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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01027234

Enrollment

Registered

2009-12-07

Start date

2009-11-30

Completion date

2010-03-31

Last updated

2010-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy volunteers

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.

Interventions

DRUGAZD8418

Single oral dose

DRUGPlacebo

single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026