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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014