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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD7268; Drug: Placebo

• Registration Number: NCT00861718
• Lead Sponsor: AstraZeneca

Brief Summary

Multiple Ascending Dose Study

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Study Start: 2009-04
• Study Completion: 2009-10
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-09
• Last Update Posted: 2009-12-10

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD7268	AZD7268	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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.	Safety assessments are made at each visit, at least daily, during the study.

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetics of AZD7268 in plasma.	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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Philadelphia, Pennsylvania, United States