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A Drug-Drug Interaction Study to Study the Effect of AZD1981 on Warfarin

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

Condition(s) targeted: Pharmakokinetic

Intervention: AZD1981 (Drug); Warfarin (Drug); AZD1981 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Christer Hultqvist, MD, Study Director, Affiliation: AstraZeneca
Aslak Rautio, Principal Investigator, Affiliation: Quintiles AB
Wofgang Kühn, MD, Principal Investigator, Affiliation: Quintiles AB

Summary

The primary purpose of this study is to determine whether the treatment with AZD1981 affect the exposure of Warfarin.

Clinical Details

Official title: A Phase I, Open Label, Randomised, Parallel Group Study of Repeated Oral Doses of AZD1981 (100 mg Twice Daily and 400 mg Twice Daily) for Two Weeks and Single Doses of Warfarin (25 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Warfarin and the Effect of AZD1981 on Warfarin Pharmacodynamics in Healthy Male Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Pharmacokinetics for (R)- and (S)-Warfarin, respectively measured by Cmax and Area Under the Curve (AUC)

Secondary outcome:

Explore possible changes in the anticoagulative activity of Warfarin measured by INR .

Pharmacokinetics for AZD1981 measured by AUCτ, Css,max, tmax,ss and CLss/F

Safety and tolerability of AZD1981

Eligibility

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

Criteria:

Inclusion Criteria:

- Have a body mass index between 19 and 30 kg/m2 and weight at least 65 kg and no more

than 100 kg

- Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to screening

- Volunteers must be willing to use barrier methods of contraception during study and 3

months after the end of their participation in the study Exclusion Criteria:

- Volunteer that is inferred to have an increased sensitivity to warfarin based on

genotype of CYP2C9 and VKORC1.

- Any clinically significant disease or disorder

- Any clinically relevant abnormal findings in physical examination

Locations and Contacts

Research Site, Uppsala, Sweden
Additional Information

Starting date: October 2010
Last updated: February 8, 2011

Page last updated: August 23, 2015

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