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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00754715
First received: September 16, 2008
Last updated: December 12, 2008
Last verified: December 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Experimental: AZD2516 Drug: AZD2516
Solution administered once orally
Placebo Comparator: Placebo Drug: Placebo
Solution administered only once

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  • History of previous or ongoing psychiatric disease.
  • Abnormalities in ECG that may interfere with interpretation of data.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754715

Locations
Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Bo Fransson, MD AstraZeneca
Study Chair: Lars Ståhle, MD, PhD AstraZeneca
  More Information

No publications provided

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

Keywords provided by AstraZeneca:
Multiple dosing study,
safety

ClinicalTrials.gov processed this record on April 17, 2014