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OpenTrials
Completed

NCT Number: NCT00755378

AZD8529 Single Ascending Dose Study

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after single ascending doses

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female subjects aged 18 to 45 years (inclusive) on Day 1. Female subjects must be of non-child bearing potential.

Exclusion criteria

  • Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of investigational prod
  • Plasma donation within one month of screening or any blood donation/blood loss > 500mL during the 3 months prior to screening
  • Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Treatment and study plan

AZD8529

Drug

Oral

Placebo

Drug

Oral

Primary outcomes

  1. To assess the safety and tolerability of single dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.

    Time frame: at each visit, at least daily, during the study.

Secondary outcomes

  1. To characterize the pharmacokinetics of AZD8529 in plasma and urine.

    Time frame: Blood and urine samples will be taken during the study.

  2. To asses the effect of food on the safety and pharmacokinetic profile of AZD8529.

    Time frame: Safety assessments and blood and urine samples will be taken throughout the study.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Phase I, Single-Center, Randomized, Double-Blind, Placebo Controlled Single-Ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and PK of AZD8529 in Healthy Subjects Part B: A Randomized, Open Label Study to Assess the Effect of Food on AZD 8529

Acronym: SAD

Important dates

Study start
2008
Study completion
2009
First posted
Sep 19, 2008
Registry last updated
Mar 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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