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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01214122
Date of registration: 21/09/2010
Prospective Registration: Yes
Primary sponsor: AstraZeneca
Public title: A Drug-Drug Interaction Study Between AZD9668 and Warfarin to Study the Effect of AZD9668 on the Metabolism and Effect of Warfarin
Scientific 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
Date of first enrolment: November 2010
Target sample size: 0
Recruitment status: Withdrawn
URL:  http://clinicaltrials.gov/show/NCT01214122
Study type:  Interventional
Study design:  Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Basic Science  
Phase:  Phase 1
Countries of recruitment
Sweden
Contacts
Name:     Christopher D O'Brien, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  AstraZeneca R&D
Name:     Wolfgang Kühn, MD
Address: 
Telephone:
Email:
Affiliation:  Quintiles AB, Phase 1 Services
Name:     Ingemar Bylesjö, MD
Address: 
Telephone:
Email:
Affiliation:  Berzelius Clinical Reseach Centre
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Male
Health Condition(s) or Problem(s) studied
Pharmacokinetics
Pharmacodynamics
Intervention(s)
Drug: Warfarin
Drug: AZD9668
Primary Outcome(s)
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 21]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 22]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) 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 20]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 1]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 11]
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 23]
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]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 10]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 15]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 4]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 5]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 7]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 12]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 13]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 19]
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 10]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 8]
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 11]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 9]
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]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) 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 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 9]
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 19]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 14]
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 12]
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 21]
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 16]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 17]
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) [Time Frame: Pharmacokinetic (PK) sampling will be performed day 17]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 20]
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 8]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 23]
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 22]
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 4]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 16]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) sampling will be performed day 18]
Pharmacodynamics measured by maximum international normalised ratio ( INRmax) [Time Frame: International normalised ratio (INR) 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 13]
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 14]
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 15]
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 18]
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]
Secondary Outcome(s)
Pharmacokinetics for (R)- and (S)- Warfarin measured Vz/F. [Time Frame: Range from day 1 to 23]
Pharmacokinetics for AZD9668 measured by Css,min [Time Frame: Range from day 9 to 23]
Pharmacokinetics for (R)- and (S)- Warfarin measured CL/F. [Time Frame: Range from day 1 to 23]
Pharmacokinetics for (R)- and (S)- Warfarin measured t½. [Time Frame: Range from day 1 to 23]
Pharmacokinetics for AZD9668 measured by CLss/F [Time Frame: Range from day 9 to 23]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: Adverse events will be collected pre-dose, during treatment and at follow up]
Severity of Adverse Events as a Measure of Safety and Tolerability [Time Frame: Adverse events will be collected pre-dose, during treatment and at follow up]
Pharmacokinetics for AZD9668 measured by Css,max [Time Frame: Range from day 9 to 23]
Pharmacokinetics for (R)- and (S)- Warfarin measured tmax. [Time Frame: Range from day 1 to 23]
Pharmacokinetics for AZD9668 measured by tss,max [Time Frame: Range from day 9 to 23]
Secondary ID(s)
2010-022360-12
D0520C00013
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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