Investigate the Safety Tolerability and Pharmacokinetics of Multiple Doses of AZD1236

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: AZD1236; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00767052

D4260C00006

Details and patient eligibility

About

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of multiple ascending oral doses of AZD1236 given to healthy young subjects for 13 days and to evaluate the single-dose relative bioavailability of the oral suspension and oral tablet formulations.

Enrollment: 48 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed informed consent prior to any study specific procedures
• Body Mass Index (BMI) between 19-27 kg/m2

Exclusion criteria

• Receipt of another investigational drug in the 4 months before dosing in this study
• Acute illness which requires medical intervention within 2 weeks of Visit 2.
• Abnormal resting BP and pulse rate (after resting for 10 minutes). Supine blood pressure > 140 mmHg systolic or >90 mmHg diastolic, pulse<= 50 or => 90 beats per minute

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 4 patient groups, including a placebo group

Active

Experimental group

Description:

AZD1236 tablet

Treatment:

Drug: AZD1236

Drug: AZD1236

Drug: AZD1236

Placebo

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Drug: Placebo

Relative bioavailability

Other group

Description:

AZD1236 Oral suspension

Treatment:

Drug: AZD1236

Drug: AZD1236

Drug: AZD1236

Relative bioavailability tablet

Other group

Description:

AZD1236 tablet

Treatment:

Drug: AZD1236

Drug: AZD1236

Drug: AZD1236