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OpenTrials
Completed

NCT Number: NCT00796965

Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects

Single Ascending Dose Study

Completed

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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

  • Provision of Informed Consent
  • Healthy male subjects and female subjects (of non-child bearing potential) with suitable veins for cannulation or repeated venipuncture

Exclusion criteria

  • Inability to understand or cooperate with given information
  • Positive human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
  • Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology, and urinanalysis

Treatment and study plan

AZD7268

Drug

Solution/Capsule, Oral, once daily

Placebo

Drug

Primary outcomes

  1. To assess the safety and tolerability of single ascending dose administration of AZD7268 when given orally to healthy male subjects and female subjects of non-childbearing potential.

    Time frame: Safety assessments are made at each visit, at least daily, during the study.

Secondary outcomes

  1. To characterize the pharmacokinetics of AZD7268 in plasma and urine.

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

  2. To assess the effect of food on the safety and pharmacokinetic profile of AZD7268.

    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

A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects

Important dates

Study start
2008
Study completion
2009
First posted
Nov 24, 2008
Registry last updated
Aug 19, 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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