Completed PHASE1 INTERVENTIONAL 4-arm NCT01760187

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

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)

Sponsor: Aegerion Pharmaceuticals, Inc.

Conditions Healthy Volunteer

Interventions lomitapide

Updated 9 times since 2017 Last updated: Nov 16, 2018 Started: Nov 7, 2012 Primary completion: Jun 3, 2013 Completion: Jun 3, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Healthy Volunteer and is currently completed. Aegerion Pharmaceuticals, Inc. leads this study, which shows 9 recorded versions since 2012 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

9 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2023 — Jul 2024 [monthly]

Completed PHASE1
Dec 2022 — Jan 2023 [monthly]

Completed PHASE1
Jan 2021 — Dec 2022 [monthly]

Completed PHASE1

▶ Show 4 earlier versions

Dec 2018 — Jan 2021 [monthly]

Completed PHASE1
Jun 2018 — Dec 2018 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1
Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Nov 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Aegerion Pharmaceuticals, Inc.
Richmond Pharmacology Limited

Data source: Aegerion Pharmaceuticals, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Croydon, United Kingdom