AZD5672 Absolute Bioavailability Study

Healthy Volunteers Clinical Trial

Official title:

A Phase I Study to Assess Absolute Bioavailability of AZD5672 at Steady-state in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746837
• Other study ID #: D1710C00018
• Secondary ID: EudraCt nr 2008-
• Status: Completed
• Phase: Phase 1
• First received: September 3, 2008
• Last updated: November 30, 2010
• Start date: August 2008
• Est. completion date: January 2009

Study information

• Verified date: November 2010
• 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 purpose of the study is to estimate the absolute bioavailability at steady state of 2 doses of AZD5672 (50 mg and 150 mg administered orally once daily)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2009
• Est. primary completion date: January 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.

• Females should not be of childbearing potential

• Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results

Exclusion Criteria:

• Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate

• Unsuitable venous access for intravenous studies

• Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AZD5672
single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period
• AZD5672
50 mg od, 12 days
• AZD5672
150mg od, 12 days

Locations

Country	Name	City	State
United Kingdom	Research Site	Harrow	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK variables		Frequent sampling occasions during study periods	No
Secondary	Safety variables (adverse events, blood pressure, pulse, safety lab)		During the whole treatment periods	Yes