AZD7268 Single Ascending Dose Study in Healthy Japanese Subjects (JSAD)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD7268; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00912353

D1151C00002

Details and patient eligibility

About

This is a Phase I, single center, randomized, double-blind, placebo-controlled single ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268 in healthy Japanese subjects.

Enrollment: 56 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese male and female (of non-child bearing potential) subjects 20 to 45 years of age, inclusive

• Body weight between 50 and 90 kg, inclusive, with a Body Mass Index (BMI)

  • 18 to ≤ 27 kg/m2

Exclusion criteria

• Clinically relevant disease or disorder (past or present), which in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the results or the subject's ability to participate in the study
• Any clinically significant abnormalities in physical examination, vital signs, clinical chemistry, hematology or urinalysis results as judged by the investigator and/or sponsor
• Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

AZD7268

Experimental group

Treatment:

Drug: AZD7268

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo