Food-Effect Pharmacokinetic Study of PL2200

This study has been completed.
Sponsor:
Information provided by:
PLx Pharma
ClinicalTrials.gov Identifier:
NCT01244100
First received: October 25, 2010
Last updated: December 10, 2010
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Healthy
Drug: PL2200 fasted
Drug: PL2200 fed
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)

Further study details as provided by PLx Pharma:

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. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PL2200 Drug: PL2200 fasted
Fasted state
Drug: PL2200 fed
Fed state

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244100

Locations
United States, Texas
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.
  More Information

No publications provided

Responsible Party: Jason Moore, Vice President, PLx Pharma Inc.
ClinicalTrials.gov Identifier: NCT01244100     History of Changes
Other Study ID Numbers: PL-ASA-003
Study First Received: October 25, 2010
Last Updated: December 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by PLx Pharma:
Food-effects PK study in healthy subjects.

ClinicalTrials.gov processed this record on April 22, 2014