oral
Subject mibefradil Small molecule 400 mg Oral

Indications

No indication recorded.