Hepatic ImpairmentPhase 1NCT04332523
A Study of JNJ-53718678 in Participants With Hepatic Impairment
A Phase 1 study testing JNJ-53718678 in people with Hepatic Impairment, run by Janssen Research & Development, LLC at 2 sites in United States.
Trial summary
The main purpose of the study is to evaluate the pharmacokinetc (PK) of a single oral dose of JNJ-53718678 in participants with varying degrees of impaired hepatic function (mild, moderate, and severe) when compared with participants with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- JNJ-53718678
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Aug 2020to 16 Mar 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [beta-HCG]) test at screening and on Day -1 of the treatment period
- Contraceptive use by female participants or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
- If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 30 days after receiving the study drug
- A male participant must agree not to donate sperm for the purpose of reproduction from Day -1 of the study and for a minimum of 90 days after receiving the study drug
- For participants with mild, moderate or severe hepatic impairment: the participants must have a total Child-Pugh score of 5 to 6, inclusive (mild); or 7 to 9, inclusive (moderate); or 10-15, inclusive (severe). The Investigator will determine degree of hepatic impairment
Who cannot join
- Known allergies, hypersensitivity, or intolerance to JNJ-53718678 or its excipients
- Donated blood or blood products or had substantial loss of blood (more than 500 milliliter [mL]) within 90 days before the administration of study drug or intention to donate blood or blood products during the study
- Received an experimental drug (including investigational vaccines) or used an experimental medical device within 30 days or within a period less than 5 times the drug's half-life, whichever is longer, before the dose of the study drug is scheduled
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
- Preplanned surgery or procedures that would interfere with the conduct of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Orlando Clinical Research Center
Orlando, Florida, 32809
The Texas Liver Institute
San Antonio, Texas, 78215
About this study
Official title: A Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on the Pharmacokinetics of JNJ-53718678
The main purpose of the study is to evaluate the pharmacokinetc (PK) of a single oral dose of JNJ-53718678 in participants with varying degrees of impaired hepatic function (mild, moderate, and severe) when compared with participants with normal hepatic function.
- Conditions
- Hepatic Impairment
- Being tested
- JNJ-53718678
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-53718678Drug
Also called Rilematovir
Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Participants with Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1. Receives: Drug: JNJ-53718678 |
| Group 2: Participants with Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1. Receives: Drug: JNJ-53718678 |
| Group 3: Participants with Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1. Receives: Drug: JNJ-53718678 |
| Group 4: Participants with Normal Hepatic Function | Experimental | Participants with normal hepatic function will receive a single oral dose of JNJ-53718678 suspension on Day 1. Receives: Drug: JNJ-53718678 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of JNJ-53718678
Cmax is defined as the maximum plasma concentration of JNJ-53718678.
Measured: Predose, 15 minutes (min), 30 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose
Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of JNJ-53718678
AUClast is defined as the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of JNJ-53718678.
Measured: Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose
Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity])
AUC(0-infinity) is defined as the area under the plasma concentration-time curve from time 0 to infinite time calculated as the sum of AUClast and Clast/lz, in which Clast is the last observed quantifiable concentration.
Measured: Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose
Secondary outcomes (1)
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.
Measured: From screening up to Day 14 (Up to 42 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start17 Aug 2020
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Why it stopped: A strategic decision was made to discontinue the study. The decision was not based on a safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT04332523
- Sponsor's protocol ID
- CR108773
- Other IDs
- 53718678RSV1010
- Status last verified
- Jun 2022
- First submitted
- 1 Apr 2020
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on the Pharmacokinetics of JNJ-53718678
- ClinicalTrials.gov ID
- NCT04332523
- Acronym / sponsor ID
- CR108773
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A strategic decision was made to discontinue the study. The decision was not based on a safety concern.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 2 Apr 2020 (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 main purpose of the study is to evaluate the pharmacokinetc (PK) of a single oral dose of JNJ-53718678 in participants with varying degrees of impaired hepatic function (mild, moderate, and severe) when compared with participants with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Participants with Mild Hepatic Impairment | Experimental | Drug: JNJ-53718678Participants with mild hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1. |
| Group 2: Participants with Moderate Hepatic Impairment | Experimental | Drug: JNJ-53718678Participants with moderate hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1. |
| Group 3: Participants with Severe Hepatic Impairment | Experimental | Drug: JNJ-53718678Participants with severe hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1. |
| Group 4: Participants with Normal Hepatic Function | Experimental | Drug: JNJ-53718678Participants with normal hepatic function will receive a single oral dose of JNJ-53718678 suspension on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [beta-HCG]) test at screening and on Day -1 of the treatment period
- Contraceptive use by female participants or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
- If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 30 days after receiving the study drug
- A male participant must agree not to donate sperm for the purpose of reproduction from Day -1 of the study and for a minimum of 90 days after receiving the study drug
- For participants with mild, moderate or severe hepatic impairment: the participants must have a total Child-Pugh score of 5 to 6, inclusive (mild); or 7 to 9, inclusive (moderate); or 10-15, inclusive (severe). The Investigator will determine degree of hepatic impairment
Key exclusion criteria (5 listed)
- Known allergies, hypersensitivity, or intolerance to JNJ-53718678 or its excipients
- Donated blood or blood products or had substantial loss of blood (more than 500 milliliter [mL]) within 90 days before the administration of study drug or intention to donate blood or blood products during the study
- Received an experimental drug (including investigational vaccines) or used an experimental medical device within 30 days or within a period less than 5 times the drug's half-life, whichever is longer, before the dose of the study drug is scheduled
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
- Preplanned surgery or procedures that would interfere with the conduct of the study
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-53718678Also: RilematovirParticipants will receive a single oral dose of JNJ-53718678 suspension on Day 1. | Drug | Group 1: Participants with Mild Hepatic Impairment, Group 2: Participants with Moderate Hepatic Impairment, Group 3: Participants with Severe Hepatic Impairment, Group 4: Participants with Normal Hepatic Function |
Primary outcome
Maximum Plasma Concentration (Cmax) of JNJ-53718678
Time frame: Predose, 15 minutes (min), 30 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose
Cmax is defined as the maximum plasma concentration of JNJ-53718678.
Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of JNJ-53718678
Time frame: Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose
AUClast is defined as the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of JNJ-53718678.
Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity])
Time frame: Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose
AUC(0-infinity) is defined as the area under the plasma concentration-time curve from time 0 to infinite time calculated as the sum of AUClast and Clast/lz, in which Clast is the last observed quantifiable concentration.
1 secondary outcome
Number of Participants with Adverse Events (AEs)
Time frame: From screening up to Day 14 (Up to 42 days)
Results and safety
The study was stopped early (reason given: A strategic decision was made to discontinue the study. The decision was not based on a safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- 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
2 sites 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-53718678 in people with Hepatic Impairment, run by Janssen Research & Development, LLC at 2 sites in United States.
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: stopped early, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was stopped early (reason given: A strategic decision was made to discontinue the study. The decision was not based on a safety concern.). Results are not available in the source record.
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?
Maximum Plasma Concentration (Cmax) of JNJ-53718678 (time frame: Predose, 15 minutes (min), 30 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose). The study lists 3 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 13 Jun 2022.