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Lipidomics Screening of Celecoxib in ex Vivo Human Whole Blood Assay - Part B

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ClinicalTrials.gov Identifier: NCT02413203
Recruitment Status : Completed
First Posted : April 9, 2015
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Screening
Condition Healthy
Interventions Drug: Celecoxib
Drug: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description

Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.

Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration.

Oral administration of a single placebo pill.

Placebo: Blood and urine collections before and 3 hours after placebo administration.

Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Celecoxib Placebo Total
Hide Arm/Group Description

Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.

Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration.

Oral administration of a single placebo pill.

Placebo: Blood and urine collections before and 3 hours after placebo administration.

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
32.2  (8.6) 30  (9) 32.1  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
4
  40.0%
3
  30.0%
7
  35.0%
Male
6
  60.0%
7
  70.0%
13
  65.0%
1.Primary Outcome
Title Quantification of Plasma Lipids in the Whole Blood: Prostaglandin E2 (PGE2)
Hide Description PGE2 in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma PGE2 was normalized to sample volume (ng/ml) and expressed as a percentage of subject’s pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents PGE2 concentration in ng/ml.
Time Frame A single visit of around 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:

Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.

Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration.

Oral administration of a single placebo pill.

Placebo: Blood and urine collections before and 3 hours after placebo administration.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage of pre-dose control
49.9  (26.59) 110  (49.2)
2.Primary Outcome
Title Quantification of Plasma Lipids in the Whole Blood: Prostaglandin F2a (PGF2a)
Hide Description PGF2a in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma PGF2a was normalized to sample volume (ng/ml) and expressed as a percentage of subject’s pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents PGF2a concentration in ng/ml.
Time Frame A single visit of around 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:

Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.

Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration.

Oral administration of a single placebo pill.

Placebo: Blood and urine collections before and 3 hours after placebo administration.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage of pre-dose control
45.48  (20.51) 97.2  (32.9)
3.Primary Outcome
Title Quantification of Plasma Lipids in the Whole Blood: Thromboxane B2 (TxB2)
Hide Description TxB2 in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma TxB2 was normalized to sample volume (ng/ml) and expressed as a percentage of subject’s pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents TxB2 concentration in ng/ml.
Time Frame A single visit of around 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:

Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.

Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration.

Oral administration of a single placebo pill.

Placebo: Blood and urine collections before and 3 hours after placebo administration.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage of pre-dose control
52.2  (16.9) 83.4  (12.8)
4.Primary Outcome
Title Quantification of Plasma Lipids in the Whole Blood: 15-Hydroxyeicosatetraenoic Acid (15-HETE)
Hide Description 15-HETE in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma 15-HETE was normalized to sample volume (ng/ml) and expressed as a percentage of subject’s pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents 15-HETE concentration in ng/ml.
Time Frame A single visit of around 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:

Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.

Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration.

Oral administration of a single placebo pill.

Placebo: Blood and urine collections before and 3 hours after placebo administration.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage of pre-dose control
49  (18.7) 81.65  (22.8)
5.Secondary Outcome
Title Urinary Lipid Metabolites: PGE2 Metabolite (PGE-M)
Hide Description Effect of celecoxib on systemic PGE2 was assessed by comparing urine PGE-M in celecoxib vs placebo-treated groups. Urine data are reported as a percentage of the volunteer’s own pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents metabolite concentration in ng/mg creatinine.
Time Frame A single visit of around 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:

Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.

Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration.

Oral administration of a single placebo pill.

Placebo: Blood and urine collections before and 3 hours after placebo administration.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage of pre-dose control
79.15  (24.19) 106  (20.1)
6.Secondary Outcome
Title Celecoxib Plasma Concentration
Hide Description Celecoxib plasma concentration will be measured in drug-treated and placebo groups by UPLC-MS/MS, and will be expressed as amount of the drug per volume of plasma (ng/ml). At Tmax of 3 hours after a single oral dose of celecoxib of 200 mg, drug plasma concentration should correspond to the maximum plasma concentration or Cmax.
Time Frame A single visit of around 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:

Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.

Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration.

Oral administration of a single placebo pill.

Placebo: Blood and urine collections before and 3 hours after placebo administration.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ng/ml
352.6  (221) 0  (0)
7.Secondary Outcome
Title Urinary Lipid Metabolites: PGI2 Metabolite (PGI-M)
Hide Description Effect of celecoxib on systemic PGI2 was assessed by comparing urine PGI-M in celecoxib vs placebo-treated groups. Urine data are reported as a percentage of the volunteer’s own pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents metabolite concentration in ng/mg creatinine.
Time Frame A single visit of around 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:

Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.

Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration.

Oral administration of a single placebo pill.

Placebo: Blood and urine collections before and 3 hours after placebo administration.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage of pre-dose control
41.47  (11) 78.6  (52.23)
8.Secondary Outcome
Title Urinary Lipid Metabolites: TxB2 Metabolite (Tx-M)
Hide Description Effect of celecoxib on systemic TxB2 was assessed by comparing urine Tx-M in celecoxib vs placebo-treated groups. Urine data are reported as a percentage of the volunteer’s own pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents metabolite concentration in ng/mg creatinine.
Time Frame A single visit of around 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:

Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.

Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration.

Oral administration of a single placebo pill.

Placebo: Blood and urine collections before and 3 hours after placebo administration.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage of pre-dose control
79  (14.4) 77.9  (17.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description

Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.

Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration.

Oral administration of a single placebo pill.

Placebo: Blood and urine collections before and 3 hours after placebo administration.

All-Cause Mortality
Celecoxib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Celecoxib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Garret A. FitzGerald
Organization: Univesrity of Pennsylvania
Phone: 215-898-1185
EMail: garret@upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02413203     History of Changes
Other Study ID Numbers: 818658-Part B
First Submitted: March 19, 2015
First Posted: April 9, 2015
Results First Submitted: March 6, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017