Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 Multiple Doses in Healthy Japanese Volunteers

Healthy Clinical Trial

Official title:

A Phase I, Single Centre, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 Solution After Administration of Multiple Ascending Doses for 12 Days in Young and Elderly Healthy Japanese Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233830
• Other study ID #: D2600C00004
• Status: Completed
• Phase: Phase 1
• First received: October 19, 2010
• Last updated: April 11, 2011
• Start date: November 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD2423 in young and elderly healthy Japanese volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Provision of signed and dated, written informed consent prior to any study specific procedures

• Healthy Japanese male volunteers aged =20 to =45 years and healthy Japanese male and female volunteers aged =65 to =80 years with suitable veins for cannulation or repeated venipuncture

• Have a body mass index (BMI) between =17 and =27 kg/m2, as calculated by the investigator(s), and weigh at least 45 kg and no more than 100 kg

• Clinically normal physical findings including supine blood pressure, pulse rate, ECG, and laboratory assessments in relation to age, as judged by the investigator(s)

Exclusion Criteria:

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

• History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

• Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the investigator(s), within 3 months of the first administration of investigational product or known malignancy within the past 5 years (with the exception of successfully treated basal cell carcinoma)

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD2423
oral solution
• Placebo
oral solution

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse events		Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)	Yes
Primary	Vital signs	Changes from baseline in systolic blood pressure, pulse rate and body temperature	Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)	Yes
Primary	Electrocardiograms		Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)	Yes
Primary	Laboratory Variables (hematology, urinalysis and clinical chemistry)		Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)	Yes
Secondary	Plasma concentration over time		Pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours after the first dose	No