Study to Investigate Safety, Tolerability and PK Followin... | NCT00818129

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

NCT00818129

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jul 23, 2009Estimated

Enrollment

62Estimated

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

AZD7295
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Not provided

Completion Date

May 2009Actual

First Submitted Date

Dec 24, 2008

First Submission Date that Met QC Criteria

Jan 6, 2009

First Posted Date

Jan 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2009

Last Update Posted Date

Jul 23, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: AZD7295
2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD7295	Drug	ascending single doses (start dose 90 mg), oral solution and then multiple ascending dose (tbd based on single dose results), oral solution	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Masatoshi Tsukamoto, MD	Kyushu Clinical Pharmacolgy Reasearch Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Fukuoka	Fukuoka		Japan