NCT00826358

Brief Summary

The purpose of this study is to evaluate the safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at 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

First Submitted

Initial submission to the registry

October 21, 2008

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
Last Updated

September 28, 2012

Status Verified

September 1, 2012

Enrollment Period

Same day

First QC Date

October 21, 2008

Last Update Submit

September 27, 2012

Conditions

Healthy

Keywords

Adverse eventsPharmacokinetic

Outcome Measures

Primary Outcomes (2)

  • To determine the safety and tolerability of ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults.

    7 days

  • To determine the pharmacokinetic profile for ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults.

    7 days

Study Arms (2)

A

EXPERIMENTAL

ABT-143 capsules 5/45mg

Drug: ABT-143

B

ACTIVE COMPARATOR

ABT-335 45mg and rosuvastatin 5mg

Drug: ABT-335Drug: rosuvastatin

Interventions

ABT-143DRUG

Once, please see Arm Description for more details.

A
ABT-335DRUG

Once, see Arm Description for more detail

B
rosuvastatinDRUG

once, see Arm Description for more detail

B

Eligibility Criteria

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

You may qualify if:

  • A condition of general good health
  • BMI 19 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# 13441

Orlando, Florida, 32809, United States

Location

MeSH Terms

Interventions

2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acidRosuvastatin Calcium

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Torbjörn Lundström, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 21, 2008

First Posted

January 22, 2009

Study Start

November 1, 2008

Primary Completion

November 1, 2008

Last Updated

September 28, 2012

Record last verified: 2012-09

Locations

US(1)