Comparative Bioavailability in Healthy Elderly Volunteers | NCT01253122

Studies
Comparative Bioavailability in Healthy Elderly Volunteers

NCT01253122

Sponsor

TauRx Therapeutics Ltd

Status

Completed

Last Update Posted

Dec 3, 2010Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Alzheimer's Disease

Interventions

TRx0037

Countries

Not provided

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

Dec 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

Feb 2010

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Dec 2, 2010

First Submission Date that Met QC Criteria

Dec 2, 2010

First Posted Date

Dec 3, 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 2, 2010

Last Update Posted Date

Dec 3, 2010Estimated

Name	Class
Quotient Clinical	OTHER

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

A randomised four way crossover design in which each subject will receive two dose levels of TRx-0037 and two doses of TRx-0014 over approximately a four week period in randomised order.

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

24Actual

Label	Type	Description	Intervention Names
TRx0037	Experimental		Drug: TRx0037
TRx0014	Active Comparator		Drug: TRx0037

Name	Type	Description	Arm Group Labels	Other Names
TRx0037	Drug		TRx0014 TRx0037

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relative bioavailability	Investigate the relative bioavailability of TRx0037 and TRx0014 at two molar equivalent doses in healthy elderly male and female (post-menopausal/non-childbearing) subjects

Secondary Outcomes

Measure	Description	Time Frame
Safety, tolerability and pharmacokinetics	Safety, tolerability and pharmacokinetic (PK) evaluations of the two dose levels of TRx0037 and TRx0014.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female 55 and over
No clinically important abnormal physical finding
No clinically significant lab results
Normal ECG, Normal BP and HR,BMI between 19 and 32
Weight 50 to 100 kg, Able to communicate
Provide written informed consent
Non smokers
Males to use contraception
Females to be surgically sterile or post menopausal

Exclusion Criteria:

Administration of any IMP other than study drug within 12 weeks before entry
Use of any prescribed meds, St John's wort, over the counter meds as described in the protocol
Surgical or medical condition that might interfere with IMP
History of drug or alcohol abuse
Clinically significant allergy requiring treatment
Loss of greater than 400ml of blood within 12 weeks.
Serious adverse reaction or hypersensitivity to any drug
Prescence of Hep B, Hep c or HIV-1 or HIV-2 at screening
Presence of G6PD at screening
History of methaemoglobinaemia
Partner who is pregnant of lactating
Positive Pregnancy test

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Stuart Dr Mair, MBChB	Quotient Clinical	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided