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Influenza A VirusPhase 1NCT02659735

A Study to Assess the Relative Oral Bioavailability of JNJ-63623872 Administered as Oral Concept Formulations Compared to the Current Tablet Formulation

A Phase 1 study testing JNJ-63623872 300 milligram (mg) and JNJ-63623872 600 mg in people with Influenza A Virus, 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 compare the rate and extent of absorption of JNJ-63623872 following administration of a single dose as three different concept formulations with that following administration of the current formulation, under both fed and fasted conditions, in healthy adult participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Influenza A Virus
What is being tested?
JNJ-63623872 300 milligram (mg) and JNJ-63623872 600 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteBelgium
Study dates
Dec 2015to Apr 2016
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

  • A female participants must be either: a) 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 6 months and a serum follicle stimulating hormone (FSH) level >40 international Unit/Liter (IU/L); OR b) Permanently sterilized (example, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or otherwise incapable of becoming pregnant; OR c) If of childbearing potential and heterosexually active, be practicing an effective method of contraception before entry and agree to continue to use two effective methods of contraception throughout the study and for at least 90 days after receiving the last dose of study drug
  • A female participant (except if postmenopausal) must have a negative serum beta human chorionic gonadotropin (beta hCG) pregnancy test at Screening and on Day -1
  • Participants must have a Body Mass Index (BMI) between 18.0 and 30.0 kilogram per meter^2 (kg/m^2) (extremes included)
  • Participants must have a blood pressure (after the participant is supine for at least 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at Screening
  • Participants must be non-smokers for at least 3 months prior to Screening

Who cannot join

  • Participant has a history of 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
  • Participant with a past history of heart arrhythmias (extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
  • Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
  • Participant with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
  • Participant has taken any disallowed therapies before the planned first intake of study drug

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Study site

    Antwerp

Other trials in Belgium

About this study

Official title: A Phase 1, Open-label, 2-panel, Randomized, Crossover Study in Healthy Adult Subjects to Assess the Relative Oral Bioavailability of a Single 600-mg Dose of JNJ-63623872 Administered as Oral Concept Formulations Compared to the Current Tablet Formulation, Under Fed and Fasted Conditions

The purpose of this study is to compare the rate and extent of absorption of JNJ-63623872 following administration of a single dose as three different concept formulations with that following administration of the current formulation, under both fed and fasted conditions, in healthy adult participants.

Read the detailed description

This is a Phase 1, open-label, 2-panel, randomized, crossover study in healthy adult participants to assess the relative bioavailability JNJ-63623872. The study population will consist of 48 healthy adult participants, equally divided over 2 panels: 24 participants in Panel 1 and 24 participants in Panel 2. participants will be randomized within each panel. Participants will not be randomized between panels. Panels 1 and 2 will be performed sequentially. Participants having participated in one panel cannot also participate in the other panel. In Panel 1, during 4 subsequent treatment sessions (Periods I, II, III and IV), each participant will receive 4 treatments (Treatments A, B, C, and D), randomized according to a classical 4 sequence, 4 period Williams design. In Panel 2, during 3 subsequent treatment sessions (Periods I, II and III), each participant will receive 3 treatments (Treatments E, F, and G) randomized according to a classical 6 sequence, 3 period Williams design. Primarily, pharmacokinetic parameters will be evaluated. Participants' safety will be monitored throughout the study.

Being tested
JNJ-63623872 300 milligram (mg), JNJ-63623872 600 mg
Keywords
Influenza A virus, JNJ-63623872, Healthy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-63623872 300 milligram (mg)Drug

    Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.

  • JNJ-63623872 600 mgDrug

    Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.

  • JNJ-63623872 600 mgDrug

    Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1.

  • JNJ-63623872 600 mgDrug

    Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1.

Study groups in NCT02659735
Study groupRoleWhat they receive
Panel 1: Treatment ADBCExperimentalParticipants will receive Treatment A (600 milligram [mg] JNJ-63623872 formulated as the 300 mg oral tablet [reference] under fed conditions) in Period 1; followed by Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 [test 3] under fed conditions) in Period 2; followed by Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 [test 1] under fed conditions) in Period 3; followed by Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 [test 2] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period.
Receives: Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg
Panel 1: Treatment BACDExperimentalParticipants will receive Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 [test 1] under fed conditions) in Period 1; followed by Treatment A (600 mg JNJ-63623872 formulated as the 300 mg oral tablet [reference] under fed conditions) in Period 2; followed by Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 [test 2] under fed conditions) in Period 3; followed by Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 [test 3] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period.
Receives: Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg
Panel I: Treatment CBDAExperimentalParticipants will receive Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 [test 2] under fed conditions) in Period 1; followed by Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 [test 1] under fed conditions) in Period 2; followed by Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 [test 3] under fed conditions) in Period 3; followed by Treatment A (600 mg JNJ-63623872 formulated as the 300 mg oral tablet [reference] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period.
Receives: Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg
Panel I: Treatment DCABExperimentalParticipants will receive Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 [test 3] under fed conditions) in Period 1; followed by Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 [test 2] under fed conditions) in Period 2; followed by Treatment A (600 mg JNJ-63623872 formulated as the 300 mg oral tablet [reference] under fed conditions) in Period 3; followed by Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 [test 1] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period.
Receives: Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg
Panel 2: Treatment EFGExperimentalParticipants will receive Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet [reference] under fasted conditions) in Period 1; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 [test 4] under fasted conditions) in Period 2; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 [test 5] under fed conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.
Receives: Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg
Panel 2: Treatment FGEExperimentalParticipants will receive Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 [test 4] under fasted conditions) in Period 1; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 [test 5] under fed conditions) in Period 2; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet [reference] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.
Receives: Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg
Panel 2: Treatment GEFExperimentalParticipants will receive Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 [test 5] under fed conditions) in Period 1; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet [reference] under fasted conditions) in Period 2; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 [test 4] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.
Receives: Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg
Panel 2: Treatment GFEExperimentalParticipants will receive Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 [test 5] under fed conditions) in Period 1; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 [test 4] under fasted conditions) in Period 2; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet [reference] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.
Receives: Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg
Panel 2: Treatment FEGExperimentalParticipants will receive Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 [test 4] under fasted conditions) in Period 1; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet [reference] under fasted conditions) in Period 2; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 [test 5] under fed conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.
Receives: Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg
Panel 2: Treatment EGFExperimentalParticipants will receive Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet [reference] under fasted conditions) in Period 1; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 [test 5] under fed conditions) in Period 2; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 [test 4] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.
Receives: Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg

What is being measured

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

  1. Maximum Observed Plasma Concentration (Cmax)

    The Cmax is the maximum observed plasma concentration.

    Measured: Day 1

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

    Measured: Day 1

  3. 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: Day 1

  4. 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: Day 1

  5. Elimination Rate Constant (Lambda[z])

    Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.

    Measured: Day 1

  6. Elimination Half-Life (t1/2)

    The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

    Measured: Day 1

Secondary outcomes (3)

  1. Number of Participants With Adverse Events

    An adverse event 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: Baseline up to 10 to 14 days after last study drug administration

  2. Taste Questionnaire Assessment

    Participants will answers a questionnaire on taste of the study drug. The questionnaire consists of 4 parts (sweetness, bitterness, flavour and overall); each parts is scored on 4 points , i.e. none, weak, moderate and strong.

    Measured: Day 1

  3. Swallowability Assessment

    Swallowability will be assessed on a scale of 1-7; how difficult/easy was it to swallow this tablet. In the scale 0=very difficult and 7=very easy.

    Measured: Day 1

Timeline

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

  1. First posted20 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

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
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02659735
Sponsor's protocol ID
CR108109
Other IDs
63623872FLZ1006, 2015-002299-26, 2015
Status last verified
Jan 2025
First submitted
7 Jan 2016
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-63623872 300 milligram (mg) and JNJ-63623872 600 mg in people with Influenza A Virus, 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 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 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) (time frame: Day 1). 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?

On the ClinicalTrials.gov record for NCT02659735.

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.

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