Investigating Safety, Tolerability and Pharmakinetics When Giving Single and Fractionated Doses of AZD3241 to Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: AZD3241; Drug: Placebo

• Registration Number: NCT00729443
• Lead Sponsor: AstraZeneca

Brief Summary

The study is carried out in order to investigate safety, tolerability and pharmacokinetics after administrating single and fractionated doses of AZD3241 to healthy volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-04
• Study First Submitted QC: 2008-08-06
• Study First Posted: 2008-08-07
• Status Verified: 2008-11
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Last Update Submitted: 2008-11-10
• Last Update Posted: 2008-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Provision of informed consent
• Body Mass Index (BMI) 19 to 30 kg/m2 inclusive
• Clinically normal physical findings, including BP, pulse rate, ECG and laboratory findings, as judged by the investigator

Exclusion Criteria

• Clinically significant illness within the 2 weeks prior to the administration of the investigational product
• Heart rate (resting, recumbent) <50 bmp or >85 bmp
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity as judged by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD3241	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
General tolerability and safety variables	2 weeks

Secondary Outcome Measures

Name	Time	Method
pk	approximately 48 hour

Trial Locations

Locations (1)

Research Site; 🇸🇪 Stockholm, Sweden