Trial Outcomes & Findings for Lipidomics Screening of Celecoxib in ex Vivo Human Whole Blood Assay - Part B (NCT NCT02413203)

NCT ID: NCT02413203

Last Updated: 2017-05-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

A single visit of around 4 hours

Results posted on

2017-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Celecoxib 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.	Placebo Oral administration of a single placebo pill. Placebo: Blood and urine collections before and 3 hours after placebo administration.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Celecoxib n=10 Participants 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.	Placebo n=10 Participants Oral administration of a single placebo pill. Placebo: Blood and urine collections before and 3 hours after placebo administration.	Total n=20 Participants Total of all reporting groups
Age, Continuous	32.2 years STANDARD_DEVIATION 8.6 • n=99 Participants	30 years STANDARD_DEVIATION 9 • n=107 Participants	32.1 years STANDARD_DEVIATION 8.6 • n=206 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	7 Participants n=107 Participants	13 Participants n=206 Participants

PRIMARY outcome

Timeframe: A single visit of around 4 hours

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.

Outcome measures

Outcome measures
Measure	Celecoxib n=10 Participants 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.	Placebo n=10 Participants Oral administration of a single placebo pill. Placebo: Blood and urine collections before and 3 hours after placebo administration.
Quantification of Plasma Lipids in the Whole Blood: Prostaglandin E2 (PGE2)	49.9 percentage of pre-dose control Standard Deviation 26.59	110 percentage of pre-dose control Standard Deviation 49.2

PRIMARY outcome

Timeframe: A single visit of around 4 hours

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.

Outcome measures

Outcome measures
Measure	Celecoxib n=10 Participants 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.	Placebo n=10 Participants Oral administration of a single placebo pill. Placebo: Blood and urine collections before and 3 hours after placebo administration.
Quantification of Plasma Lipids in the Whole Blood: Prostaglandin F2a (PGF2a)	45.48 percentage of pre-dose control Standard Deviation 20.51	97.2 percentage of pre-dose control Standard Deviation 32.9

PRIMARY outcome

Timeframe: A single visit of around 4 hours

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.

Outcome measures

Outcome measures
Measure	Celecoxib n=10 Participants 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.	Placebo n=10 Participants Oral administration of a single placebo pill. Placebo: Blood and urine collections before and 3 hours after placebo administration.
Quantification of Plasma Lipids in the Whole Blood: Thromboxane B2 (TxB2)	52.2 percentage of pre-dose control Standard Deviation 16.9	83.4 percentage of pre-dose control Standard Deviation 12.8

PRIMARY outcome

Timeframe: A single visit of around 4 hours

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.

Outcome measures

Outcome measures
Measure	Celecoxib n=10 Participants 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.	Placebo n=10 Participants Oral administration of a single placebo pill. Placebo: Blood and urine collections before and 3 hours after placebo administration.
Quantification of Plasma Lipids in the Whole Blood: 15-Hydroxyeicosatetraenoic Acid (15-HETE)	49 percentage of pre-dose control Standard Deviation 18.7	81.65 percentage of pre-dose control Standard Deviation 22.8

SECONDARY outcome

Timeframe: A single visit of around 4 hours

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.

Outcome measures

Outcome measures
Measure	Celecoxib n=10 Participants 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.	Placebo n=10 Participants Oral administration of a single placebo pill. Placebo: Blood and urine collections before and 3 hours after placebo administration.
Urinary Lipid Metabolites: PGE2 Metabolite (PGE-M)	79.15 percentage of pre-dose control Standard Deviation 24.19	106 percentage of pre-dose control Standard Deviation 20.1

SECONDARY outcome

Timeframe: A single visit of around 4 hours

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.

Outcome measures

Outcome measures
Measure	Celecoxib n=10 Participants 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.	Placebo n=10 Participants Oral administration of a single placebo pill. Placebo: Blood and urine collections before and 3 hours after placebo administration.
Celecoxib Plasma Concentration	352.6 ng/ml Standard Deviation 221	0 ng/ml Standard Deviation 0

SECONDARY outcome

Timeframe: A single visit of around 4 hours

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.

Outcome measures

Outcome measures
Measure	Celecoxib n=10 Participants 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.	Placebo n=10 Participants Oral administration of a single placebo pill. Placebo: Blood and urine collections before and 3 hours after placebo administration.
Urinary Lipid Metabolites: PGI2 Metabolite (PGI-M)	41.47 percentage of pre-dose control Standard Deviation 11	78.6 percentage of pre-dose control Standard Deviation 52.23

SECONDARY outcome

Timeframe: A single visit of around 4 hours

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.

Outcome measures

Outcome measures
Measure	Celecoxib n=10 Participants 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.	Placebo n=10 Participants Oral administration of a single placebo pill. Placebo: Blood and urine collections before and 3 hours after placebo administration.
Urinary Lipid Metabolites: TxB2 Metabolite (Tx-M)	79 percentage of pre-dose control Standard Deviation 14.4	77.9 percentage of pre-dose control Standard Deviation 17.2

Adverse Events

Celecoxib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Garret A. FitzGerald

Univesrity of Pennsylvania

Phone: 215-898-1185

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place