Study to Investigate Safety, Tolerability and PK Following Single and Multiple Ascending Doses of AZD7295 in Japanese

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: AZD7295; Drug: Placebo

• Registration Number: NCT00818129
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-24
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Study Completion: 2009-05
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-22
• Last Update Posted: 2009-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD7295	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
AE, safety laboratory test (haematology, clinical chemistry, urinalysis), 12-lead ECG, BP, pulse rate, body temperature	During the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Fukuoka-City, Fukuoka, Japan