Pharmacokinetics and Safety of Single Oral Etrasimod Arginine in Healthy Adults for Ulcerative Colitis Using At-Home Tasso Sampling and Wearable Monitoring

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What is this study about?

The medication being studied is Etrasimod tablets, an oral drug taken at a dose of 2 mg. It is being investigated for its potential use in several immune-mediated inflammatory disorders, which are conditions where the immune system mistakenly attacks the body’s own tissues. Examples of these disorders include ulcerative colitis (a chronic inflammation of the colon), alopecia areata (patchy hair loss), atopic dermatitis (a type of eczema), and eosinophilic esophagitis (inflammation of the esophagus caused by certain white blood cells).

The purpose of the study is to compare how the medication is absorbed and processed in the body (known as PK, or pharmacokinetics) when blood samples are collected by the participant using a small fingertip device called a Tasso device versus when samples are taken by study staff. Healthy adult volunteers receive a single dose of the tablet, then use the Tasso device at home to collect tiny blood spots, and wear a small monitoring patch that records safety information such as heart rate and other vital signs. The study follows participants for a short period after the dose to check for any side effects and to ensure the medication is well tolerated.

1 study enrollment and consent

after agreeing to take part, you sign a consent form that explains the study and your responsibilities.

the study team provides a wearable monitoring device that will record your heart rate and other vital signs during the trial.

2 baseline health assessment

you attend a virtual or in‑person visit where staff measure your blood pressure, heart rate, and perform a simple electrocardiogram (ecg) to record heart activity.

a small laboratory blood sample is taken to check basic health markers before any medication is given.

3 training on study devices

you receive instructions on how to use the tasso device, a tiny patch that collects micro‑blood samples from the arm.

you also learn how to wear and operate the wearable monitoring device that tracks your heart rate and other signs continuously.

4 first treatment period (self‑collected sampling)

you fast for at least eight hours before taking the study medication; this means no food or drink except water.

you take a single oral dose of etrasimod 2 mg tablet with a glass of water.

the tablet is taken under fasted condition and you continue to avoid food for four hours after dosing.

the wearable device records your heart rate and other vital signs for the next 24 hours.

using the tasso device, you collect small blood samples at scheduled times (for example at 0, 1, 2, 4, 8, 12 and 24 hours after the dose).

each sample is labeled and sent back to the study laboratory according to the instructions.

5 washout period

after the first dose, you do not take any more study medication for a washout period that allows the drug to leave your body completely.

during this time you continue to wear the monitoring device only if instructed, and you avoid any new medications that could affect the study.

6 second treatment period (staff‑collected sampling)

you again fast for at least eight hours before dosing.

you take a second single oral dose of etrasimod 2 mg tablet with water, following the same fasted schedule as before.

the wearable monitoring device remains active and records your heart rate for the next 24 hours.

this time, a study staff member at the clinical research unit (cru) collects the blood samples at the same scheduled times as in the first period.

the staff‑collected samples are processed in the laboratory for pharmacokinetic analysis.

7 final safety assessments

after the second 24‑hour monitoring period, you attend a final visit where blood pressure, heart rate, and an ecg are measured again.

the study team reviews any side effects you experienced and checks laboratory results for any abnormalities.

the wearable device is removed and returned to the study team.

8 study completion

all data from your medication dose, blood samples, and monitoring device are compiled for analysis.

you receive a summary of the study procedures you completed, and the study is formally closed for your participation.

Who Can Join the Study?

  • Be a man or woman who is at least 18 years old (or the legal age for consent in your country) and be in good health, as shown by a doctor’s review of your medical history, a full physical exam, checks of blood pressure (BP) (the force of blood moving through your vessels) and pulse rate (how fast your heart beats), lab tests, temperature, and a simple heart test called a 12‑lead ECG (records the heart’s electrical activity).
  • Have a body mass index (BMI) between 16 and 32 (a measure that compares height and weight) and weigh more than 50 kg (about 110 lb).
  • Be willing and able to follow all study visits, take the medication as planned, complete lab tests, and follow any lifestyle instructions given by the study team.
  • Be able to sign a document called informed consent, which means you understand the study and agree to take part.

Who Cannot Join the Study?

  • Having a serious medical problem affecting the blood (hematological), kidneys (renal), hormone glands (endocrine), lungs (pulmonary), stomach or intestines (gastrointestinal), heart and blood vessels (cardiovascular), liver (hepatic), mental health (psychiatric), nerves (neurological), severe allergies (anaphylactic), or eyes (such as swelling in the central retina called macular edema, eye inflammation called uveitis, or damage to the retina called retinopathy).
  • Any condition that could change how the drug is absorbed, such as having had the stomach removed (gastrectomy) or the gallbladder removed (cholecystectomy).
  • Having a known immune‑system deficiency, including a positive test for human immunodeficiency virus (HIV), or having a close family member (parent, sibling, or child) with an inherited immune deficiency.
  • Having an infection with hepatitis B or hepatitis C viruses as shown by the study’s testing.
  • Having any current or past serious infection, whether short‑term (acute) or long‑term (chronic).
  • Having had a feverish illness within 5 days before taking the first dose of the study medication.
  • Having a history of diseases that affect the lymphatic system, such as problems caused by Epstein‑Barr virus (EBV), lymphoma (cancer of the lymph nodes), leukemia (cancer of blood‑forming cells), or any signs that suggest a current problem with the lymph nodes or related tissues (lymphoproliferative disorder).
  • Having a current or past cancer, except for a skin cancer that was completely removed and did not spread (basal cell or squamous cell carcinoma) or a very early cervical cancer that was treated in place (cervical carcinoma in situ).
  • Having active or hidden (latent) Mycobacterium tuberculosis (TB) infection that has not been treated adequately.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Pfizer Clinical Research Unit Brussels Belgium

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
10.11.2023

Trial locations

Investigated Drugs:

Etrasimod Arginine Blue is an oral tablet taken in a single dose. It contains the active ingredient etrasimod, which is being studied to see how it moves through the body and is cleared. In this trial healthy volunteers swallow the tablet while fasting, and researchers measure how much of the drug appears in tiny blood samples.

Tasso micro‑sampling device is a small, wearable tool that collects tiny drops of blood from the participant’s arm. Participants can place the device on themselves to obtain blood samples without needing a nurse or clinic visit. The collected samples are used to measure the amount of etrasimod in the blood.

Wearable monitoring devices are sensors that participants wear, such as patches or wristbands, that continuously track vital signs like heart rate, temperature, and activity. These devices help the study team watch for any safety concerns or side effects after the tablet is taken.

Ulcerative colitis – a long‑lasting inflammation of the inner lining of the colon that creates ulcers and can cause diarrhea, rectal bleeding, and abdominal pain. The inflammation usually starts in the rectum and may spread continuously upward through the colon. Symptoms often come and go in periods called flares and remissions. Over time the disease can become more extensive, affecting larger parts of the colon. Severe inflammation may lead to narrowing of the colon and changes in bowel habits.

Alopecia areata – an autoimmune disorder in which the immune system attacks hair follicles, causing smooth, round patches of hair loss on the scalp or other body areas. In some people the patches stay small, while in others they expand or progress to total scalp loss (alopecia totalis) or loss of all body hair (alopecia universalis). The condition can appear suddenly and may recur after regrowth. The pattern and speed of hair loss vary widely between individuals.

Atopic dermatitis – a chronic, itchy skin condition that often begins in childhood and appears as red, inflamed patches on the flexural areas such as elbows and knees. The rash may flare up repeatedly, becoming more widespread or thickened with repeated scratching. Over time the skin can become dry, cracked, and lichenified (thickened). The disease course is characterized by periods of worsening symptoms followed by calmer phases.

Eosinophilic esophagitis – a long‑term allergic inflammation of the esophagus marked by a buildup of eosinophils, a type of white blood cell. It leads to difficulty swallowing, feeling that food is stuck, and occasional food blockage. Repeated inflammation can cause the esophagus to narrow or develop rings. Symptoms often worsen gradually as the condition persists.

Trial ID:
2023-508119-22-00
Protocol code:
C5041050
Trial Phase:
Human Pharmacology (Phase I) – Other

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