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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: AZD8418; Drug: Placebo

• Registration Number: NCT01027234
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-04
• Study First Submitted QC: 2009-12-04
• Study First Posted: 2009-12-07
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-25
• Last Update Posted: 2010-05-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD8418	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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.	Safety assessments will be obtained daily throughout the study

Secondary Outcome Measures

Name	Time	Method
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.	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.	samples will be obtained pre and post dose

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States