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

Oral administration of a single placebo pill.

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.

Celecoxib

Oral administration of a single placebo pill.
Placebo: Blood and urine collections before and 3 hours after placebo administration.

Placebo

Total

Sex: Female, Male

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.

Quantification of Plasma Lipids in the Whole Blood: Prostaglandin E2 (PGE2)

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.

Quantification of Plasma Lipids in the Whole Blood: Prostaglandin F2a (PGF2a)

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.

Quantification of Plasma Lipids in the Whole Blood: Thromboxane B2 (TxB2)

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.

Quantification of Plasma Lipids in the Whole Blood: 15-Hydroxyeicosatetraenoic Acid (15-HETE)

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.

Urinary Lipid Metabolites: PGE2 Metabolite (PGE-M)

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.

Celecoxib Plasma Concentration

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.

Urinary Lipid Metabolites: PGI2 Metabolite (PGI-M)

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.

Urinary Lipid Metabolites: TxB2 Metabolite (Tx-M)

Overall Study

Garret A. FitzGerald

Healthy

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

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

The Clinical Translational Research Center (CTRC) at the Hospital of the University of Pennsylvania

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

A Randomized, Double-blinded, Placebo-controlled Study Investigating the Pharmacological Response to Celecoxib Using ex Vivo Human Whole-blood Assay (hWBA) and Broad-spectrum Lipidomics Analysis

University of Pennsylvania

Eli Lilly and Company

Thirty (n=30) healthy, non-smoking male and female volunteers between the ages of 18-50 will be included in this study. If all inclusion/exclusion criteria are met, a blood collection of 104 ml will be obtained and the study visit will be completed. If eligible, a volunteer may participate in this study up to four separate times, but not more than two times in the same week.

This is a single blood donation, no drugs or devices administered

Blood draw

Lipidomics Screening of Anti-inflammatory Drugs and Drug Candidates in Vitro - Part A

Broad-spectrum Lipidomics Screening of Anti-inflammatory Drugs and Drug Candidates in In Vitro Human Whole-blood Assay (hWBA)

121 volunteers in MRI(+ve) cohort were randomized into two groups to receive either 200mg palm vitamin E (tocotrienols) softgel capsules or a identical looking placebo twice daily. 62 volunteers received 200mg palm vitamin E (tocotrienols) and the remaining 59 received placebo. They were followed up every 3 months for a period of 2 years for their blood biochemistry profile and MRI of the brain was conducted at baseline, 12 months and 24 months..

120 volunteers in MRI(-ve) cohort were randomized into two groups to receive either 200mg palm vitamin E (tocotrienols) softgel capsules or a identical looking placebo twice daily. 63 volunteers received 200mg palm vitamin E (tocotrienols) and the remaining 57 received placebo. They were followed up every 3 months for a period of 1 year for their blood biochemistry profile and MRI of the brain was conducted at baseline and 12 months.

Cerebrovascular Disorders

Individuals randomized in the (MRI+ve) and (MRI -ve) cohort received either 200 mg softgels of Palm Vitamin E (tocotrienols) or placebo taken orally twice a day.

200mg of Palm vitamin E (tocotrienols) or placebo

Kepala Batas Hospital

Neuroprotective and Cardioprotective Effects Of Palm Vitamin E Tocotrienols

A Double Blind Placebo Controlled Study On The Neuroprotective And Anti-Atherogenic Effects Of Palm TocotrienolRich Fraction(Palm Vitamin E)

Yuen Kah Hay

Professor

Universiti Sains Malaysia

Malaysia Palm Oil Board

Acute Coronary Syndrome

veliflapon (DG-031)

Veliflapon (DG-031)to Prevent Heart Attacks or Stroke in Patients With a History of Heart Attack or Unstable Angina

A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Veliflapon (DG-031) in Reducing the Risk of Acute Cardiovascular Events in African American Patients With Coronary Artery Disease(The LTCAD Study).

lipoxygenase/infarkt

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

Lipidomics Screening of Anti-inflammatory Drugs and Drug Candidates in Vitro - Part A

Neuroprotective and Cardioprotective Effects Of Palm Vitamin E Tocotrienols

Veliflapon (DG-031)to Prevent Heart Attacks or Stroke in Patients With a History of Heart Attack or Unstable Angina

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