AZD2423 Single Ascending Dose Study in Healthy Japanese Subjects

Healthy Volunteer Clinical Trial

— JSAD  

Official title:

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 After Single Ascending Doses in Healthy Japanese Male and Non-Fertile Female Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970775
• Other study ID #: D2600C00003
• Status: Completed
• Phase: Phase 1
• First received: September 1, 2009
• Last updated: March 17, 2010
• Start date: August 2009
• Est. completion date: December 2009

Study information

• Verified date: March 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

This is a Phase I, single centre, randomised, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability and pharmacokinetics of AZD2423 following single ascending dose administration to healthy Japanese subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy Japanese male and non-fertile female subjects aged =20 to =55 years with suitable veins for cannulation or repeated venepuncture.

• Body weight 45-90 kg and Body mass index (BMI) =18.0 and =27.0 kg/m2

• Clinically normal physical findings including supine blood pressure, pulse rate, orthostatic blood pressure, ECG, and laboratory assessments in relation to age, as judged by the Investigator.

Exclusion Criteria:

• History of 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 influence the results or the subject's ability to participate in the study.

• Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 3 months of the first administration of investigational product.

• Frequent use of tobacco or other nicotine containing products. Frequent use is defined as smoking or consumption/intake of nicotine products more than two days per week during the last 12 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• AZD2423
oral solution, single dose
• Placebo
oral solution,single dose

Locations

Country	Name	City	State
United Kingdom	Research Site	Croydon
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables.		From screening period to follow-up visit, 40 days (Maximum).	No
Secondary	To characterize the pharmacokinetics of AZD2423 in plasma and urine.		Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately)	No
Secondary	Exploratory endpoints;Levels of CCL2 pre-and post dose		Blood sampling after dosing, 3 days	No