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

NCT01199341 — Phase 1, Completed, 28 participants, AstraZeneca

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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

Registry	NCT01199341
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: none, basic science
Enrollment	28 (Actual)
Sponsor	AstraZeneca (Industry)
Conditions	Pharmakokinetic
Interventions	AZD1981, Warfarin (Drug)
Dates	start 2010-10-01, primary completion 2010-12-01, completion 2010-12-01, first posted 2010-09-10, last updated 2011-02-09
Locations	1 site in Sweden

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Treatment A	Experimental	Drug: AZD1981; Drug: Warfarin	AZD1981, low dose, + Warfarin
Treatment B	Experimental	Drug: Warfarin; Drug: AZD1981	AZD1981, high dose, + Warfarin

AZD1981 (Drug): 100 mg per oral, twice daily for 14 days
Warfarin (Drug), also known as Waran: 10 x 2.5 mg per oral, once daily at day 1 and day 15
AZD1981 (Drug): 4 x 100 mg per oral, twice daily for 14 days

+Outcome measures

Primary outcomes

Pharmacokinetics for (R)- and (S)-Warfarin, respectively measured by Cmax and Area Under the Curve (AUC) [PK sampling will be performed regularly from Day 1 to Day 22]

Secondary outcomes

Explore possible changes in the anticoagulative activity of Warfarin measured by INR . [Will be performed at screening and at all visits during the study period.]
Pharmacokinetics for AZD1981 measured by AUCτ, Css,max, tmax,ss and CLss/F [PK sampling will be performed regularly from Day 15 to Day 22.]
Safety and tolerability of AZD1981 [Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study.]

+Eligibility

Sex: Male, ages: 18 Years to 55 Years, accepts healthy volunteers

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 (1)

Facility	City	Country	Status
Research Site	Uppsala	Sweden

+Investigators

Christer Hultqvist, MD, Study director, AstraZeneca
Aslak Rautio, Principal investigator, Quintiles AB
Wofgang Kühn, MD, Principal investigator, Quintiles AB