Overview
Sponsor-declared trial summary
Inflammatory Conditions
To assess the rate and extent of absorption and the bioavailability of JNJ-77242113 when administered as Phase 3 IR tablet formulation relative to the Phase 2 IR tablet formulation under fasted conditions, in healthy participants.
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 19 Jul 2023 → 11 Sep 2023
- Decision date (initial)
- 2023-06-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Others, Safety
To assess the rate and extent of absorption and the bioavailability of JNJ-77242113 when administered as Phase 3 IR tablet formulation relative to the Phase 2 IR tablet formulation under fasted conditions, in healthy participants.
Conditions and MedDRA coding
Inflammatory Conditions
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Male or female, 18 to 60 years of age, inclusive, at screening.
- 2. Healthy on the basis of physical examination, medical history, and vital signs, and 12-lead ECG performed at screening and/or before receiving the first dose of study drug.
- 3. Healthy on the basis of clinical laboratory tests performed at screening and/or before receiving the first dose of study drug.
- 4. Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50.0 kg at screening.
- 5. Women must not be of childbearing potential (postmenopausal or permanently sterile).
Exclusion criteria 5
- 1. History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
- 2. History of malignancy before screening.
- 3. Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients.
- 4. History of gastrointestinal disease.
- 5. History of surgical resection.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Area under the plasma analyte concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUClast), AUC from time 0 to infinite time (AUC∞), and maximum observed plasma analyte concentration (Cmax) after a single oral dose of the Phase 3 IR vs the Phase 2 IR tablet.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10321777 · Product
- Active substance
- JNJ-77242113-AAC
- Substance synonyms
- PN-235 hydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10321776 · Product
- Active substance
- JNJ-77242113-AAC
- Substance synonyms
- PN-235 hydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Venn Life Sciences Ed B.V. ORG-100011859
|
Breda, Netherlands | Code 11 |
| SGS Belgium ORG-100007917
|
Mechelen, Belgium | Code 10, Code 11, Other, Data management |
| Pharmaceutical Research Associates Group B.V. ORG-100006268
|
Assen, Netherlands | Laboratory analysis |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 24 | 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 | 2023-07-19 | 2023-09-11 | 2023-07-19 | 2023-08-21 |
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 |
|---|---|---|---|
| 77242113PSO1006 Summary of Results SUM-44140
|
2024-09-04T14:35:58 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| 77242113PSO1006 Lay person summary of results | 2024-09-04T14:36:08 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 77242113PSO1006_PLS_09Aug2024_NL-BE | 1 |
| Summary of results (for publication) | 77242113PSO1006 Summary of Results | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-18 | Belgium | Acceptable 2023-06-28
|
2023-06-28 |