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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: AZD3241; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00729443

EudractCT# 2008-002466-62

D0490C00012

Details and patient eligibility

About

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

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD3241

2

Placebo Comparator group

Treatment:

Drug: Placebo