Investigate the Safety Tolerability and Pharmacokinetics of Multiple Doses of AZD1236

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00767052
• Other study ID #: D4260C00006
• Status: Completed
• Phase: Phase 1
• First received: October 3, 2008
• Last updated: June 29, 2009
• Start date: September 2008
• Est. completion date: December 2008

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• AZD1236
75mg once daily or 75mg twice daily will be administered in multiple dose part.
• Placebo
Placebo tablet matching to the active in multiple dose part.
• AZD1236
75mg single dose will be administered in relative bioavailability part.
• AZD1236
75mg oral suspension single dose will be administered in relative bioavailability part.

Locations

Country	Name	City	State
Japan	Research Site	Osaka-city	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	No