Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 in Healthy Volunteers (SAD)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00940212
First received: July 14, 2009
Last updated: December 8, 2010
Last verified: December 2010
  Purpose

The primary aim of this study is to investigate the safety and tolerability of AZD2423 single doses in healthy volunteers.


Condition Intervention Phase
Healthy Volunteers
Drug: AZD2423
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 After Single Ascending Doses in Healthy Male and Female Volunteers Without Childbearing Potential

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the safety and tolerability of AZD2423 following administration of single ascending doses and if possible to estimate the maximum tolerated dose (MTD), if within the predefined exposure limits. [ Time Frame: 3 day residential period plus 7-10 days follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterise the pharmacokinetics of AZD2423 and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses ofAZD2423. [ Time Frame: 3 day residential period plus 7-10 days follow up ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: July 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
AZD2423
Drug: AZD2423
oral, single administration
Experimental: B
Placebo
Drug: Placebo
oral administration and single dose

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of signed and dated, written informed consent prior to any study specific procedures
  • Have a body mass index (BMI) between ≥18 and ≤30 kg/m2, as calculated by the investigator, and weigh at least 50 kg and no more than 100 kg
  • Healthy male and non-fertile female volunteers with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study,or influence the results or the subject'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 Principal Investigator, within 3 months of the first administration of investigational product
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940212

Locations
Germany
Research Site
Berlin, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Rainard Fuhr, MD PAREXEL Early Phase Clinical Uniit, Berlin Germany
Study Director: Anders Neijber AstraZeneca R&D Södertälje
  More Information

No publications provided

Responsible Party: Anders Neijber, Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00940212     History of Changes
Other Study ID Numbers: D2600C00001, EudraCT 2009-010364-42
Study First Received: July 14, 2009
Last Updated: December 8, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
Safety
tolerability
healthy
pharmacokinetics

ClinicalTrials.gov processed this record on April 17, 2014