HealthyPhase 1NCT03066687
A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants
A Phase 1 study testing Erdafitinib in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the effect of food on the relative bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy participants. 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?
- Erdafitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2017to 12 May 2017
- 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
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- If a woman, must be not of childbearing potential: postmenopausal (greater than [>] 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 12 months and a serum follicle stimulating hormone [FSH] >40 International Units Per Liter [IU/L]); or surgically sterile
- If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and on Day -1 of Period 1 and Period 2
- 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 last study drug administration
- Body mass index (BMI; weight [kg]/height^2 [m]^2) between 18 and 32 kilogram per square meter (kg/m^2) (inclusive), and body weight not less than 50 kg
- Non-smoker for at least 6 months before first study drug administration
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), 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
- 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
- Clinically significant abnormal values for hematology, serum chemistry, or urinalysis at screening as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen and hormonal replacement therapy, within 14 days before the first dose of the study drug is scheduled until completion of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open-Label, 2-Way Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Subjects
The primary purpose of this study is to evaluate the effect of food on the relative bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy participants.
- Conditions
- Healthy
- Being tested
- Erdafitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErdafitinibDrug
Erdafitinib 9 mg (provided as one 4-mg tablet [G-024] and one 5-mg tablet [G-025]) will be administered orally on Day 1 in each Treatment Period of assigned sequence.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1: Erdafitinib 9 mg | Experimental | Participants will receive 9 milligram (mg) dose of erdafitinib under fasted condition [Treatment A] in Period 1, and under fed (with high-fat and high-calorie breakfast) condition [Treatment B] in Period 2. Each Treatment Period will be separated by a washout of at least 28 days. Receives: Drug: Erdafitinib |
| Treatment Sequence 2: Erdafitinib 9 mg | Experimental | Participants will receive 9 mg dose of erdafitinib under fed (high-fat and high-calorie breakfast) condition [Treatment B] in Period 1, and under fasted condition [Treatment A] in Period 2. Each Treatment Period will be separated by a washout of at least 28 days. 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)
The Cmax is the maximum observed plasma concentration.
Measured: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Measured: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Measured: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose
Secondary outcomes (1)
Number of Participants With Adverse Events
Safety and Tolerability
Measured: Baseline, up to end of study (Day 15 of Period 2) or early withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start14 Mar 2017
- Primary completion12 May 2017
- Study completion12 May 2017
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066687
- Sponsor's protocol ID
- CR108289
- Other IDs
- 42756493EDI1006
- Status last verified
- Jun 2017
- First submitted
- 23 Feb 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label, 2-Way Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03066687
- Acronym / sponsor ID
- CR108289
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 12 May 2017 (actual)
- Study completion
- 12 May 2017 (actual)
- First posted
- 28 Feb 2017 (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 this study is to evaluate the effect of food on the relative bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1: Erdafitinib 9 mg | Experimental | Drug: ErdafitinibParticipants will receive 9 milligram (mg) dose of erdafitinib under fasted condition [Treatment A] in Period 1, and under fed (with high-fat and high-calorie breakfast) condition [Treatment B] in Period 2. Each Treatment Period will be separated by a washout of at least 28 days. |
| Treatment Sequence 2: Erdafitinib 9 mg | Experimental | Drug: ErdafitinibParticipants will receive 9 mg dose of erdafitinib under fed (high-fat and high-calorie breakfast) condition [Treatment B] in Period 1, and under fasted condition [Treatment A] in Period 2. Each Treatment Period will be separated by a washout of at least 28 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- If a woman, must be not of childbearing potential: postmenopausal (greater than [>] 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 12 months and a serum follicle stimulating hormone [FSH] >40 International Units Per Liter [IU/L]); or surgically sterile
- If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and on Day -1 of Period 1 and Period 2
- 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 last study drug administration
- Body mass index (BMI; weight [kg]/height^2 [m]^2) between 18 and 32 kilogram per square meter (kg/m^2) (inclusive), and body weight not less than 50 kg
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), 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
- 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
- Clinically significant abnormal values for hematology, serum chemistry, or urinalysis at screening as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen and hormonal replacement therapy, within 14 days before the first dose of the study drug is scheduled until completion 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 |
|---|---|---|
| ErdafitinibErdafitinib 9 mg (provided as one 4-mg tablet [G-024] and one 5-mg tablet [G-025]) will be administered orally on Day 1 in each Treatment Period of assigned sequence. | Drug | Treatment Sequence 1: Erdafitinib 9 mg, Treatment Sequence 2: Erdafitinib 9 mg |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose
The Cmax is the maximum observed plasma concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
Time frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Time frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
1 secondary outcome
Number of Participants With Adverse Events
Time frame: Baseline, up to end of study (Day 15 of Period 2) or early withdrawal
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 23 Jun 2017.
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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 Erdafitinib in people with Healthy, run by Janssen Research & Development, LLC at 1 site 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 6 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 23 Jun 2017. 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 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 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 Concentration (Cmax) (time frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose). 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 23 Jun 2017; AzTrials last refreshed its copy on 7 Nov 2026.