NCT00487136

Brief Summary

This is a multiple-dose, double-blind, randomized, single-center, parallel-group study in adult male subjects in general good health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2007

Shorter than P25 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

June 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2007

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

September 28, 2012

Status Verified

September 1, 2012

Enrollment Period

1 month

First QC Date

June 13, 2007

Last Update Submit

September 27, 2012

Conditions

Healthy

Keywords

Drug InteractionPharmacokineticsPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters, pharmacodynamic variables

    Day 24

Secondary Outcomes (1)

  • Vital signs, physical examinations, laboratory tests, ECGs, adverse events

    Day 29

Study Arms (3)

Warfarin

ACTIVE COMPARATOR

Warfarin fixed dose plus one capsule containing placebo for ABT-335, one placebo tablet to match rosuvastatin 5 mg and one placebo tablet to match rosuvastatin 20 mg, administered for 10 consecutive days.

Drug: Warfarin

Warfarin plus ABT-335 plus Rosuvastatin

EXPERIMENTAL

Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one 5 mg tablet of rosuvastatin and one tablet of placebo to match rosuvastatin 20 mg, administered for 10 consecutive days.

Drug: warfarin plus ABT-335 plus rosuvastatin 5 mg

Warfarin plus ABT-335 mg plus rosuvastatin 20 mg

EXPERIMENTAL

Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one tablet of placebo to match rosuvastatin 5 mg and one 20 mg tablet of rosuvastatin, administered for 10 consecutive days.

Drug: warfarin plus ABT-335 plus rosuvastatin 20 mg

Interventions

WarfarinDRUG

Warfarin fixed dose plus one capsule containing placebo for ABT-335, one placebo tablet to match rosuvastatin 5 mg and one placebo tablet to match rosuvastatin 20 mg, administered for 10 consecutive days.

Also known as: Coumadin
Warfarin
warfarin plus ABT-335 plus rosuvastatin 5 mgDRUG

Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one 5 mg tablet of rosuvastatin and one tablet of placebo to match rosuvastatin 20 mg, administered for 10 consecutive days.

Also known as: warfarin, coumadin ABT-335, fenofibric acid, Trilipix Rosuvastatin, Crestor
Warfarin plus ABT-335 plus Rosuvastatin
warfarin plus ABT-335 plus rosuvastatin 20 mgDRUG

Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one tablet of placebo to match rosuvastatin 5 mg and one 20 mg tablet of rosuvastatin, administered for 10 consecutive days.

Also known as: warfarin, coumadin, ABT-335, fenofibric acid, Trilipix Rosuvastatin, Crestor
Warfarin plus ABT-335 mg plus rosuvastatin 20 mg

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) is 19 to 29, inclusive.
  • A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
  • Written informed consent prior to the initiation of screening or study-specific procedures.

You may not qualify if:

  • Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
  • Subjects taking concomitant medications.
  • Subjects with a recent history of surgery or trauma.
  • Subjects with a history of any bleeding disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Ref # / Investigator 5290

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Interventions

Warfarin2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acidRosuvastatin Calciumfenofibric acid

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Study Officials

  • Torbjörn Lundström, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 13, 2007

First Posted

June 15, 2007

Study Start

June 1, 2007

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

September 28, 2012

Record last verified: 2012-09

Locations

US(1)