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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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01027234
First received: December 4, 2009
Last updated: May 25, 2010
Last verified: May 2010

December 4, 2009
May 25, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01027234
D2590C00001
No
MSD, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Philip T. Leese, M.D. Quintiles
AstraZeneca
May 2010

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