AZD9742 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese Subjects

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: AZD9742

Study type: Interventional

Funder types: Industry

Identifiers

NCT01114152

D2690C00003

Details and patient eligibility

About

This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD9742 in healthy male and female Japanese subjects

Enrollment: 35 patients

Sex: All

Ages: 23 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• female (non-childbearing potential)
• Body mass index (BMI) : 17 to 27 kg/m 2

Exclusion criteria

• History of any clinically significant disease or disorder 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
• History or presence of gastrointestinal, hepatic, or renal disease or any otherHistory or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Dose level A, B, C and optional Dose level D and E: single administration and one to three times daily for 6 days (Japanese n=8)

Treatment:

Drug: AZD9742

2

Placebo Comparator group

Description:

placebo given (2 subjects in each dose group)

Treatment:

Drug: Placebo