NCT00681525

Brief Summary

The objective of this study is to evaluate the potential PK interaction between ABT-335, atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

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

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Last Updated

October 19, 2010

Status Verified

September 1, 2010

Enrollment Period

2 months

First QC Date

May 19, 2008

Last Update Submit

October 18, 2010

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • PK interaction

    Study duration approximately 62 days

Study Arms (3)

A

EXPERIMENTAL

ABT-335 135 mg

Drug: ABT-335

B

EXPERIMENTAL

Atorvastatin 80 mg and Ezetimibe 10 mg

Drug: AtorvastatinDrug: Ezetimibe

C

EXPERIMENTAL

ABT-335 135 mg, Atorvastatin 80 mg and Ezetimibe 10 mg

Drug: ABT-335Drug: AtorvastatinDrug: Ezetimibe

Interventions

ABT-335DRUG

One ABT-335 135 mg capsule QD for 10 days

Also known as: fenofibric acid
AC
AtorvastatinDRUG

One 80 mg tablet of atorvastatin QD for 10 days

Also known as: atovastatin
BC
EzetimibeDRUG

One ezetimibe 10 mg tablet QD for 10 days

BC

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female subjects

You may not qualify if:

  • Clinically significant diseases or disorders
  • Positive screens for drug and alcohol
  • Pregnant or breast-feeding females
  • Any history of surgery(ies) that might interfere with the gastrointestinal motility, pH or absorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 8087

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Interventions

2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acidfenofibric acidAtorvastatinEzetimibe

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsAzetidinesAzetines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 19, 2008

First Posted

May 21, 2008

Study Start

April 1, 2008

Primary Completion

June 1, 2008

Last Updated

October 19, 2010

Record last verified: 2010-09

Locations

US(1)