Multiple Ascending Dose Study for AZD 7268 in Japanese He... | NCT01116011

Studies
Multiple Ascending Dose Study for AZD 7268 in Japanese Healthy Male Volunteers

NCT01116011

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 15, 2010Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

AZD7268
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

Nov 2010

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

Apr 2010

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Apr 13, 2010

First Submission Date that Met QC Criteria

May 3, 2010

First Posted Date

May 4, 2010Estimated

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

Dec 14, 2010

Last Update Posted Date

Dec 15, 2010Estimated

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

This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered AZD7268 after multiple ascending doses.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AZD7268	Experimental		Drug: AZD7268
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD7268	Drug	Capsule, Oral, BID	AZD7268
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Investigate the safety and tolerability of AZD7268 by Adverse Events.		From first dosing throughout the treatment period and including the follow-up period

Secondary Outcomes

Measure	Description	Time Frame
Characterize the PK parameters(Cmax, AUC,t1/2) of AZD7268 by assessment of drug concentrations in plasma		Blood samples will be taken from pre-dose until 48 hours post last dose
Characterize the PK parameters (CLr, Ae) of AZD7268 by assessment of drug concentrations in urine

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of Informed Consent
Healthy male subjects, with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

Inability to understand or cooperate with given information
Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, Hepatitis C and syphilis test
History of seizure (including infant febrile seizures) or family history of seizure

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tomoe Fujita	Kitasato University East Hospital, Kanagawa, Japan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Kanagawa	Sagamihara		Japan