AZD7325 Single Ascending Dose Study in Healthy Male Japanese Subjects (JSAD)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: AZD7325

Study type: Interventional

Funder types: Industry

Identifiers

NCT00769899

D1140C00010

Details and patient eligibility

About

This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose administration to healthy male Japanese volunteers.

Enrollment: 48 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) : 18 to 27 kg/m 2

Exclusion criteria

• Clinically relevant disease and/or abnormalities (past or present)
• Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
• Use of any medication or herbal preparation within 14 days of Study day 1 through the Follow-up Visit other than paracetamol (up to 3 g/day)
• Smoking in excess of 5 cigarettes per day or the equivalent within 28 days prior to the first study day or inability to refrain from smoking during the study confinement period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD7325

2

Placebo Comparator group

Treatment:

Drug: Placebo