NCT01214122 - A Drug-Drug Interaction Study Between AZD9668 and Warfarin to Study the Effect of AZD9668 on the Metabolism and Effect of Warfarin | Crick | Crick

A Drug-Drug Interaction Study Between AZD9668 and Warfarin to Study the Effect of AZD9668 on the Metabolism and Effect of Warfarin

Phase 1WithdrawnNCT01214122

AstraZeneca

Overview

The primary purpose of this study is to determine whether the treatment with AZD9668 will affect the metabolism and effect of Warfarin.

Study Type

INTERVENTIONAL

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Pharmacokinetics Pharmacodynamics

Interventions

60 mg orally twice daily for 11 days

10 x 2.5 (25) mg orally once daily on day 1 and on day 14

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of signed informed consent (including genotyping screening sample for CYP2C9 and VKORC1) prior to any study specific procedures * Subjects must be willing to use a barrier method of contraception, unless their partners are post-menopausal or surgically sterile, or if a female partner is of childbearing potential the subject must use a barrier method of contraception (condom) and the partner must use accepted contraceptive methods (oral contraceptive, implant, long term injectable contraceptive or intrauterine device), from first dose of IP (warfarin and AZD9668) until 3 months after last dose of IP (warfarin and AZD9668) * Have a body mass index between 19 and 30 kg/m2 (inclusive) and a weight between 50 and 100 kg (inclusive) * Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1. Exclusion Criteria: * Any clinically significant disease or disorder * Subject predicted to have high sensitivity to warfarin based on CYP2C9 and VKORC1 genotypes * Any clinically relevant abnormal findings in physical examination

Locations (2)

Research Site

Linköping, Sweden

Research Site

Uppsala, Sweden

Outcomes

Primary Outcomes

Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)

Time frame: Pharmacokinetic (PK) sampling will be performed day 1

Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)

Time frame: Pharmacokinetic (PK) sampling will be performed day 2

Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)

Time frame: Pharmacokinetic (PK) sampling will be performed day 3

Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)

Time frame: Pharmacokinetic (PK) sampling will be performed day 4

Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)

Time frame: Pharmacokinetic (PK) sampling will be performed day 5

Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)

Time frame: Pharmacokinetic (PK) sampling will be performed day 6

Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)

Time frame: Pharmacokinetic (PK) sampling will be performed day 7

Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)

Data from ClinicalTrials.gov

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