A Study to Evaluate Safety and Tolerability After Oral Dosing of AZD1656 in Healthy Volunteers

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD1656

Study type: Interventional

Funder types: Industry

Identifiers

NCT00726427

D1020C00001

Details and patient eligibility

About

The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in healthy male subjects

Enrollment: 32 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of informed consent
• Clinically normal physical findings and laboratory values as judged by the investigator including negative test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to hepatitis C virus.

Exclusion criteria

• Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the Investigational Product
• History of psychiatric or somatic disease/condition that may interfere with the objectives of the study, as judged by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

32 participants in 2 patient groups

1

Experimental group

Description:

8 increasing oral single doses given to 8 groups (3 on active and 1 on placebo in each group)

Treatment:

Drug: AZD1656

Drug: AZD1656

2

Experimental group

Description:

2 oral doses of AZD1656 given to 2 groups together with food

Treatment:

Drug: AZD1656

Drug: AZD1656