Food-Effect Pharmacokinetic Study of PL2200

Sponsor

PLx Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01244100

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

This trial is a food-effect study to assess fasted versus fed pharmacokinetics of PL2200.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PL2200 fasted Drug: PL2200 fed	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PL2200	Drug: PL2200 fasted Fasted state Drug: PL2200 fed Fed state

Arm

Intervention/Treatment

Experimental: PL2200

Drug: PL2200 fasted

Fasted state

Drug: PL2200 fed

Fed state

Outcome Measures

Primary Outcome Measures

Effect of food by ratio of least-squares means (LSM) of the pharmacokinetic (PK) parameter of AUC0-t of the primary metabolite, salicylic acid, in the fed state versus the fasted state. [24 hours]
Effect of food by ratio of least-squares means (LSM) of the PK parameter of AUC0-inf of the primary metabolite, salicylic acid, in the fed state versus the fasted state. [24 hours]
Effect of food by ratio of least-squares means (LSM) of the PK parameter of Cmax of the primary metabolite, salicylic acid, in the fed state versus the fasted state. [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy normal male and female volunteers between 21 and 65 years of age.

Exclusion Criteria:

Abnormal findings on physical examination or clinical laboratories, or significant medical history.
Subject with hypersensitivity or contraindications to aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drug (NSAID).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Houston Institute for Clinical Research	Houston	Texas	United States	77074

Sponsors and Collaborators

PLx Pharma

Investigators

Study Director: Upendra K Marathi, PhD, PLx Pharma Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01244100

Other Study ID Numbers:

PL-ASA-003

First Posted:

Nov 19, 2010

Last Update Posted:

Dec 13, 2010

Last Verified:

Dec 1, 2010

Keywords provided by , ,

Food-effects PK study in healthy subjects.

Additional relevant MeSH terms:

Aspirin

Study Results

No Results Posted as of Dec 13, 2010