Timed Aspirin Chronobiome Study

NCT03590821 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 829532
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether timed administration of aspirin ameliorates the effects of celecoxib on blood pressure.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Blood pressure [mmHg]

  Ambulatory blood pressure measurements

  24-48 hours

Secondary Outcomes (1)

• Mean arterial pressure (MAP)

  24-48 hours

Study Arms (2)

Aspirin 81 mg/Placebo

EXPERIMENTAL

Participants will receive aspirin in Phase 1 followed by matched placebo in Phase 2, or vice versa, over 14 days. The order will be randomized and aspirin/placebo will be double-blinded.

Drug: Aspirin 81 mg; Drug: Celecoxib 200mg capsule

Celecoxib 200mg capsule

EXPERIMENTAL

Participants will receive celecoxib in Phase 1 and Phase 2 over 7 days. This is open, meaning participant and investigator will recognize celecoxib capsules.

Drug: Aspirin 81 mg; Drug: Celecoxib 200mg capsule

Interventions

Aspirin 81 mg DRUG

timed administration of aspirin in the evening

Aspirin 81 mg/Placebo; Celecoxib 200mg capsule

Celecoxib 200mg capsule DRUG

daily administration of celecoxib

Aspirin 81 mg/Placebo; Celecoxib 200mg capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women greater than 18 years of age
• Subjects must be in good health based on medical history, physical examination, vital signs, and laboratory tests. In order to ensure sufficient enrollment of subjects in the higher age groups, volunteers with the following conditions may participate in the study:
• Adequately controlled hypertension, with diastolic blood pressure ≤100 mmHg at screening.
• Total cholesterol of ≤270 mg/dL
• Body mass index (BMI) between 18 and 30 kg/m2.
• Has not used tobacco products, including smoking cessation nicotine-containing products (e.g., nicotine patch, nicotine gum), for at least the 3 months prior to screening.
• Female subjects of child bearing potential must be using a medically acceptable method of contraception (oral contraception, Depo-Provera injection, IUD, condom with spermicide, diaphragm, cervical cap, progestin implant, abstinence, tubal ligation, oophorectomy, TAH) throughout the entire study period. All female subjects must consent to a serum and urine pregnancy test at screening and close-out and a urine pregnancy test just prior to the start of each treatment phase of the study, which must be negative at all time points.
• All subjects must consent to a urine drug and nicotine test at screening. Results must be negative. A positive result will be reported to the subject.
• Does not consume more than 1 alcoholic beverage per day on average.
• Able and willing to refrain from alcohol use within 48 hours prior to the first dose of study drug and during the study period until the final study visit.
• Able to understand and comply with study procedures.
• Able and willing to provide written informed consent prior to any study procedures being performed.

You may not qualify if:

• Female subjects who are pregnant or nursing a child.
• Subjects who have received an investigational drug or used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening.
• Subjects with any coagulation, bleeding or blood disorders.
• Subjects who are sensitive or allergic to celecoxib (Celebrex) or aspirin or their components.
• Subjects who are sensitive or allergic to aspirin or other NSAIDs.
• Subjects with documented history of any gastrointestinal disorders, including bleeding ulcers.
• History of significant cardiovascular disease (including stroke or TIA), renal, hepatic, respiratory (except infections which longer \> 6 months prior to screening), immune, endocrine, hematopoietic disorder or neurological disorders.
• History of cancer within the last 5 years (except for cutaneous basal cell or squamous cell cancer resolved by excision, or carcinoma in situ of the cervix adequately treated).
• Has taken the following NSAID or antisecretory agents within 2 weeks prior to study drug administration:
• Nonsteroidal anti-inflammatory drugs (NSAIDs) including acetaminophen or other medications for pain, including aspirin or aspirin-containing products
• Proton pump inhibitors, including Prilosec®, Prevacid®, Aciphex®, Protonix®, or Nexium® (antacid medications, including OTC products, are not permitted within 24 hours of dosing)
• H2 blockers, including Tagamet®, Zantac®, Axid®, or Pepcid®
• Has ever taken the following anti-platelet or anti-coagulant agents:
• Any anti-platelet agent, including Aggrenox®, Brilinta®, Plavix®, Ticlid®, Pletal®, ReoPro®, Integrilin®, Aggrastat®, Persantine®, or Effient®
• Any anti-coagulant including Arixtra®, Coumadin®, acenocoumarol, Lovenox®, phenprocoumon, phenindione, heparin, Exanta®, Pradaxa®, argatroban, lepirudin, hirudin, bivalirudin, or Xarelto®

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Skarke C, Lahens NF, Rhoades SD, Campbell A, Bittinger K, Bailey A, Hoffmann C, Olson RS, Chen L, Yang G, Price TS, Moore JH, Bushman FD, Greene CS, Grant GR, Weljie AM, FitzGerald GA. A Pilot Characterization of the Human Chronobiome. Sci Rep. 2017 Dec 7;7(1):17141. doi: 10.1038/s41598-017-17362-6.

  PMID: 29215023 BACKGROUND

MeSH Terms

Interventions

Aspirin; Celecoxib

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzenesulfonamides; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Carsten Skarke, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LaVenia Banas, CRN

CONTACT

215-573-1862; banas@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Administration of acetylsalicylic acid versus placebo will be masked
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Prospective study design, double-blinded and randomized by order for acetylsalicylic acid versus placebo, open for celecoxib. In a prospective study each individual will undergo two treatment periods randomized by order (separated by 3 weeks of washout). In one period, placebo (matching aspirin for double-blinding) will be administered in the evening for 14 days. In the other period, aspirin (81 mg QD) will be administered in the evening for 14 days. Drug intake will be timed to occur within 1-2 hours prior to falling asleep. Celecoxib (200 mg BID) will be added openly for the final 7 days during each treatment period.

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: July 18, 2018
• Study Start (Estimated): December 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)