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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: AZD7295; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Fukuoka-City, Fukuoka, Japan
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2	Drug: Placebo; multiple ascending dose (tbd based on single dose results), oral solution
EXPERIMENTAL: 1	Drug: AZD7295; ascending single doses (start dose 90 mg), oral solution and then multiple ascending dose (tbd based on single dose results), oral solution

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Masatoshi Tsukamoto, MD, Kyushu Clinical Pharmacolgy Reasearch Clinic

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Study Completion (ACTUAL): May 1, 2009

Study Registration Dates

• First Submitted: December 24, 2008
• First Submitted That Met QC Criteria: January 6, 2009
• First Posted (ESTIMATE): January 7, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 23, 2009
• Last Update Submitted That Met QC Criteria: July 22, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Japanese; Phase I; Japan; oral solution
• Other Study ID Numbers: D1820C00001