To Study Safety, Tolerability and Pharmacokinetics of AZD1305 in Healthy Male Japanese Subjects

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD1305; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00738322

D3191C00001

Details and patient eligibility

About

The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body ( how it is taken up into the body, distributed around the body and disappears from the body) in healthy Japanese males.

Enrollment: 36 estimated patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
• Japanese males

Exclusion criteria

• ECG findings outside normal reference ranges.
• Potassium outside normal reference ranges.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

36 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD1305

2

Placebo Comparator group

Treatment:

Drug: Placebo