Investigate the Safety Tolerability and Pharmacokinetics of Multiple Doses of AZD1236

AstraZeneca48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Healthy Volunteer

Interventions

AZD1236DRUG

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

PlaceboDRUG

Placebo tablet matching to the active in multiple dose part.

AZD1236DRUG

75mg single dose will be administered in relative bioavailability part.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Osaka, Osaka, Japan

Outcomes

Primary Outcomes

Safety and tolerability of AZD1236 by assessment of blood pressure, pulse rate, body temperature, laboratory variables, ECG and adverse events

Time frame: 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 Outcomes

Pharmacokinetic profile: concentration of AZD1236 in blood

Time frame: Samples taken during Visit 2 in multiple dosing part at 41 points and Visit 2/3 in relative bioavailability part at 32 points.

Data from ClinicalTrials.gov

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