Assessment of PCSO-524 Relative to a Comparator Product | NCT01564160

Studies
Assessment of PCSO-524 Relative to a Comparator Product

NCT01564160

Sponsor

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Status

Completed

Last Update Posted

Dec 3, 2012Estimated

Enrollment

10Estimated

Phase

Early Phase 1

Conditions

Healthy

Interventions

Fish Oil
PCSO-524

Countries

Canada

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

ID	Type	Description	Link
176412	Other Identifier	Health Canada
12-02-003	Other Identifier	Canadian SHIELD Ethics Review Board

Status Module

Record Verification Date

Nov 2012

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 2012

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Mar 22, 2012

First Submission Date that Met QC Criteria

Mar 23, 2012

First Posted Date

Mar 27, 2012Estimated

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

Nov 30, 2012

Last Update Posted Date

Dec 3, 2012Estimated

Name	Class
Pharmalink International Ltd.	UNKNOWN

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 marine lipid oil extract isolated from the New Zealand Greenshell® Mussel, Perna canaliculus (P. canaliculus), contains a unique synergistic blend of marine fatty acids.

The objective of the this study is to evaluate the acute (5-hour) and chronic (21-day) bioavailability of a fixed dose of PCSO-524 compared to a fish oil product in a population of healthy adult participants.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: PCSO-524	Experimental	PCSO-524	Dietary Supplement: PCSO-524
Arm 2: Fish Oil	Active Comparator	Fish Oil	Dietary Supplement: Fish Oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fish Oil	Dietary Supplement	Source of omega-3 fatty acids.	Arm 2: Fish Oil

Measure	Description	Time Frame
Serum Phospholipid		Day 0 and Day 21

Measure	Description	Time Frame
Total Serum Lipid		Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose
Serum Free Fatty Acid		Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The individual is fluent in English and understands the study requirements
The participant is willing and able to comply with all requirements defined within this protocol.
The individual is willing to provide written informed consent
The individual is male or female
The individual is between 18 and 65 years of age
The individual's blood EPA+DPA+DHA ≤ 5.2% at screening

Exclusion Criteria:

The individual is unable to or refuses to provide written informed consent
The individual has taken omega-3 supplements within 3 months of screening.
Supplements containing any of the following sources of omega-3s will exclude the individual from the study: fish oil, flax oil, krill oil, green-lipped mussel, chia, perilla, algea
The individual's blood EPA+DPA+DHA ≥ 5.2% at screening
The individual is female and pregnant or breastfeeding, or plans to be during the trial period
The individual has known allergies product ingredients (fish/seafood)
The individual has any significant medical illness or condition
The individual has reported a history of drug dependence or substance abuse (excluding nicotine)
The individual is taking lipid-altering medications (statins, niacin, carnitine, fibrates etc.)
The individual is unable to abstain from caffeine, alcohol or physical activity for 24 hours before each treatment visit
The individual will be excluded if he or she has any additional conditions that, in the Investigator's opinion, would preclude the participant from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005395	Fish Oils
C000631483	PCSO-524

ID	Term
D009821	Oils
D008055	Lipids