Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers

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 of AZD2516 in Young and Elderly Healthy Volunteers After Oral Single Ascending Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754715
• Other study ID #: D2080C00001
• Secondary ID: EudractCT: 2008-
• Status: Completed
• Phase: Phase 1
• First received: September 16, 2008
• Last updated: December 12, 2008
• Start date: September 2008
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy white males or non-fertile females between 20 to 45 years and 65 to 80 years old.

• Weight between 50 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2

Exclusion Criteria:

• History of previous or ongoing psychiatric disease.

• 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
Solution administered once orally
• Placebo
Solution administered only once

Locations

Country	Name	City	State
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables		From first to last visit	Yes
Secondary	Safety and tolerability of AZD2516 by assessment of non-serious adverse events		Collected from start of residential period until last visit.	Yes
Secondary	Determine the single ascending dose pharmacokinetics of AZD2516		PK sampling taken at defined timepoints during residential period	No