NCT00681395

Brief Summary

To evaluate 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
64

participants targeted

Target at P75+ 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

May 1, 2008

Completed
18 days 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
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Last Updated

September 28, 2012

Status Verified

September 1, 2012

Enrollment Period

3 months

First QC Date

May 19, 2008

Last Update Submit

September 27, 2012

Conditions

Adverse EventsPharmacokinetic

Outcome Measures

Primary Outcomes (2)

  • Adverse event and safety laboratory assessments

    7 days

  • Pharmacokinetic parameters

    7 days

Study Arms (4)

1

EXPERIMENTAL

ABT-143 capsules 20/135 mg

Drug: ABT-143

2

ACTIVE COMPARATOR

ABT-335 135mg and rosuvastatin 20mg

Drug: ABT-335Drug: Rosuvastatin

3

EXPERIMENTAL

ABT-143 capsules 5/45mg

Drug: ABT-143

4

ACTIVE COMPARATOR

ABT-335 45mg and rosuvastatin 5mg

Drug: ABT-335Drug: Rosuvastatin

Interventions

ABT-143DRUG

once daily for 6 days

13
ABT-335DRUG

once daily for six days

24
RosuvastatinDRUG

Once daily for 6 days

24

Eligibility Criteria

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

You may qualify if:

  • General good health
  • BMI 19 to 29

You may not qualify if:

  • Currently enrolled in another study
  • Females who are pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 8089

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

May 19, 2008

First Posted

May 21, 2008

Study Start

May 1, 2008

Primary Completion

August 1, 2008

Last Updated

September 28, 2012

Record last verified: 2012-09

Locations

US(1)