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NCT06361212CompletedPhase 1

Ethoximod Pharmacokinetics In Healthy Subjects

A Single-center, Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Ethoximod in Healthy Subjects.

Source: ClinicalTrials.gov · Last updated 11 Apr 2024

Brief summary (registry, in English)

The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Ethoximod in healthy subjects. The main questions it arms to answer are: 1. to evaluate the safety and tolerance of Ethoximod in healthy subjects after single or repeated doses. 2. to assess the pharmacokinetics and pharmacodynamics of Ethoximod in healthy subjects after single or repeated doses. 3. to evaluate of the effect of food on the pharmacokinetics of Ethoximod in healthy subjects Participants will receive test tablets or placebo at the indicated date and collect blood samples.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
65 (actual)
First submitted
12 Mar 2024
Start date
1 Sept 2022
Primary completion date
20 Sept 2022
Lead sponsor
Longevity Inc.
Diseases
Psoriasis
NCT number
NCT06361212

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 65
  • From 1 Sept 2022 to the primary completion date, 20 Sept 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Those who smoked more than 5 cigarettes per day in the 3 months before the test.
  • Blood donation or significant blood loss (\>450 mL) within three months before screening.
  • Taking any drugs that alter liver enzyme activity 28 days before screening.
  • Take any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines within 14 days before screening.
  • Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.) or engaged in strenuous exercise within 2 weeks before screening, or other factors that affect drug absorption, distribution, metabolism, excretion, etc.
  • Participated in a drug clinical trial within three months before taking the study drug.
  • Acute illness or concomitant medication occurs from the screening stage to study medication.
  • Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours before taking study drug.
  • Positive alcohol breath test 24 hours before taking study medication or upon check-in.

Other illness

  • Have a history of allergy to the trial drug or its excipients, or allergic constitution (allergy to multiple drugs and food).
  • Have a history of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine).
  • Have a history of dysphagia or any gastrointestinal disease that affects drug absorption.
  • Suffering from any disease that increases the risk of bleeding, such as acute gastritis or gastric and duodenal ulcers.
  • Those with a history of herpes zoster or chickenpox.
  • Positive screening results for viral hepatitis (including hepatitis B and hepatitis C), HIV antibodies, and Treponema pallidum antibodies.
  • Those with a positive urine drug screen or a history of drug abuse within the past five years or 3 years before the test.

Lab values

  • ECG abnormalities have clinical significance or QTC\>470ms in men or QTC\>480ms in women.
  • Female subjects are lactating or have positive serum pregnancy results during the screening period or during the trial.
  • Clinically significant abnormalities in clinical laboratory tests or other clinically significant following diseases diagnosed within 12 months (including but not limited to gastrointestinal, renal, liver, neurological, blood, endocrine, tumor, lung, immune, psychiatric or Cardiovascular disease).

Other

  • Recent significant changes in eating or exercise habits.

Who the study is looking for

  • Before the test, sign an informed consent form and fully understand the written test content, process and possible adverse reactions.
  • Complete research in accordance with the requirements of the trial plan.
  • Subjects (including partners) are willing to have no pregnancy plans in the next 6 months and voluntarily take effective contraceptive measures.
  • Male and female subjects aged 18 to 50 years old (including 18 and 50 years old).
  • Male subjects must weigh no less than 50 kg, and female subjects must weigh no less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), body mass index is in the range of 18\~28kg/m2 (including the critical value).
  • Health status: No clinically significant history of heart, liver, kidney, digestive tract, nervous system, respiratory system (such as asthma, exercise-induced asthma, chronic obstructive pulmonary disease), mental disorder, metabolic abnormality, etc.
  • Normal physical examination and vital signs or abnormal without clinical significance.

Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Hospital of Jilin University
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.