AZD7325 Single Ascending Dose Study in Healthy Male Japanese Subjects

AstraZeneca48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteer

Interventions

AZD7325DRUG

Capsule for oral, single dose

PlaceboDRUG

Placebo capsule for oral, single dose

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Glendale, California, United States

Research Site

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Safety and tolerabilityThe nature and incidence of adverse events (AEs), vital signs,physical examinations,electrocardiograms (ECGs)and laboratory assessments.

Time frame: During the study

Secondary Outcomes

Pharmacokinetic parameters for AZD7325

Time frame: During residential period

Genetic analysis of the genes involved in the pharmacokinetics and safety and tolerability to AZD7325 treatment may be performed. Participation in the exploratory genetic study is optional for the subjects.

Time frame: During the study

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.