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

Phase 1

Withdrawn

• Conditions: Pharmacokinetics; Pharmacodynamics
• Interventions: Drug: Warfarin; Drug: AZD9668

• Registration Number: NCT01214122
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-21
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Study Start: 2010-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment B	Warfarin	Warfarin - 10 x2.5 mg tablets
Treatment A	AZD9668	AZD9668 - 2 x30mg tablets

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)	Pharmacokinetic (PK) sampling will be performed day 23
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)	International normalised ratio (INR) sampling will be performed day 23

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics for AZD9668 measured by Css,max	Range from day 9 to 23
Pharmacokinetics for AZD9668 measured by tss,max	Range from day 9 to 23
Pharmacokinetics for AZD9668 measured by Css,min	Range from day 9 to 23
Pharmacokinetics for AZD9668 measured by CLss/F	Range from day 9 to 23
Severity of Adverse Events as a Measure of Safety and Tolerability	Adverse events will be collected pre-dose, during treatment and at follow up
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Adverse events will be collected pre-dose, during treatment and at follow up
Pharmacokinetics for (R)- and (S)- Warfarin measured tmax.	Range from day 1 to 23
Pharmacokinetics for (R)- and (S)- Warfarin measured t½.	Range from day 1 to 23
Pharmacokinetics for (R)- and (S)- Warfarin measured CL/F.	Range from day 1 to 23
Pharmacokinetics for (R)- and (S)- Warfarin measured Vz/F.	Range from day 1 to 23

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden