Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00754715

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: AZD2516 Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables [ Time Frame: From first to last visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety and tolerability of AZD2516 by assessment of non-serious adverse events [ Time Frame: Collected from start of residential period until last visit. ] [ Designated as safety issue: Yes ]
Determine the single ascending dose pharmacokinetics of AZD2516 [ Time Frame: PK sampling taken at defined timepoints during residential period ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	September 2008
Study Completion Date:	December 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AZD2516: Experimental	Drug: AZD2516 Solution administered once orally
Placebo: Placebo Comparator	Drug: Placebo Solution administered only once

Eligibility

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754715

Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Bo Fransson, MD	AstraZeneca
Study Chair:	Lars Ståhle, MD, PhD	AstraZeneca

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia )
Study ID Numbers:	D2080C00001, EudractCT: 2008-003598-42
Study First Received:	September 16, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00754715
Health Authority:	Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:

Multiple dosing study,
safety

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 13, 2009