Study to Investigate Single Ascending Oral Doses of AZD52... | NCT01121302

Studies
Study to Investigate Single Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects

NCT01121302

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jan 28, 2015Estimated

Enrollment

88Actual

Phase

Phase 1

Conditions

Tolerability

Interventions

AZD5213
Placebo

Countries

United States

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

Official Title

A Phase I Study of Orally-administered AZD5213 in Healthy Males and Non-fertile Females Including Randomized, Double-blind, Placebo-controlled, Parallel-group Assessment of the Safety, Tolerability & PK of Single Ascending Dose (Part 1) & an Open-label Assessment of Effect of Food on the PK (Part 2)

Status Module

Record Verification Date

Jan 2015

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

May 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

May 10, 2010

First Submission Date that Met QC Criteria

May 11, 2010

First Posted Date

May 12, 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

Jan 27, 2015

Last Update Posted Date

Jan 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 main purpose of this study is to assess the safety and tolerability of AZD5213 after single oral doses.
Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves your body and how your body acts on the study drug) of AZD5213 in your blood and urine.

One group of subjects will be studied to see how food affects the pharmacokinetics (PK) of AZD5213 in the blood and urine. They will receive AZD5213 once after fasting overnight and then return to the clinic to receive AZD5213 after eating a high fat breakfast.

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

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	dose escalating	Drug: AZD5213
2	Placebo Comparator	placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD5213	Drug	0.1 mg, 0.3 mg, 1 mg, 2 mg, 4 mg, 8 mg, 16 mg, 32 mg oral solution, single ascending doses	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events, vital signs, physical (including neurological) examinations, clinical laboratory variables, electrocardiograms, telemetry, sleep diary (temporal and qualitative aspects), and the Columbia-Suicide Severity Rating Scale		AE will be collected from admission on Day -1 until follow-up

Secondary Outcomes

Measure	Description	Time Frame
Part 1 : Investigate single-dose PK and dose proportionality of orally-administered AZD5213		Frequent timepoints within 48 hours of single dose administration
Part 2 Investigate the potential effect of food on AZD5213 PK after administration of AZD5213 as an oral solution

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suitable veins for cannulation or repeated venipuncture.
Male healthy volunteers should be willing to use barrier contraception during sexual intercourse, ie condoms, even if partner is using contraceptive method, from the first day of dosing until 3 months after the last dosing with AZD5213.
Body weight of ≥50 to ≤100 Kg and Body Mass Index (BMI) ≥18 to ≤30 kg/m2.

Exclusion Criteria:

History and presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastorintestinal and psychiatric/mental disorders.
History or presence of gastrointestinal (including irritable bowel disease), hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. Surgery on gastrointestinal tract.
History of previous or ongoing psychiatric disorders.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Mathews, MD	Quintiles, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Overland Park	Kansas		United States