Study to Investigate Safety, Tolerability and PK Following Single and Multiple Ascending Doses of AZD7295 in Japanese

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: AZD7295

Study type: Interventional

Funder types: Industry

Identifiers

NCT00818129

D1820C00001

Details and patient eligibility

About

The primary objective of this study is to investigate the safety and tolerability of single and multiple oral doses of AZD7295 in healthy male Japanese subjects. This will be done by comparing the effect of AZD7295 to placebo. The study will aslo investigate the absorption, distribution and disappearance of AZD7295 in the body.

Enrollment: 62 estimated patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed, written and dated informed consent
• Healthy male Japanese volunteers aged 20-55 years
• BMI between 18 and 27 kg/m2
• Have negative screens for HIV, hepatitis B and C viruses and syphilis

Exclusion criteria

• Use of prescribed medication within 2 weeks prior to the dose of study medication
• Participation in another study that included drug treatment within 16 weeks before the start of the present study.
• History or presence of gastrointestinal, hepatic or renal disease or a condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
• History of severe food or drug allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged relevant by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD7295

2

Placebo Comparator group

Treatment:

Drug: Placebo