AZD5672 Bioavailability Study in Healthy Male and Female Subjects

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00871767

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to compare the blood levels achieved with a new formulation of AZD5672 to an existing formulation of AZD5672 used in previous studies

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: AZD5672 Drug: AZD5672 Drug: AZD5672 Drug: AZD5672	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

An Open-Label, Randomized, 4 Period Crossover, Replicate Study to Assess the Relative Bioavailability of the Phase III and Phase IIb Formulations of AZD5672 in Healthy Male and Female Subjects

Study Start Date :

Mar 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 40 or 100mg AZD5672, Reference formulation	Drug: AZD5672 40 mg tablet (Reference formulation) Drug: AZD5672 100 mg (2 x 50 mg tablet (Reference Formulation)
Experimental: 2 40 or 100mg AZD5672, Test formulation	Drug: AZD5672 40 mg tablet (Test formulation) Drug: AZD5672 100 mg tablet (Test formulation)

Arm

Intervention/Treatment

Experimental: 1

40 or 100mg AZD5672, Reference formulation

Drug: AZD5672

40 mg tablet (Reference formulation)

Drug: AZD5672

100 mg (2 x 50 mg tablet (Reference Formulation)

Experimental: 2

40 or 100mg AZD5672, Test formulation

Drug: AZD5672

40 mg tablet (Test formulation)

Drug: AZD5672

100 mg tablet (Test formulation)

Outcome Measures

Primary Outcome Measures

Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss [Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28]

Secondary Outcome Measures

Safety variables (adverse events, blood pressure, pulse, safety lab) [AE assessed throughout whole the study, twice weekly assessment of BP, pulse and safety labs throughout study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Provision of informed consent prior to any study-specific procedures
BMI between 18 and 30 kg/m2
Medical and surgical history and physical examination without any clinically significant findings
Non smokers or past smokers who have stopped smoking within the last 6 months.

Exclusion Criteria:

History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product.
Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding