Investigate the Safety Tolerability and Pharmacokinetics of Multiple Doses of AZD1236

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: AZD1236; Drug: Placebo

• Registration Number: NCT00767052
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Study First Posted: 2008-10-06
• Study Completion: 2008-12
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-29
• Last Update Posted: 2009-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	AZD1236	AZD1236 tablet
Placebo	Placebo	Placebo tablet
Relative bioavailability	AZD1236	AZD1236 Oral suspension
Relative bioavailability tablet	AZD1236	AZD1236 tablet

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of AZD1236 by assessment of blood pressure, pulse rate, body temperature, laboratory variables, ECG and adverse events	Assessments taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow up visit. Volunteers will be monitored throughout the study for adverse events.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile: concentration of AZD1236 in blood	Samples taken during Visit 2 in multiple dosing part at 41 points and Visit 2/3 in relative bioavailability part at 32 points.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Osaka-city, Osaka, Japan