Investigate the Safety Tolerability and Pharmacokinetics of Multiple Doses of AZD1236

A Randomised Single Centre Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral Multiple Ascending Daily Doses of AZD1236 Tablet by a Single-Blind, Placebo-Controlled, and Single Dose Relative Bioavailability of the Oral Suspension and Oral Tablet Formulations by an Open Cross-Over in Healthy Japanese Men

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: AZD1236; Drug: AZD1236; Drug: AZD1236; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Osaka-city, Osaka, Japan
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo tablet	Drug: Placebo; Placebo tablet matching to the active in multiple dose part.
Experimental: Active; AZD1236 tablet	Drug: AZD1236; 75mg once daily or 75mg twice daily will be administered in multiple dose part.; Drug: AZD1236; 75mg single dose will be administered in relative bioavailability part.; Drug: AZD1236; 75mg oral suspension single dose will be administered in relative bioavailability part.
Other: Relative bioavailability; AZD1236 Oral suspension	Drug: AZD1236; 75mg once daily or 75mg twice daily will be administered in multiple dose part.; Drug: AZD1236; 75mg single dose will be administered in relative bioavailability part.; Drug: AZD1236; 75mg oral suspension single dose will be administered in relative bioavailability part.
Other: Relative bioavailability tablet; AZD1236 tablet	Drug: AZD1236; 75mg once daily or 75mg twice daily will be administered in multiple dose part.; Drug: AZD1236; 75mg single dose will be administered in relative bioavailability part.; Drug: AZD1236; 75mg oral suspension single dose will be administered in relative bioavailability part.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Shunji Matsuki, MD PhD, Kyushu Clinical Pharmacology Research Clinic

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: October 3, 2008
• First Submitted That Met QC Criteria: October 3, 2008
• First Posted (Estimate): October 6, 2008

Study Record Updates

• Last Update Posted (Estimate): June 30, 2009
• Last Update Submitted That Met QC Criteria: June 29, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Safety; Healthy Volunteer; Pharmacokinetics; Tolerability; AZD1236
• Other Study ID Numbers: D4260C00006