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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00767052

Enrollment

Registered

2008-10-06

Start date

2008-09-30

Completion date

2008-12-31

Last updated

2009-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer, Safety, Tolerability, Pharmacokinetics, AZD1236

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.

Interventions

DRUGAZD1236

75mg once daily or 75mg twice daily will be administered in multiple dose part.

DRUGPlacebo

Placebo tablet matching to the active in multiple dose part.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026