Hepatic ImpairmentPhase 1NCT03587363
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib
A Phase 1 study testing Erdafitinib in people with Hepatic Impairment, run by Janssen Research & Development, LLC at 2 sites in Germany.
Trial summary
The primary purpose of the study is to characterize the single dose pharmacokinetic of erdafitinib in participants with impaired hepatic function relative to participants with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Erdafitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesGermany
- Study dates
- 6 Dec 2018to 22 Dec 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Man or woman must have a clinically stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during screening and those measured on Day -1
- If a woman (a) must not be of childbearing potential postmenopausal or surgically sterile (b) must agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after the study drug administration
- If a woman who is considered surgically sterile but not postmenopausal, must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening (exemptions: pregnancy test not required in female participants with prior hysterectomy or prior bilateral oophorectomy)
- If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after the study drug administration
- Participants with hepatic impairment must meet the Child-pug classification for mild, moderate or severe hepatic impairment and must have stable hepatic function
Who cannot join
- History or current evidence of ophthalmic disorder, such as central serous retinopathy (CSR) or retinal vein occlusion, active wet age related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
- Any surgical or medical condition that may alter the absorption, metabolism, or excretion of the study drug (example, gastrectomy, Crohn's disease etc), with the exception of hepatic impairment
- History of drug abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 6 months before screening or positive test result(s) for drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines, hallucinogens, and benzodiazepines) at screening and on Day -1
- Known allergy to the study drug or any of the excipients of the formulation (Physical Description of Study Drug[s], for a list of excipients)
- Donated blood or blood products or had substantial loss of blood (more than 500 milliliter [mL]) within 3 months before study drug administration or intention to donate blood or blood products during the study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
CRS Clinical Research Services Kiel GmbH
Kiel, 24105
APEX GmbH
München, 81241
About this study
Official title: A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib
The primary purpose of the study is to characterize the single dose pharmacokinetic of erdafitinib in participants with impaired hepatic function relative to participants with normal hepatic function.
- Conditions
- Hepatic Impairment
- Being tested
- Erdafitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErdafitinibDrug
Also called JNJ-42756493
Participants will receive 6 mg (2*3 mg tablet) erdafitinib as a single oral dose on Day 1. Participants in Cohort 4 may receive a lower dose if warranted by preliminary safety and PK data from Cohorts 2 and 3.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Normal Hepatic Function | Experimental | Participants with normal hepatic function will receive 6 milligram (mg) erdafitinib as a single oral dose under fasted conditions on Day 1. Receives: Drug: Erdafitinib |
| Cohort 2: Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment (Child-Pugh score of 5 or 6) will receive 6 mg erdafitinib as a single oral dose under fasted conditions on Day 1. Receives: Drug: Erdafitinib |
| Cohort 3: Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment (Child-Pugh score of 7 to 9) will receive 6 mg erdafitinib as a single oral dose under fasted conditions on Day 1. Receives: Drug: Erdafitinib |
| Cohort 4: Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment (Child-Pugh score of 10 to 15) will only be enrolled to receive appropriate dose level of erdafitinib after review of preliminary safety and pharmacokinetic (PK) data from the mild and moderate hepatic impairment cohorts. Receives: Drug: Erdafitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Cmax is the maximum observed plasma concentration.
Measured: Up to 21 days
Time to Reach the Maximum Observed Plasma Concentration (Tmax)
Tmax is the time to reach maximum observed plasma concentration.
Measured: Up to 21 days
Area Under Plasma Concentration-Time Curve (AUC)
AUC is area under plasma concentration-time curve.
Measured: Up to 21 days
Terminal Elimination Half-life (t1/2term, Lambda)
t1/2term, Lambda is elimination half-life associated with the terminal slope (Lambda[Z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda(Z).
Measured: Up to 21 days
Total Plasma Clearance (CL/F)
CL/F is total plasma clearance of drug after extravascular administration, uncorrected for absolute bioavailability (BA), calculated as Dose/AUC (0-infinity).
Measured: Up to 21 days
Apparent Volume of Distribution (Vd/F)
Vd/F is apparent volume of distribution after extravascular administration, uncorrected for absolute BA.
Measured: Up to 21 days
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily have a causal relationship with the relevant investigational product.
Measured: Approximately 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start6 Dec 2018
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
Why it stopped: Mild/moderate hepatic impairment (HI) cohorts completed with no impact to erdafitinib exposure. Severe HI cohort enrollment stopped early.
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT03587363
- Sponsor's protocol ID
- CR108483
- Other IDs
- 2018-001104-11, 42756493EDI1008, 2018
- Status last verified
- Jan 2025
- First submitted
- 4 Jul 2018
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib
- ClinicalTrials.gov ID
- NCT03587363
- Acronym / sponsor ID
- CR108483
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Mild/moderate hepatic impairment (HI) cohorts completed with no impact to erdafitinib exposure. Severe HI cohort enrollment stopped early.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 16 Jul 2018 (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 primary purpose of the study is to characterize the single dose pharmacokinetic of erdafitinib in participants with impaired hepatic function relative to participants with normal hepatic function.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Normal Hepatic Function | Experimental | Drug: ErdafitinibParticipants with normal hepatic function will receive 6 milligram (mg) erdafitinib as a single oral dose under fasted conditions on Day 1. |
| Cohort 2: Mild Hepatic Impairment | Experimental | Drug: ErdafitinibParticipants with mild hepatic impairment (Child-Pugh score of 5 or 6) will receive 6 mg erdafitinib as a single oral dose under fasted conditions on Day 1. |
| Cohort 3: Moderate Hepatic Impairment | Experimental | Drug: ErdafitinibParticipants with moderate hepatic impairment (Child-Pugh score of 7 to 9) will receive 6 mg erdafitinib as a single oral dose under fasted conditions on Day 1. |
| Cohort 4: Severe Hepatic Impairment | Experimental | Drug: ErdafitinibParticipants with severe hepatic impairment (Child-Pugh score of 10 to 15) will only be enrolled to receive appropriate dose level of erdafitinib after review of preliminary safety and pharmacokinetic (PK) data from the mild and moderate hepatic impairment cohorts. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Man or woman must have a clinically stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during screening and those measured on Day -1
- If a woman (a) must not be of childbearing potential postmenopausal or surgically sterile (b) must agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after the study drug administration
- If a woman who is considered surgically sterile but not postmenopausal, must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening (exemptions: pregnancy test not required in female participants with prior hysterectomy or prior bilateral oophorectomy)
- If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after the study drug administration
- Participants with hepatic impairment must meet the Child-pug classification for mild, moderate or severe hepatic impairment and must have stable hepatic function
Key exclusion criteria (5 listed)
- History or current evidence of ophthalmic disorder, such as central serous retinopathy (CSR) or retinal vein occlusion, active wet age related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
- Any surgical or medical condition that may alter the absorption, metabolism, or excretion of the study drug (example, gastrectomy, Crohn's disease etc), with the exception of hepatic impairment
- History of drug abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 6 months before screening or positive test result(s) for drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines, hallucinogens, and benzodiazepines) at screening and on Day -1
- Known allergy to the study drug or any of the excipients of the formulation (Physical Description of Study Drug[s], for a list of excipients)
- Donated blood or blood products or had substantial loss of blood (more than 500 milliliter [mL]) within 3 months before study drug administration or intention to donate blood or blood products during 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 |
|---|---|---|
| ErdafitinibAlso: JNJ-42756493Participants will receive 6 mg (2*3 mg tablet) erdafitinib as a single oral dose on Day 1. Participants in Cohort 4 may receive a lower dose if warranted by preliminary safety and PK data from Cohorts 2 and 3. | Drug | Cohort 1: Normal Hepatic Function, Cohort 2: Mild Hepatic Impairment, Cohort 3: Moderate Hepatic Impairment, Cohort 4: Severe Hepatic Impairment |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 21 days
Cmax is the maximum observed plasma concentration.
Time to Reach the Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to 21 days
Tmax is the time to reach maximum observed plasma concentration.
Area Under Plasma Concentration-Time Curve (AUC)
Time frame: Up to 21 days
AUC is area under plasma concentration-time curve.
Terminal Elimination Half-life (t1/2term, Lambda)
Time frame: Up to 21 days
t1/2term, Lambda is elimination half-life associated with the terminal slope (Lambda[Z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda(Z).
Total Plasma Clearance (CL/F)
Time frame: Up to 21 days
CL/F is total plasma clearance of drug after extravascular administration, uncorrected for absolute bioavailability (BA), calculated as Dose/AUC (0-infinity).
Apparent Volume of Distribution (Vd/F)
Time frame: Up to 21 days
Vd/F is apparent volume of distribution after extravascular administration, uncorrected for absolute BA.
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Approximately 50 days
Results and safety
The study was stopped early (reason given: Mild/moderate hepatic impairment (HI) cohorts completed with no impact to erdafitinib exposure. Severe HI cohort enrollment stopped early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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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 Erdafitinib in people with Hepatic Impairment, run by Janssen Research & Development, LLC at 2 sites in Germany.
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 3 Feb 2025. 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 Germany. 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: Mild/moderate hepatic impairment (HI) cohorts completed with no impact to erdafitinib exposure. Severe HI cohort enrollment stopped early.). 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 Observed Plasma Concentration (Cmax) (time frame: Up to 21 days). The study lists 6 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 3 Feb 2025.