NCT00839293

Brief Summary

The purpose of this study is to evaluate the safety and compare the bioavailability of fenofibric acid from 2 different dosage strengths of ABT-335.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

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

February 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Last Updated

October 15, 2010

Status Verified

September 1, 2010

Enrollment Period

28 days

First QC Date

February 6, 2009

Last Update Submit

October 14, 2010

Conditions

Healthy

Keywords

Bioavailability

Outcome Measures

Primary Outcomes (2)

  • To determine the bioavailability of ABT-335 in healthy subjects as measured by timed pharmacokinetic blood draws from pre-dose (0 hour) to 120 hours post dose

    14 Days

  • To evaluate the safety and tolerability of ABT-335 in healthy adults after single dosage

    14 Days

Study Arms (2)

A

EXPERIMENTAL

ABT -335 capsules 135mg

Drug: ABT-335

B

EXPERIMENTAL

ABT-335 capsules 45mg

Drug: ABT-335

Interventions

ABT-335DRUG

Once, see arm description for more information

Also known as: fenofibric acid, Trilipix
AB

Eligibility Criteria

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

You may qualify if:

  • A condition of general good health
  • BMI 18 to 29

You may not qualify if:

  • Currently enrolled in another clinical study
  • Females who are pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 16862

Waukegan, Illinois, 60085, United States

Location

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetones

Study Officials

  • Maureen Kelly, MD

    Abbott

    STUDY DIRECTOR

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

February 6, 2009

First Posted

February 9, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2009

Last Updated

October 15, 2010

Record last verified: 2010-09

Locations

US(1)