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This Study Will Assess the Safety and Tolerability of AZD8418 After Single Increasing Oral Doses

This study has been terminated.
(Pre-Clinical Safety Tox Findings)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01027234
First Posted: December 7, 2009
Last Update Posted: May 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
December 4, 2009
December 7, 2009
May 26, 2010
November 2009
March 2010   (Final data collection date for primary outcome measure)
To assess the safety and tolerability of AZD8418 following the oral administration of single ascending doses and to estimate the maximum tolerated dose in healthy volunteers. [ Time Frame: Safety assessments will be obtained daily throughout the study ]
Same as current
Complete list of historical versions of study NCT01027234 on ClinicalTrials.gov Archive Site
  • To characterise the pharmacokinetics of AZD8418 and its metabolites in plasma and urine, and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses of AZD8418. [ Time Frame: samples will be obtained pre and post dose ]
  • To assess the effect of food on the safety and pharmacokinetic profile of AZD8418 and its metabolites. [ Time Frame: samples will be obtained pre and post dose ]
Same as current
Not Provided
Not Provided
 
This Study Will Assess the Safety and Tolerability of AZD8418 After Single Increasing Oral Doses
A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Single-ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and Pharmacokinetics (Part A) and an Open-label Assessment of the Effect of Food on the Pharmacokinetics (Part B) of Orally Administered AZD8418

The main purpose of this study is to assess the safety and tolerability of AZD8418 after single increasing oral doses.

Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves the body and how your body acts on the study drug) of AZD8418. Part B of the study will assess the effect of food on the safety and pharmacokinetics of AZD8418.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: AZD8418
    Single oral dose
  • Drug: Placebo
    single oral dose
  • Experimental: 1
    Intervention: Drug: AZD8418
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male volunteers
  • Healthy female volunteers of non-childbearing potential

Exclusion Criteria:

  • History of any clinically significant medical, neurologic, or psychiatric disease (including repeated episodes of major depression) or a disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8418
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01027234
D2590C00001
No
Not Provided
Not Provided
MSD, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Philip T. Leese, M.D. Quintiles, Inc.
AstraZeneca
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP