HealthyPhase 1NCT05703841
A Study of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants
A Phase 1 study testing JNJ-77242113 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.
Trial summary
The purpose of the study is to assess what drug does to body when healthy Chinese participants receive single oral dose of JNJ-77242113. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-77242113
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2023to 12 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are any abnormalities, they must be consistent with the underlying illness in the study population or considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator
- Body mass index (BMI; weight kilograms [kg] per height [meter^2]) between 18.0 and 27.9 kilograms per meter^2 (kg/m2) (inclusive), and body weight not less than 50.0 kg at screening
- A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and on Day -1
- Blood pressure (after the participant is supine for 5 minutes) between 90 (inclusive) and 140 millimeters of mercury (mmHg) (exclusive) systolic, and no higher than 90 mm Hg diastolic
- Must be a nonsmoker or habitually smokes no more than 5 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before study drug administration
Who cannot join
- History of surgical resection of the stomach, small or large intestine (excluding appendectomy, cholecystectomy, or resection of benign polyps)
- History of use of medications such as nonsteroidal anti-inflammatory drugs (NSAIDS) or aspirin within 28 days prior to screening or planned use during the study
- Clinically significant infection within 30 days prior to screening or any serious infection within 6 months prior to screening requiring intravenous antimicrobial therapy
- Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
- History of severe allergic or anaphylactic reactions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants
The purpose of the study is to assess what drug does to body when healthy Chinese participants receive single oral dose of JNJ-77242113.
- Conditions
- Healthy
- Being tested
- JNJ-77242113
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-77242113Drug
Also called PN-21235, PN-235
JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: JNJ-77242113 Dose 1 | Experimental | Participants will receive a single oral dose of JNJ-77242113 Dose 1 on Day 1. Receives: Drug: JNJ-77242113 |
| Cohort 2: JNJ-77242113 Dose 2 | Experimental | Participants will receive a single oral dose of JNJ-77242113 Dose 2 on Day 1. Receives: Drug: JNJ-77242113 |
| Cohort 3: JNJ-77242113 Dose 3 | Experimental | Participants will receive a single oral dose of JNJ-77242113 Dose 3 on Day 1. Receives: Drug: JNJ-77242113 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration versus Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-77242113
AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to time of the last measurable concentration of JNJ-77242113.
Measured: Predose up to Day 3
Area Under the Plasma Concentration versus Time Curve From Time Zero to Infinite Time (AUC[0-infinite]) of JNJ-77242113
AUC(0-infinite) is defined as area under the plasma concentration versus time curve from time zero to infinite time of JNJ-77242113.
Measured: Predose up to Day 3
Maximum Observed Plasma Concentration (Cmax) of JNJ-77242113
Cmax is defined as maximum observed plasma concentration of JNJ-77242113.
Measured: Predose up to Day 3
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-77242113
Tmax is defined as time to reach the maximum observed plasma concentration of JNJ-77242113.
Measured: Predose up to Day 3
Apparent Elimination Half-life (T1/2) of JNJ-77242113
T1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of JNJ-77242113.
Measured: Predose up to Day 3
Apparent Total Systemic Clearance (CL/F) of JNJ-77242113
CL/F is defined as apparent total systemic clearance after extravascular administration of JNJ-77242113.
Measured: Predose up to Day 3
Apparent Volume of Distribution (Vz/F) of JNJ-77242113
Vz/F is defined as apparent volume based on terminal phase after extravascular administration of distribution of JNJ-77242113.
Measured: Predose up to Day 3
Secondary outcomes (5)
Number of Participants with Abnormalities in Physical Examinations
Number of participants with abnormalities in physical examinations will be reported.
Measured: Up to Day 35
Number of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG)
Number of participants with abnormalities in 12-lead ECGs will be reported.
Measured: Up to Day 35
Number of Participants with Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.
Measured: Up to Day 35
Number of Participants with Abnormalities in Clinical Laboratory Tests
Number of participants with abnormalities in clinical laboratory tests (including hematology, clinical chemistry, and urinalysis) will be reported.
Measured: Up to Day 35
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Measured: Up to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start14 Feb 2023
- Primary completion7 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703841
- Sponsor's protocol ID
- CR109263
- Other IDs
- 77242113PSO1004
- Status last verified
- Jun 2023
- First submitted
- 20 Jan 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants
- ClinicalTrials.gov ID
- NCT05703841
- Acronym / sponsor ID
- CR109263
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess what drug does to body when healthy Chinese participants receive single oral dose of JNJ-77242113.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: JNJ-77242113 Dose 1 | Experimental | Drug: JNJ-77242113Participants will receive a single oral dose of JNJ-77242113 Dose 1 on Day 1. |
| Cohort 2: JNJ-77242113 Dose 2 | Experimental | Drug: JNJ-77242113Participants will receive a single oral dose of JNJ-77242113 Dose 2 on Day 1. |
| Cohort 3: JNJ-77242113 Dose 3 | Experimental | Drug: JNJ-77242113Participants will receive a single oral dose of JNJ-77242113 Dose 3 on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are any abnormalities, they must be consistent with the underlying illness in the study population or considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator
- Body mass index (BMI; weight kilograms [kg] per height [meter^2]) between 18.0 and 27.9 kilograms per meter^2 (kg/m2) (inclusive), and body weight not less than 50.0 kg at screening
- A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and on Day -1
- Blood pressure (after the participant is supine for 5 minutes) between 90 (inclusive) and 140 millimeters of mercury (mmHg) (exclusive) systolic, and no higher than 90 mm Hg diastolic
- Must be a nonsmoker or habitually smokes no more than 5 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before study drug administration
Key exclusion criteria (5 listed)
- History of surgical resection of the stomach, small or large intestine (excluding appendectomy, cholecystectomy, or resection of benign polyps)
- History of use of medications such as nonsteroidal anti-inflammatory drugs (NSAIDS) or aspirin within 28 days prior to screening or planned use during the study
- Clinically significant infection within 30 days prior to screening or any serious infection within 6 months prior to screening requiring intravenous antimicrobial therapy
- Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
- History of severe allergic or anaphylactic reactions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-77242113Also: PN-21235, PN-235JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet. | Drug | Cohort 1: JNJ-77242113 Dose 1, Cohort 2: JNJ-77242113 Dose 2, Cohort 3: JNJ-77242113 Dose 3 |
Primary outcome
Area Under the Plasma Concentration versus Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-77242113
Time frame: Predose up to Day 3
AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to time of the last measurable concentration of JNJ-77242113.
Area Under the Plasma Concentration versus Time Curve From Time Zero to Infinite Time (AUC[0-infinite]) of JNJ-77242113
Time frame: Predose up to Day 3
AUC(0-infinite) is defined as area under the plasma concentration versus time curve from time zero to infinite time of JNJ-77242113.
Maximum Observed Plasma Concentration (Cmax) of JNJ-77242113
Time frame: Predose up to Day 3
Cmax is defined as maximum observed plasma concentration of JNJ-77242113.
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-77242113
Time frame: Predose up to Day 3
Tmax is defined as time to reach the maximum observed plasma concentration of JNJ-77242113.
Apparent Elimination Half-life (T1/2) of JNJ-77242113
Time frame: Predose up to Day 3
T1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of JNJ-77242113.
Apparent Total Systemic Clearance (CL/F) of JNJ-77242113
Time frame: Predose up to Day 3
CL/F is defined as apparent total systemic clearance after extravascular administration of JNJ-77242113.
Apparent Volume of Distribution (Vz/F) of JNJ-77242113
Time frame: Predose up to Day 3
Vz/F is defined as apparent volume based on terminal phase after extravascular administration of distribution of JNJ-77242113.
5 secondary outcomes
Number of Participants with Abnormalities in Physical Examinations
Time frame: Up to Day 35
Number of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG)
Time frame: Up to Day 35
Number of Participants with Abnormalities in Vital Signs
Time frame: Up to Day 35
Number of Participants with Abnormalities in Clinical Laboratory Tests
Time frame: Up to Day 35
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-77242113 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration versus Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-77242113 (time frame: Predose up to Day 3). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.