NCT01244100

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

December 13, 2010

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

October 25, 2010

Last Update Submit

December 10, 2010

Conditions

Healthy

Keywords

Food-effects PK study in healthy subjects.

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

PL2200

EXPERIMENTAL
Drug: PL2200 fastedDrug: PL2200 fed

Interventions

PL2200 fastedDRUG

Fasted state

PL2200
PL2200 fedDRUG

Fed state

PL2200

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houston Institute for Clinical Research

Houston, Texas, 77074, United States

Location

Related Publications (1)

  • Angiolillo DJ, Bhatt DL, Lanza F, Deliargyris EN, Prats J, Fan W, Marathi U. Bioavailability of aspirin in fasted and fed states of a novel pharmaceutical lipid aspirin complex formulation. J Thromb Thrombolysis. 2020 Apr;49(3):337-343. doi: 10.1007/s11239-020-02051-5.

    PMID: 32080811DERIVED

Study Officials

  • Upendra K Marathi, PhD

    PLx Pharma Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 25, 2010

First Posted

November 19, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2010

Last Updated

December 13, 2010

Record last verified: 2010-12

Locations

US(1)