AZD5672 Bioavailability Study in Healthy Male and Female Subjects

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: AZD5672

• Registration Number: NCT00871767
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-30
• Study Completion: 2009-05
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-29
• Last Update Posted: 2009-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD5672	40 or 100mg AZD5672, Reference formulation
2	AZD5672	40 or 100mg AZD5672, Test formulation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Manchester, United Kingdom