At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 72 enrolled
Drug / intervention
lomitapidedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD) of Lomitapide in Japanese and Caucasian Volunteers With Elevated Low-density-lipoprotein(LDL-C)
In Brief
A Phase 1 clinical trial evaluating lomitapide for Healthy Volunteer. Completed, enrolled 72 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer
CountriesUnited Kingdom
CollaboratorsRichmond Pharmacology Limited
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedJan 2013
Primary CompletionJun 2013
TodayJul 2026
First PostedJan 4, 2013
Enrollment StartNov 7, 2012
Primary CompletionJun 3, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.5 years ago
Interventions
lomitapidedrug