Interaction Between ABT-335, Rosuvastatin and Warfarin

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Warfarin; Drug: warfarin plus ABT-335 plus rosuvastatin 5 mg; Drug: warfarin plus ABT-335 plus rosuvastatin 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00487136

M06-887

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Warfarin

Active Comparator group

Description:

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.

Treatment:

Drug: Warfarin

Warfarin plus ABT-335 plus Rosuvastatin

Experimental group

Description:

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.

Treatment:

Drug: warfarin plus ABT-335 plus rosuvastatin 5 mg

Warfarin plus ABT-335 mg plus rosuvastatin 20 mg

Experimental group

Description:

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.

Treatment:

Drug: warfarin plus ABT-335 plus rosuvastatin 20 mg