Overview
Sponsor-declared trial summary
immune-mediated inflammatory disorders, including ulcerative colitis, alopecia areata, atopic dermatitis, and eosinophilic esophagitis
- To estimate the rBA of etrasimod 2 mg mini tablets mixed with water compared to etrasimod 2 mg clinical IR tablets under fasted conditions - To estimate the rBA of the etrasimod 2 mg mini tablets mixed with applesauce compared to the etrasimod 2 mg clinical IR tablets under fasted conditions - To estimate the rBA of …
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 23 Aug 2023 → 5 Jan 2024
- Decision date (initial)
- 2023-06-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Pfizer Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Pharmacokinetic, Safety
- To estimate the rBA of etrasimod 2 mg mini tablets mixed with water compared to etrasimod 2 mg clinical IR tablets under fasted conditions
- To estimate the rBA of the etrasimod 2 mg mini tablets mixed with applesauce compared to the etrasimod 2 mg clinical IR tablets under fasted
conditions
- To estimate the rBA of the etrasimod 2 mg mini tablets mixed with chocolate pudding compared to the etrasimod 2 mg clinical IR tablets under fasted
conditions
- To estimate the rBA of the etrasimod 2 mg mini tablets mixed with yogurt compared to the etrasimod 2 mg clinical IR tablets under fasted conditions
Secondary objectives 2
- To evaluate the safety and tolerability of etrasimod in healthy participants
- To assess the palatability of etrasimod mini tablets mixed with water/applesauce/chocolate pudding/yogurt
Conditions and MedDRA coding
immune-mediated inflammatory disorders, including ulcerative colitis, alopecia areata, atopic dermatitis, and eosinophilic esophagitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10009900 | Colitis ulcerative | 100000004856 |
| 20.1 | PT | 10064212 | Eosinophilic oesophagitis | 100000004856 |
| 21.1 | LLT | 10003639 | Atopic dermatitis | 10040785 |
| 20.0 | PT | 10001761 | Alopecia areata | 100000004858 |
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-002713-PIP01-19, EMEA-002713-PIP02-21
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Male and female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including a detailed medical history, full physical exam, which includes BP and pulse rate measurement, clinical laboratory tests, temperature, and 12-lead ECG.
- BMI of 16 to 32 kg/m2; and a total body weight >50 kg (110 lb).
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Capable of giving signed informed consent.
Exclusion criteria 9
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, anaphylactic, ophthalmologic disorder (such as macular edema, uveitis, retinopathy), or allergic disease.
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- Known immunodeficiency disorder, including positive serology for HIV, or a first degree relative with a hereditary immunodeficiency.
- Infection with hepatitis B or hepatitis C viruses according to protocol specific testing algorithm history.
- Participants with any of the specified acute or chronic infections or infection history.
- History of febrile illness within 5 days prior to the first dose of study intervention.
- History of any lymphoproliferative disorder such as EBV related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease.
- Known present or a history of malignancy other than a successfully treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- Evidence of untreated or inadequately treated active or latent Mycobacterium TB infection.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Plasma AUClast, AUCinf and Cmax of etrasimod
Secondary endpoints 2
- Assessment of first dose HR reduction, TEAEs, clinical laboratory abnormalities, vital signs, PEs, and 12-lead ECGs
- Assessment of palatability via questionnaire: mouth feel, bitterness, tongue/mouth burns, throat burn, and overall liking
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10315876 · Product
- Active substance
- Etrasimod Arginine
- Substance synonyms
- APD334 L-arginine, L-arginine mono((3R)-7-((4-cyclopentyl-3-(trifluoromethyl)phenyl)methoxy)-1,2,3,4-tetrahydrocyclopenta(b)indol-3-yl)acetate, Etrasimod L-arginine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10346457 · Product
- Active substance
- Etrasimod Arginine
- Substance synonyms
- APD334 L-arginine, L-arginine mono((3R)-7-((4-cyclopentyl-3-(trifluoromethyl)phenyl)methoxy)-1,2,3,4-tetrahydrocyclopenta(b)indol-3-yl)acetate, Etrasimod L-arginine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 16 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-08-23 | 2024-01-04 | 2023-09-04 | 2023-10-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| C5041034_ 2023-504411-32-00_Summary of results SUM-33991
|
2024-07-09T14:45:13 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| C5041034_2023-504411-32-00_Lay person summary of results | 2024-07-09T14:51:30 | Submitted | Laypersons Summary of Results |
| C5041034_2023-504411-32-00_Lay person summary of results_French | 2026-03-12T10:18:29 | Submitted | Laypersons Summary of Results |
| C5041034_2023-504411-32-00_Lay person summary of results_Dutch | 2026-03-12T10:19:22 | Submitted | Laypersons Summary of Results |
| C5041034_2023-504411-32-00_Lay person summary of results_German | 2026-03-12T10:19:58 | Submitted | Laypersons Summary of Results |
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | C5041034_2023-504411-32-00_Lay person summary of results | 1 |
| Laypersons summary of results (for publication) | C5041034_2023-504411-32-00_Lay person summary of results_Dutch | 1 |
| Laypersons summary of results (for publication) | C5041034_2023-504411-32-00_Lay person summary of results_French | 1 |
| Laypersons summary of results (for publication) | C5041034_2023-504411-32-00_Lay person summary of results_German | 1 |
| Summary of results (for publication) | C5041034_ 2023-504411-32-00_Summary of results | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-08 | Belgium | Acceptable with conditions 2023-06-09
|
2023-06-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-13 | Belgium | Acceptable with conditions | 2023-08-02 |