A Phase I, Randomized, Double-Blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7295 Following Single and Multiple Ascending Oral Dose Administration in Healthy Male Japanese Subjects

AstraZeneca1 site in 1 country62 target enrollmentDecember 2008

ConditionsHealthy Subjects

InterventionsAZD7295 Placebo

DrugsAZD7295 Placebo

Overview

Phase: Phase 1
Intervention: AZD7295
Conditions: Healthy Subjects
Sponsor: AstraZeneca
Enrollment: 62
Locations: 1
Primary Endpoint: AE, safety laboratory test (haematology, clinical chemistry, urinalysis), 12-lead ECG, BP, pulse rate, body temperature
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

May 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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.

Arms & Interventions

1

Intervention: AZD7295

2

Intervention: Placebo

Outcomes

Primary Outcomes

AE, safety laboratory test (haematology, clinical chemistry, urinalysis), 12-lead ECG, BP, pulse rate, body temperature

Time Frame: During the study

Secondary Outcomes

Pharmacokinetics (Cmax, tmax, AUC, AUC0-t, CL/F, Vss/F, t1/2 , Cmin, Rac, etc)(Frequent sampling until 72 hours after single administration in Single Dose Part and until 72 hours after last administration (6 days administration) in Multiple Dose Part)