NCT00359281

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for phase_2 healthy

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

March 4, 2014

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

1.7 years

First QC Date

July 31, 2006

Results QC Date

January 18, 2013

Last Update Submit

February 21, 2018

Conditions

Healthy

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (10)

  • Area Under Concentration-time Curve From 0 to Last Measureable Concentration (AUC0-t) Atorvastatin Acid (Lomitapide 10 mg)

    Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 10 mg)

    0 to 24 hour

  • AUC0-t Simvastatin

    Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin

    0 to 24 hours

  • AUC0-t Simvastatin Acid

    Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin acid

    0 to 24 hours

  • AUC0-t Total Ezetimibe

    Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for total ezetimibe

    0 to 24 hours

  • AUC0-t Rosuvastatin (Lomitapide 10 mg)

    Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 10 mg)

    0 to 24 hours

  • AUC0-t Fenofibric Acid

    Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for fenofibric acid

    0 to 24 hours

  • AUC0-t Atorvastatin Acid (Lomitapide 60 mg)

    Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 60 mg)

    0 to 24 hours

  • AUC0-t Rosuvastatin (Lomitapide 60 mg)

    Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 60 mg)

    0 to 24 hours

  • AUC0-t Nicotinic Acid

    Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinic acid

    0 to 24 hours

  • AUC0-t Nicotinuric Acid

    Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinuric acid

    0 to 24 hours

Secondary Outcomes (1)

  • Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)

    Baseline to Day 8

Interventions

atorvastatinDRUG

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

simvastatinDRUG

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

ezetimibeDRUG

Ezetimibe 10 mg and AEGR-733 10 mg

fenofibrateDRUG

Micronized Fenofibrate 145 mg and AEGR-733 10 mg

dextromethorphanDRUG

Dextromethorphan 30 mg and AEGR-733 10 mg

Extended Release NiacinDRUG

1000 mg ER niacin and AEGR-733 10 mg

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and non-pregnant/non-lactating female subjects between the ages of 18 and 70 who are in good overall health.
  • To be eligible for enrollment in this study, patients must meet all of the following criteria:
  • Men and women between the ages of 18 and 70
  • Women of child-bearing potential, that is, women not surgically sterilized and between menarche and 1 year post menopause, must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of non-medication birth control (for example, a reliable barrier method of birth control \[diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices\]; partner with vasectomy; or abstinence) during the study and for one month following the last dose of study drug.
  • Subjects must be in good overall health
  • Subjects must be able to comprehend and willing to provide a signed IRB approved Informed Consent Form.
  • Subjects must be willing to comply with all study-related procedures.

You may not qualify if:

  • Known atherosclerotic cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease
  • History of diabetes mellitus or fasting glucose \> 126 mg/dL at the screening visit.
  • History of a non-skin malignancy within the previous 5 years
  • Renal insufficiency as defined by creatinine \> 1.3 mg/dl
  • Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition
  • History of hypertension
  • Known coagulopathy and /or elevated PT/PTT \>1.5 x ULN
  • Oral history of HIV positive
  • Patients who have undergone any organ transplant
  • Known active fibrotic or cirrhotic disease; ALT or AST \> 1.5x ULN
  • Any major surgery within the previous 3 months
  • Individuals who currently use tobacco products or have done so in the previous 30 days
  • History of drug abuse (\< 3 years)
  • Regular use of alcoholic beverages (\> 7 drinks/day)
  • Subjects who do not agree to abstain from consuming alcoholic beverages during the entire study duration.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

AtorvastatinSimvastatinEzetimibeFenofibrateDextromethorphan

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAzetidinesAzetinesFibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsPhenyl EthersEthersBenzophenonesBenzene DerivativesPhenolsKetonesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenes

Results Point of Contact

Title
Mark Sumeray, MD, Chief Medical Officer
Organization
Aegerion Pharmaceuticals
msumeray@aegerion.com
617-500-7867

Study Officials

  • Marina Cuchel, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2006

First Posted

August 2, 2006

Study Start

March 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

February 23, 2018

Results First Posted

March 4, 2014

Record last verified: 2018-02

Locations

US(1)