AZD5672 Bioavailability Study in Healthy Male and Female Subjects

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871767
• Other study ID #: D1710C00019
• Secondary ID: EudraCt No. 2009
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2009
• Last updated: June 29, 2009
• Start date: March 2009
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• AZD5672
40 mg tablet (Test formulation)
• AZD5672
40 mg tablet (Reference formulation)
• AZD5672
100 mg tablet (Test formulation)
• AZD5672
100 mg (2 x 50 mg tablet (Reference Formulation)

Locations

Country	Name	City	State
United Kingdom	Research Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes