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Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents

NCT00359281 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2018-02-23

Study results available
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Summary

This phase II, open-label research study was conducted in 129 healthy volunteers. Each subject will be given one initial oral dose of one of 7 FDA-approved medications (probe drugs), followed by a 7 day period where subjects receive the study medication AEGR-733 at 10 or 60 mg. On study day 8 subjects will receive the second oral dose of the same probe drug that was given on day 1 and a last dose of AEGR-733 (total of 7 doses).Subjects will return in 1 week for a final safety visit. Each FDA- approved probe drug will be given to ten (10) or fifteen (15) subjects.

Safety, pharmacokinetic and pharmacodynamic assessments will be performed.

Conditions

  • Healthy

Interventions

DRUG

atorvastatin

Atrovastatin 20 mg and AEGR-733 10 mg or 60 mg

DRUG

simvastatin

Simvastatin 20 mg and AEGR-733 10 mg or 60 mg

DRUG

ezetimibe

Ezetimibe 10 mg and AEGR-733 10 mg

DRUG

fenofibrate

Micronized Fenofibrate 145 mg and AEGR-733 10 mg

DRUG

dextromethorphan

Dextromethorphan 30 mg and AEGR-733 10 mg

DRUG

Extended Release Niacin

1000 mg ER niacin and AEGR-733 10 mg

Sponsors & Collaborators

  • Aegerion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Marina Cuchel, MD, PhD · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00359281 on ClinicalTrials.gov