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OpenTrials
Completed

NCT Number: NCT00861718

Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy Volunteers

Multiple Ascending Dose Study

Completed

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Key information

Conditions

Healthy

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
  • Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
  • History of seizure (including infancy febrile seizures) or family history of seizure

Treatment and study plan

AZD7268

Drug

Capsule, Oral, QD

Placebo

Drug

Capsule, Oral BID

Primary outcomes

  1. To assess the safety and tolerability of AZD7268 when given orally in multiple ascending doses 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.

    Time frame: Serial blood samples for pharmacokinetic analysis will be collected on Days 1,2,3 and Days 9, 10, and 11 of the study. Additional pharmacokinetic samples will be collected on Days 6, 7, and 8

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 When Given in Multiple Ascending Oral Doses in Healthy Subjects

Important dates

Study start
2009
Study completion
2009
First posted
Mar 13, 2009
Registry last updated
Dec 10, 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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