Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects

Healthy Clinical Trial

Official title:

A Phase I, Single-centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics After Oral Single Ascending Doses of AZD2516 in Young and Elderly Japanese Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972049
• Other study ID #: D2080C00004
• Status: Completed
• Phase: Phase 1
• First received: September 3, 2009
• Last updated: March 2, 2010
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: March 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose to Japanese healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Weight between 45 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2

• Japanese males aged between 20 to 45 years old (young) and Japanese males or females aged between 65 to 80 years old (elderly)

Exclusion Criteria:

• History of previous or ongoing somatic or psychiatric disease/condition

• Abnormalities in ECG that may interfere with interpretation of data.

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

Intervention

Drug:
• AZD2516
Capsule administered once orally. Specific dose depends on dose panel.
• Placebo
Capsule administered once orally

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	Safety and tolerability of AZD2516 in Japanese healthy subjects by assessment of adverse events, vital signs, laboratory variables and ECG		Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 3 and follow up visit 3	Yes
Secondary	Investigate the single ascending dose pharmacokinetics of AZD2516 in Japanese subjects		Blood sampling at defined timepoints during residential period and follow-up	No