Clinical trial NCT02711579: Impact of Celecoxib on Electrophysiological Property in Brain of Healthy Volunteer
Official title: Impact of Selective Cyclooxygenase-2 Inhibitor, Celecoxib on Cortical Excitability and Electrophysiological Property in Brain of Healthy Volunteer: Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Electrophysiologic Property of Brain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: the purposes of this study are to evaluate the acute electrophysiological response in brain cortex to single oral dose of celecoxib (400mg once) in healthy volunteer and the electrophysiological alteration in brain cortex by long-term treatment of celecoxib (200mg twice-daily for 7 days) in healthy volunteer

Detailed description: Inflammatory response is considered as defense mechanism against physical or infectious insults and also prevails within the central nervous system. Following certain kinds of brain injuries (i.e trauma, ischemia, hypoxia and seizure), innate immunity and subsequent adaptive immunity subserve the robust inflammatory cascades, leading to excitatory synaptic networks. Cellular elements, such as neuron, microglia as well as inflammatory molecules (cyclooxygenase2, interleukin-1, tumor necrosis factor-alpha, etc) play essential roles in enhancing this process.

In line with these, compelling evidences in animal studies in epilepsy field indicate that celecoxib (COX-2 inhibitor) has anticonvulsant actions, although its mechanisms are not fully understood. Thus, oral administration of Celecoxib in human has a high potential to suppress the neuronal excitability. As a milestone for the big picture, current study is going to prove the changes of cortical excitability evoked by transmagnetic stimulation (TMS) and electroencephalographic properties revealed by EEG in healthy volunteer, given that power spectral analysis of EEG and several parameters of TMS , can detect the small changes of neuronal activities by celecoxib.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female aged between 20 and 50 years.
* Signed voluntary written informed consent.
* Body mass index between 16.0 and 30.0 kg/m2.

Exclusion Criteria:

* History of cardiovascular disease (i.e. Heart disease, Stroke), hepatic disease, inflammatory bowel disease, gastrointestinal hemorrhage, or seizure(s).
* History of hypersensitivity to any medication(s) (i.e. urticaria, angioedema, shock)
* History of any kind of medication(s) within 1 week before screening.
* Presence of clinically significant electrocardiogram abnormality at screening.
* aspartate transaminase or alanine transaminase : greater than 2.0 × upper normal limit.
* Serum creatinine levels : greater than 1.5 × upper normal limit.
* Platelet counts lower than 100,000 / μL
* Serum potassium : greater than 5.5 mmol/L
* Female who is pregnant, breastfeeding, or intends to become pregnant.
* History of noncompliance with medications.
* History of alcohol abuse.
* Participation in drug study within 30 days before screening.
* Galactose intolerance

Primary outcomes:
measure: Power spectral change by single oral dose of celecoxib (400mg once) in healthy volunteer
timeFrame: 4 hours after medical treatment
measure: Cortical excitability alteration in brain cortex by long-term treatment of celecoxib (200mg twice-daily for 7 days) in healthy volunteer
timeFrame: 7 days after medical treatment
Secondary outcomes:
measure: Power spectral change by celecoxib in different locations and different frequency band.
timeFrame: 4 hours and 7 days after medical treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Il Park, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References: