drugset
drugset / Trial / NCT01760187

Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C

NCT01760187 ↗

Phase 1 Completed 72 enrolled Aegerion Pharmaceuticals, Inc. Richmond Pharmacology Limited · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study of orally administered lomitapide in healthy male Japanese and Caucasian subjects with elevated LDL-C. The purpose for this study is to evaluate the PK and PD of lomitapide in Japanese subjects as compared to Caucasian subjects.

Timeline

Start
2012-11-07
Primary completion
2013-06-03
Completion
2013-06-03

Drugs

EvaluationDrugModalityDoseRoute
Subject lomitapide Small molecule 10 mg Oral
Subject lomitapide Small molecule 20 mg Oral
Subject lomitapide Small molecule 40 mg Oral
Subject lomitapide Small molecule 60 mg Oral

Indications

No indication recorded.