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
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: AZD8418
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: November 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD8418
Single oral dose
Placebo Comparator: 2 Drug: Placebo
single oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027234

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Philip T. Leese, M.D. Quintiles
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01027234     History of Changes
Other Study ID Numbers: D2590C00001
Study First Received: December 4, 2009
Last Updated: May 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Healthy volunteers

ClinicalTrials.gov processed this record on August 27, 2014