Study to Assess the Pharmacokinetics of AZD6140 After Single Dose in Healthy Japanese Male Volunteers

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD6140

Study type: Interventional

Funder types: Industry

Identifiers

NCT01588626

D5133C00001

Details and patient eligibility

About

The purpose of this study is to assess the pharmacokinetics of AZD6140 and its active metabolite, safety, tolerability of AZD6140 following single administration in healthy male Japanese volunteers.

Full description

A Phase I, Single Centre, Open Study to Assess the Pharmacokinetics of oral AZD6140 after Single Dose in Healthy Japanese Male Volunteers

Enrollment: 12 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subject aged between 20 to 45 years inclusive
• Body mass index (BMI=weight/height2) between 18.0 to 27.0 kg/m2 inclusive
• Body weight between 50.0 to 85.0 kg inclusive Provision of written informed consent

Exclusion criteria

• Clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator, or positive results on screening tests for serum hepatitis B surface antigen and hepatitis C antibody, syphilis and human immu
• Supine blood pressure > 150 mmHg systolic or > 95 mmHg diastolic or supine pulse > 90 beats per minute (after resting for 10 minutes) Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms
• Personal or familial predisposition for thrombotic disorders Clinically significant medical history, including psychiatric disorders and severe allergies

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

AZD6140

Experimental group

Description:

single administration of 90 mg dose of AZD6140

Treatment:

Drug: AZD6140