HealthyPhase 1NCT02945007

A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-53718678 Administered as Oral Concept Formulation Compared to the Current Oral Solution and to Assess the Effect of Food on the Pharmacokinetics of Oral Concept Formulation

A Phase 1 study testing JNJ-53718678 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the relative bioavailability of 1 to 3 concept formulations of JNJ-53718678 compared to the currently existing oral solution, and to assess the effect of food on the bioavailability of 1 to 3 oral concept formulations of JNJ-53718678 when administered as a single oral dose of 500… 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-53718678
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteBelgium
Study dates: 8 Nov 2016to 16 Jan 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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

At Screening, a female participant must be of non-childbearing potential as defined in the protocol
Female participants must have a negative serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at Screening
A male participant must be sexually abstinent (defined as refraining from sexual intercourse from Day 1 (day of dosing) until 90 days after study drug intake) or who is sexually active (either heterosexual, including with a pregnant woman, or homosexual) must agree to use a barrier method of contraception (example, condom) from Day 1 (day of dosing) until 90 days after study drug intake
Participant must have a body mass index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter^2 (kg/m2), extremes included
Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic

Who cannot join

Participant with a 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 insufficiency, renal dysfunction (calculated creatinine clearance below 60 milliliter per minute (mL/min) at Screening using the Cockroft-Gault equation), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers that it could interfere with the interpretation of the study results should exclude the participant
Participants with abnormal values for either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (greater than or equal to [>=]1.25 x upper limit of laboratory normal range [ULN])
Participants with lack of good/reasonable venous access
Participants with a past history of heart arrhythmias (extrasystoli, tachycardia at rest) or, history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
Participants with a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) criteria within 5 years before Screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, methadone, benzodiazepines, and hallucinogens) at Screening and on Day -1 of each treatment period

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Study site
Merksem

Other trials in Belgium

About this study

Official title: A Phase 1, Open-label, Randomized Crossover Study, in Healthy Adult Subjects to Assess the Relative Oral Bioavailability of a Single 500-mg Dose of JNJ-53718678 Administered as (an) Oral Concept Formulation(s) Compared to the Current Oral Solution and to Assess the Effect of Food on the Pharmacokinetics of (an) Oral Concept Formulation(s)

Conditions: Healthy
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
Participants will receive JNJ-53718678 under fed or fasted conditions.

Study groups in NCT02945007
Study group	Role	What they receive
JNJ-53718678: PART 1	Experimental	Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and B (novel concept formulation 1), and under fed condition for treatment C (novel concept formulation 1). Receives: Drug: JNJ-53718678
JNJ-53718678: PART 2	Experimental	Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and D (novel concept formulation 2), and under fed condition for treatment E (novel concept formulation 2). Part 2 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part. Receives: Drug: JNJ-53718678
JNJ-53718678: PART 3	Experimental	Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and F (novel concept formulation 3), and under fed condition for treatment G (novel concept formulation 3). Part 3 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part. Receives: Drug: JNJ-53718678
JNJ-53718678: PART 4	Experimental	Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and H (novel concept formulation 4), and under fed condition for treatment I (novel concept formulation 4). Part 4 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part. Receives: Drug: JNJ-53718678
JNJ-53718678: PART 5	Experimental	Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and J (novel concept formulation 5), and under fed condition for treatment K (novel concept formulation 5). Part 5 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part. Receives: Drug: JNJ-53718678
JNJ-53718678: PART 6	Experimental	Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and L (novel concept formulation 6), and under fed condition for treatment M (novel concept formulation 6). Part 6 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part. Receives: Drug: JNJ-53718678
JNJ-53718678: PART 7	Experimental	Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and N (novel concept formulation 7), and under fed condition for treatment O (novel concept formulation 7). Part 7 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part. Receives: Drug: JNJ-53718678
JNJ-53718678: PART 8	Experimental	Participants will receive a single dose of JNJ-53718678, 500 mg oral solution under fasted or fed conditions on day 1 for treatment A and P (oral concept formulation 1, 2, 3, 4, 5, 6 or 7) and under fed conditions for treatment Q (oral concept formulation 1, 2, 3, 4, 5, 6 or 7). Part 8 of the study is optional, might be performed, depending on the interim results of prior parts. One of the concept formulations might be re-evaluated under different feeding conditions. Receives: Drug: JNJ-53718678

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678
The Cmax is the maximum observed plasma concentration.
Measured: Up to 72 hour of Post-dose
Area Under the Plasma ConcentrationTime Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0last]) of JNJ-53718678
The AUC (0-last) is the area under the plasma concentration time curve from time 0 to the time of the last measurable non-below quantification limit concentration, calculated by liner-linear trapezoidal summation.
Measured: Up to 72 hour of Post-dose
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-53718678
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: Up to 72 hour of Post-dose
Relative Bioavailability of JNJ-53718678
The relative bioavailability based on Cmax, AUC(0last), and AUC(0-inf) will be estimated as 100*Test/Reference, where Test is defined as the pharmacokinetic parameters of oral JNJ-53718678 and Reference is defined as currently existing oral solution G024.
Measured: Up to 72 hour of Post-dose
Effect of Food on the Bioavailabilty of JNJ-53718678
The effect of food will be evaluated by comparing the pharmacokinetics of JNJ-53718678 under fed conditions with the currently existing oral solution under fasted conditions.
Measured: Up to 72 hour of Post-dose

Secondary outcomes (1)

Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability
Measured: Up to 35 days after last study drug intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 201616 Jan 2020

First posted26 Oct 2016 (estimated)
Study start8 Nov 2016
Primary completion16 Jan 2020
Study completion16 Jan 2020

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: Crossover
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02945007
Sponsor's protocol ID: CR108212
Other IDs: 2016-002665-59, 53718678RSV1007, 2016
Status last verified: Mar 2020
First submitted: 25 Oct 2016
Last updated: 10 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Randomized Crossover Study, in Healthy Adult Subjects to Assess the Relative Oral Bioavailability of a Single 500-mg Dose of JNJ-53718678 Administered as (an) Oral Concept Formulation(s) Compared to the Current Oral Solution and to Assess the Effect of Food on the Pharmacokinetics of (an) Oral Concept Formulation(s)
ClinicalTrials.gov ID: NCT02945007
Acronym / sponsor ID: CR108212
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 8 Nov 2016 (actual)
Primary completion: 16 Jan 2020 (actual)
Study completion: 16 Jan 2020 (actual)
First posted: 26 Oct 2016 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
JNJ-53718678: PART 1	Experimental	Drug: JNJ-53718678Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and B (novel concept formulation 1), and under fed condition for treatment C (novel concept formulation 1).
JNJ-53718678: PART 2	Experimental	Drug: JNJ-53718678Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and D (novel concept formulation 2), and under fed condition for treatment E (novel concept formulation 2). Part 2 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.
JNJ-53718678: PART 3	Experimental	Drug: JNJ-53718678Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and F (novel concept formulation 3), and under fed condition for treatment G (novel concept formulation 3). Part 3 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.
JNJ-53718678: PART 4	Experimental	Drug: JNJ-53718678Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and H (novel concept formulation 4), and under fed condition for treatment I (novel concept formulation 4). Part 4 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.
JNJ-53718678: PART 5	Experimental	Drug: JNJ-53718678Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and J (novel concept formulation 5), and under fed condition for treatment K (novel concept formulation 5). Part 5 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.
JNJ-53718678: PART 6	Experimental	Drug: JNJ-53718678Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and L (novel concept formulation 6), and under fed condition for treatment M (novel concept formulation 6). Part 6 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.
JNJ-53718678: PART 7	Experimental	Drug: JNJ-53718678Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and N (novel concept formulation 7), and under fed condition for treatment O (novel concept formulation 7). Part 7 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.
JNJ-53718678: PART 8	Experimental	Drug: JNJ-53718678Participants will receive a single dose of JNJ-53718678, 500 mg oral solution under fasted or fed conditions on day 1 for treatment A and P (oral concept formulation 1, 2, 3, 4, 5, 6 or 7) and under fed conditions for treatment Q (oral concept formulation 1, 2, 3, 4, 5, 6 or 7). Part 8 of the study is optional, might be performed, depending on the interim results of prior parts. One of the concept formulations might be re-evaluated under different feeding conditions.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

At Screening, a female participant must be of non-childbearing potential as defined in the protocol
Female participants must have a negative serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at Screening
A male participant must be sexually abstinent (defined as refraining from sexual intercourse from Day 1 (day of dosing) until 90 days after study drug intake) or who is sexually active (either heterosexual, including with a pregnant woman, or homosexual) must agree to use a barrier method of contraception (example, condom) from Day 1 (day of dosing) until 90 days after study drug intake
Participant must have a body mass index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter^2 (kg/m2), extremes included
Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic

Key exclusion criteria (5 listed)

Participant with a 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 insufficiency, renal dysfunction (calculated creatinine clearance below 60 milliliter per minute (mL/min) at Screening using the Cockroft-Gault equation), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers that it could interfere with the interpretation of the study results should exclude the participant
Participants with abnormal values for either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (greater than or equal to [>=]1.25 x upper limit of laboratory normal range [ULN])
Participants with lack of good/reasonable venous access
Participants with a past history of heart arrhythmias (extrasystoli, tachycardia at rest) or, history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
Participants with a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) criteria within 5 years before Screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, methadone, benzodiazepines, and hallucinogens) at Screening and on Day -1 of each treatment period

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-53718678Participants will receive JNJ-53718678 under fed or fasted conditions.	Drug	JNJ-53718678: PART 1, JNJ-53718678: PART 2, JNJ-53718678: PART 3, JNJ-53718678: PART 4, JNJ-53718678: PART 5, JNJ-53718678: PART 6, JNJ-53718678: PART 7, JNJ-53718678: PART 8

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678
Time frame: Up to 72 hour of Post-dose
The Cmax is the maximum observed plasma concentration.
Area Under the Plasma ConcentrationTime Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0last]) of JNJ-53718678
Time frame: Up to 72 hour of Post-dose
The AUC (0-last) is the area under the plasma concentration time curve from time 0 to the time of the last measurable non-below quantification limit concentration, calculated by liner-linear trapezoidal summation.
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-53718678
Time frame: Up to 72 hour of 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.
Relative Bioavailability of JNJ-53718678
Time frame: Up to 72 hour of Post-dose
The relative bioavailability based on Cmax, AUC(0last), and AUC(0-inf) will be estimated as 100*Test/Reference, where Test is defined as the pharmacokinetic parameters of oral JNJ-53718678 and Reference is defined as currently existing oral solution G024.
Effect of Food on the Bioavailabilty of JNJ-53718678
Time frame: Up to 72 hour of Post-dose
The effect of food will be evaluated by comparing the pharmacokinetics of JNJ-53718678 under fed conditions with the currently existing oral solution under fasted conditions.

1 secondary outcome

Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability
Time frame: Up to 35 days after last study drug intake

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 10 Mar 2020.
To learn how to participate in this trial please click here.Link provided by the sponsor.

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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-53718678 in people with Healthy, run by Janssen Research & Development, LLC 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 10 Mar 2020. 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 Concentration (Cmax) of JNJ-53718678 (time frame: Up to 72 hour of Post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02945007.

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 10 Mar 2020.