HealthyPhase 1NCT04330248
A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants
A Phase 1 study testing Erdafitinib and Carbamazepine in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in Belgium.
Trial summary
The main purpose of this study is to evaluate the effect of multiple doses of carbamazepine (a strong inducer of cytochrome P450 [CYP]3A4 and a weak inducer of CYP2C9) on the pharmacokinetics of a single oral dose of erdafitinib in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Erdafitinib and Carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Mar 2020to 14 Jun 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy on the basis of physical examination, medical history, and vital signs (blood pressure, pulse, and body temperature) performed at screening
- Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel and hematology panel are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator. Participants must have sodium and phosphate levels within normal limits; hematological parameters (Hemoglobin, red blood cell [RBC] count, white blood cell [WBC] count, absolute neutrophil count, platelet count) within normal limits; and total bilirubin, alanine aminotransferase (ALT), aspartate amino transferase (AST), and alkaline phosphatase (ALP) serum levels lower than or equal to the upper limit of normal at screening
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Must agree to have a pharmacogenomic blood sample (5 milliliters [mL]) collected at screening to allow for pharmacogenomic analysis
- Non-smoker for at least 6 months before first study drug administration
Who cannot join
- History of depression or suicidal ideation
- 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
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (a maximum of 3 doses per day of 500 milligram [mg] paracetamol, and no more than 3 gram [g] per week), hormonal replacement therapy and cetirizine (in case of allergic reactions), within 14 days before the first dose of the study drug is scheduled until completion of the study
- Received an experimental drug or used an experimental medical device within 1 month or within a period less than 5 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled
- Known allergies, hypersensitivity, or intolerance to erdafitinib or carbamazepine or any of the excipients of the formulations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-sequence, Drug-drug Interaction Study to Evaluate the Effect of Steady-state Carbamazepine on the Single-dose Pharmacokinetics of Erdafitinib Tablets in Healthy Adult Subjects
The main purpose of this study is to evaluate the effect of multiple doses of carbamazepine (a strong inducer of cytochrome P450 [CYP]3A4 and a weak inducer of CYP2C9) on the pharmacokinetics of a single oral dose of erdafitinib in healthy adult participants.
- Conditions
- Healthy
- Being tested
- Erdafitinib, Carbamazepine
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 single oral dose of erdafitinib tablets on Day 1 in Period 1 and on Day 28 in Period 2.
CarbamazepineDrug
Participants will receive an oral dose of carbamazepine tablets from Day 15 to 35 in Period 2.
| Study group | Role | What they receive |
|---|---|---|
| Erdafitinib and Carbamazepine | Experimental | Participants will receive single oral dose of erdafitinib dose 1 on Day 1 30 minutes after the start of a standardized breakfast in Period 1 followed by repeated doses of carbamazepine orally every 12 hours from Days 15 to 35 (carbamazepine Dose 1 from Days 15 to 17, Dose 2 from Days 18 to 20, and then Dose 3 from Days 21 to 35) 30 minutes after the start of standardized meal (breakfast and dinner) in Period 2. After 8 Days of Dose 3 carbamazepine treatment, on Day 28, participants will receive a single oral dose of erdafitinib dose 1 with that day's carbamazepine dose. Receives: Drug: Erdafitinib; Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma (Cmax) of Erdafitinib
Cmax is defined as the maximum observed plasma of erdafitinib concentration.
Measured: Predose (Day 28) 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 and 312 hours postdose (Day 41)
Area Under the Plasma Analyte Concentration-Time Curve 0 from Time 0 to one week Postdose (AUC[0-168 hours])
AUC (0-168 hours) is defined as the area under the plasma analyte concentration-time curve from time 0 to one week postdose (168 hours).
Measured: Predose (Day 28) 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 168 hours postdose (Day 35)
Area Under the Plasma Analyte Concentration-Time Curve from Time 0 to Time of the Last Observed Quantifiable Concentration (AUC [0-last])
AUC (0-last) is defined as area under the plasma analyte concentration-time curve from time 0 to time of the last observed quantifiable concentration.
Measured: Predose (Day 28) 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 and 312 hours postdose (Day 41)
Area Under the Analyte Concentration-Time Curve from Time 0 to Infinite Time (AUC [0-infinity])
AUC (0-infinity) is defined as the area under the analyte concentration-time curve from time 0 to infinite time.
Measured: Predose (Day 28) 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 and 312 hours postdose (Day 41)
Secondary outcomes (1)
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Up to Day 79 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start31 Mar 2020
- Primary completion14 Jun 2022
- Study completion14 Jun 2022
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330248
- Sponsor's protocol ID
- CR108763
- Other IDs
- 2019-003473-26, 42756493NAP1001, 2019
- Status last verified
- Jun 2023
- First submitted
- 31 Mar 2020
- Last updated
- 29 Jun 2023
- 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 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-sequence, Drug-drug Interaction Study to Evaluate the Effect of Steady-state Carbamazepine on the Single-dose Pharmacokinetics of Erdafitinib Tablets in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04330248
- Acronym / sponsor ID
- CR108763
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 1 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 this study is to evaluate the effect of multiple doses of carbamazepine (a strong inducer of cytochrome P450 [CYP]3A4 and a weak inducer of CYP2C9) on the pharmacokinetics of a single oral dose of erdafitinib in healthy adult participants.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erdafitinib and Carbamazepine | Experimental | Drug: Erdafitinib, Drug: CarbamazepineParticipants will receive single oral dose of erdafitinib dose 1 on Day 1 30 minutes after the start of a standardized breakfast in Period 1 followed by repeated doses of carbamazepine orally every 12 hours from Days 15 to 35 (carbamazepine Dose 1 from Days 15 to 17, Dose 2 from Days 18 to 20, and then Dose 3 from Days 21 to 35) 30 minutes after the start of standardized meal (breakfast and dinner) in Period 2. After 8 Days of Dose 3 carbamazepine treatment, on Day 28, participants will receive a single oral dose of erdafitinib dose 1 with that day's carbamazepine dose. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy on the basis of physical examination, medical history, and vital signs (blood pressure, pulse, and body temperature) performed at screening
- Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel and hematology panel are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator. Participants must have sodium and phosphate levels within normal limits; hematological parameters (Hemoglobin, red blood cell [RBC] count, white blood cell [WBC] count, absolute neutrophil count, platelet count) within normal limits; and total bilirubin, alanine aminotransferase (ALT), aspartate amino transferase (AST), and alkaline phosphatase (ALP) serum levels lower than or equal to the upper limit of normal at screening
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Must agree to have a pharmacogenomic blood sample (5 milliliters [mL]) collected at screening to allow for pharmacogenomic analysis
- Non-smoker for at least 6 months before first study drug administration
Key exclusion criteria (5 listed)
- History of depression or suicidal ideation
- 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
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (a maximum of 3 doses per day of 500 milligram [mg] paracetamol, and no more than 3 gram [g] per week), hormonal replacement therapy and cetirizine (in case of allergic reactions), within 14 days before the first dose of the study drug is scheduled until completion of the study
- Received an experimental drug or used an experimental medical device within 1 month or within a period less than 5 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled
- Known allergies, hypersensitivity, or intolerance to erdafitinib or carbamazepine or any of the excipients of the formulations
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 single oral dose of erdafitinib tablets on Day 1 in Period 1 and on Day 28 in Period 2. | Drug | Erdafitinib and Carbamazepine |
| CarbamazepineParticipants will receive an oral dose of carbamazepine tablets from Day 15 to 35 in Period 2. | Drug | Erdafitinib and Carbamazepine |
Primary outcome
Maximum Observed Plasma (Cmax) of Erdafitinib
Time frame: Predose (Day 28) 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 and 312 hours postdose (Day 41)
Cmax is defined as the maximum observed plasma of erdafitinib concentration.
Area Under the Plasma Analyte Concentration-Time Curve 0 from Time 0 to one week Postdose (AUC[0-168 hours])
Time frame: Predose (Day 28) 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 168 hours postdose (Day 35)
AUC (0-168 hours) is defined as the area under the plasma analyte concentration-time curve from time 0 to one week postdose (168 hours).
Area Under the Plasma Analyte Concentration-Time Curve from Time 0 to Time of the Last Observed Quantifiable Concentration (AUC [0-last])
Time frame: Predose (Day 28) 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 and 312 hours postdose (Day 41)
AUC (0-last) is defined as area under the plasma analyte concentration-time curve from time 0 to time of the last observed quantifiable concentration.
Area Under the Analyte Concentration-Time Curve from Time 0 to Infinite Time (AUC [0-infinity])
Time frame: Predose (Day 28) 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 and 312 hours postdose (Day 41)
AUC (0-infinity) is defined as the area under the analyte concentration-time curve from time 0 to infinite time.
1 secondary outcome
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
Time frame: Up to Day 79 (end of study)
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 29 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.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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 Erdafitinib and Carbamazepine in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in Belgium.
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 29 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 Belgium. 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?
Maximum Observed Plasma (Cmax) of Erdafitinib (time frame: Predose (Day 28) 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 and 312 hours postdose (Day 41)). The study lists 4 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 29 Jun 2023.