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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics; Pharmacodynamics

Intervention: AZD9668 (Drug); Warfarin (Drug)

Phase: Phase 1

Status: Withdrawn

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Christopher D O'Brien, MD, PhD, Study Director, Affiliation: AstraZeneca R&D
Ingemar Bylesjö, MD, Principal Investigator, Affiliation: Berzelius Clinical Reseach Centre
Wolfgang Kühn, MD, Principal Investigator, Affiliation: Quintiles AB, Phase 1 Services

Summary

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

Clinical Details

Official title: A Phase I, Open Label, Fixed Sequence, Single Centre Study in Healthy Volunteers to Investigate the Effects of Repeated Oral Doses AZD9668 on the Pharmacokinetics and Pharmacodynamics of a Single Dose of Warfarin

Study design: Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Pharmacodynamics measured by maximum international normalised ratio ( INRmax)

Secondary outcome:

Pharmacokinetics for AZD9668 measured by Css,max

Pharmacokinetics for AZD9668 measured by tss,max

Pharmacokinetics for AZD9668 measured by Css,min

Pharmacokinetics for AZD9668 measured by CLss/F

Severity of Adverse Events as a Measure of Safety and Tolerability

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Pharmacokinetics for (R)- and (S)- Warfarin measured tmax.

Pharmacokinetics for (R)- and (S)- Warfarin measured t½.

Pharmacokinetics for (R)- and (S)- Warfarin measured CL/F.

Pharmacokinetics for (R)- and (S)- Warfarin measured Vz/F.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

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 and Contacts

Research Site, Linköping, Sweden

Research Site, Uppsala, Sweden

Additional Information

Starting date: November 2010
Last updated: January 28, 2013

Page last updated: August 23, 2015

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