Interaction Between ABT-335, Rosuvastatin and Warfarin

Multiple-Dose Pharmacokinetic and Pharmacodynamic Interaction Between ABT-335, Rosuvastatin and Warfarin

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00487136

Enrollment

Registered

2007-06-15

Start date

2007-06-30

Completion date

2007-07-31

Last updated

2012-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Drug Interaction, Pharmacokinetics, Pharmacodynamics

Brief summary

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

Interventions

DRUGWarfarin

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.

DRUGwarfarin plus ABT-335 plus rosuvastatin 5 mg

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.

DRUGwarfarin plus ABT-335 plus rosuvastatin 20 mg

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters, pharmacodynamic variables	Day 24

Secondary

Measure	Time frame
Vital signs, physical examinations, laboratory tests, ECGs, adverse events	Day 29

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026