HealthyPhase 1NCT03403348
A First-In-Human Study of Orally Administered JNJ-64417184 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses, and the Antiviral Activity of Multiple Doses in a Respiratory Syncytial Virus (RSV) Challenge Study in Healthy Participants
A Phase 1 study testing JNJ-64417184 in people with Healthy, run by Janssen BioPharma, Inc. at 2 sites in United Kingdom.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of single and multiple oral doses of JNJ-64417184 administered to healthy participants and the antiviral effect of multiple oral doses of JNJ-64417184 compared to placebo in participants infected through inoculation with respiratory syncytial virus… 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-64417184
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 9 May 2018to 24 Nov 2019
- 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
- Participant has provided written consent
- In the Investigator's opinion, the participant is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned
- Participant is in good health as deemed by the Investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG). In case of an out-of-range clinical laboratory test, vital sign, or ECG value that will determine a participant's eligibility, a retest can be done. Results of this retest must be available prior to the first administration of the study drugs (Parts 1, 3, 5, and 6) or prior to inoculation (Part 4). The result of the retest will be considered for participant eligibility
- Body mass index (BMI) of 18 to 30 kilogram per meter square (kg/m^2) (inclusive), minimum weight of 50 kilogram (kg)
- A female participant is eligible to participate in this study if she is of non childbearing potential defined as either (i) premenopausal with a documented tubal ligation, bilateral oophorectomy, or hysterectomy; or (ii) postmenopausal defined by 12 months of spontaneous amenorrhea and follicle-stimulating hormone level within the laboratory's reference range for postmenopausal females. A postmenopausal female who is receiving hormone replacement therapy and who is willing to discontinue hormone therapy from 28 days before study drug dosing (Parts 1, 3, 5, and 6) or before inoculation (Part 4), and for the entire duration of the study, may be eligible for study participation. A male participant is eligible to participate in this study if (i) he is either surgically sterile or, (ii) in case of having a female partner of childbearing potential, the male participant and partner are practicing and willing to continue to practice highly effective forms of birth control until 90 days after the end of the study. Irrespective of the partner's form of birth control, a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person
Who cannot join
- Clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, endocrinologic, oncologic, ophthalmologic, musculoskeletal, psychiatric or any other uncontrolled medical illness
- Positive human immunodeficiency virus (HIV), active hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV) test
- Creatinine clearance less than (<) 60 milliliter per minute (mL/min) (Cockcroft-Gault)
- Drug allergy such as, but not limited to, allergy to penicillins, including allergies experienced in previous studies with experimental drugs
- Any condition that, in the opinion of the Investigator, would compromise the study or the well-being of the participant or prevent the participant from meeting the study requirements
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
hVIVO Services Limited
London, E1 2AX
Hammersmith Medicines Research Ltd
London, NW10 7EW
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 6-Part Study of Orally Administered JNJ-64417184 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses, and the Antiviral Activity of Multiple Doses in a Respiratory Syncytial Virus (RSV) Challenge Study in Healthy Subjects
The purpose of the study is to evaluate the safety and tolerability of single and multiple oral doses of JNJ-64417184 administered to healthy participants and the antiviral effect of multiple oral doses of JNJ-64417184 compared to placebo in participants infected through inoculation with respiratory syncytial virus (RSV)-A Memphis 37b (Part 4).
- Conditions
- Healthy
- Being tested
- JNJ-64417184, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-64417184Drug
Participants will receive JNJ-64417184 in Parts 1, 2A, 2B, 3, 4, 5 and 6.
PlaceboDrug
Participants will receive matching placebo to JNJ-64417184 in Parts 1, 2A, 2B, 3, 4, 5 and 6.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Participants will be enrolled in 7 cohorts and receive one of the 7 corresponding SADs of JNJ-64417184, starting from 40 milligram (mg), or placebo in a fasted state. Dose escalation in the subsequent cohorts will depend on the human maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) in previous cohorts. Receives: Drug: JNJ-64417184; Drug: Placebo |
| Part 2A: Food Effect | Experimental | Participants enrolled in cohort 4 of part 1 will roll-over in Part 2A and will receive a single oral dose (the same dose as received in Part 1) of JNJ-64417184 or placebo with a high-fat meal. Receives: Drug: JNJ-64417184; Drug: Placebo |
| Part 2B: Relative Bioavailability (Optional) | Experimental | Participants enrolled in cohorts 5, 6, 7 or any other optional cohorts of Part 1 will roll-over in Part 2B and will receive a single oral dose (the same dose as received in Part 1) of JNJ-64417184 or placebo under fasted state. Dosing may be changed from fasted to a fed state, depending on emerging pharmacokinetics (PK) data from Part 2A. Receives: Drug: JNJ-64417184; Drug: Placebo |
| Part 3: Multiple Ascending Dose (MAD) | Experimental | Participants will be enrolled in 3 cohorts and will receive one of the 3 corresponding MADs of JNJ-64417184 or placebo, dosed once daily for 7 days. There will be 3 optional cohorts and participants in these cohorts will follow 7- to 14-day dosing schedule. Dosing will either occur in the fasted or the fed state, depending on the outcome of Part 2A. Dose selection and dose escalation in the MAD cohorts will depend on the observed human Cmax and AUC in previous (SAD) cohorts. Additional cohorts may be evaluated at the discretion of the Sponsor and the Principal Investigator (PI). Receives: Drug: JNJ-64417184; Drug: Placebo |
| Part 4: Human RSV Challenge (Proof-of-Concept Study Part) | Experimental | Based on emerging PK and safety data from Part 3 (MAD), the participants inoculated with respiratory syncytial virus (RSV) -A Memphis 37b and confirmed positive by polymerase chain reaction (PCR) will either receive JNJ-64417184 or placebo once daily OR receive JNJ-64417184 (low dose), JNJ-64417184 (high dose) or placebo once daily. Receives: Drug: JNJ-64417184; Drug: Placebo |
| Part 5: SAD/Japanese | Experimental | Participants of Japanese descent will be enrolled in 3 cohorts and will receive one of the corresponding SADs of JNJ-64417184 or placebo in a fasted state. Dosing may be changed from fasted to a fed state, depending on emerging PK data from Part 2A. The starting dose and formulation will be selected based on the outcome of Parts 1 and 2. Dose escalation in the subsequent cohorts will depend on the observed human Cmax and AUC in previous cohorts. Receives: Drug: JNJ-64417184; Drug: Placebo |
| Part 6: MAD/Japanese (Optional) | Experimental | Participants of Japanese descent may be enrolled in 3 cohorts and will receive one of the corresponding MADs of JNJ-64417184 or placebo, dosed once daily for 7 to 14 days. Dosing will either occur in the fasted or the fed state, depending on the outcome of Part 2A. Dose selection and dose escalation in the MAD cohorts will depend on the observed human Cmax and AUC in previous (Parts 1, 2, 3, and 5) cohorts. Receives: Drug: JNJ-64417184; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: Approximately up to 8 months
Number of Participants With Laboratory Abnormalities
Number of participants with laboratory abnormalities will be reported.
Measured: Approximately up to 8 months
Number of Participants With Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in vital signs will be reported.
Measured: Approximately up to 8 months
Number of Participants With Clinically Significant Changes in Physical Examination Findings
Number of participants with clinically significant changes in physical examination findings will be reported.
Measured: Approximately up to 8 months
Number of Participants With ECG Abnormalities
Number of participants with electrocardiogram (ECG) abnormalities will be reported.
Measured: Approximately up to 8 months
Change From Baseline in QT Interval Corrected According to Fridericia's Formula (QTcF) (Parts 1 and 3)
The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiograms (ECG) triplicates.
Measured: Baseline up to Day 31
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Absolute as Measured by Spirometry (Part 4)
FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in absolute FEV1 indicates improvement in lung function.
Measured: Baseline up to Day 31
Change From Baseline in Forced Vital Capacity (FVC) Absolute as Measured by Spirometry (Part 4)
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, in liters and will be measured by spirometry.
Measured: Baseline up to Day 31
Change From Baseline in Percent-Predicted FEV1 (Part 4)
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests will be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100 percent (%).
Measured: Baseline up to Day 31
Change From Baseline in Percent-Predicted FVC (Part 4)
Predicted FVC is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100 %.
Measured: Baseline up to Day 31
Area Under the Concentration-Time Curve Between Time of First Administration and Dosing Day 7 (AUC[0-Dosing Day 7]) of RSV-A Memphis 37b Viral Load in Participants Infected Through Inoculation With This Viral Strain (Part 4)
Area under the concentration-time curve between time of first administration and Dosing Day 7 (AUC[0-Dosing Day 7)] of respiratory syncytial virus (RSV)-A Memphis 37b viral load in participants infected through inoculation with this viral strain, as determined by a quantitative real-time polymerase chain reaction (qRT PCR) assay of nasal wash (Part 4) will be assessed.
Measured: Up to Day 7
Secondary outcomes (9)
JNJ-64417184 Plasma Concentrations
Plasma concentration of JNJ-64417184 after a single oral dose and after multiple oral doses will be assessed.
Measured: Approximately up to 67 days
JNJ-64417184 Urine Concentrations
Urine concentration of JNJ-64417184 after a single oral dose and after multiple oral doses will be assessed.
Measured: Approximately up to 67 days
Corrected QT Interval (QTc) Duration (Parts 1 and 3)
QTc duration (as calculated from Holter extracts) after a single oral dose and after multiple oral doses administered to healthy participants will be reported.
Measured: Up to Day 2 (Part 1); Up to Day 8 (Part 3)
AUC(0-Dosing Day 7) of RSV Viral Load From Treatment Onset (Part 4)
The AUC(0-Dosing Day 7) of RSV viral load from treatment onset, as determined by a qRT-PCR assay of nasal wash samples and by cell culture (plaque assay) will be reported.
Measured: Up to Day 7
Time to Non-Detectability of RSV (Part 4)
Time to non-detectability of RSV as determined by a qRT-PCR assay of nasal wash samples and by cell culture (plaque assay) will be reported.
Measured: Up to Day 31
Peak RSV Viral Load by Dosing Day (Part 4)
Peak RSV viral load by dosing day as determined by a qRT-PCR assay of nasal wash samples and by cell culture (plaque assay) will be reported.
Measured: Up to Day 31
AUC(0-Dosing Day 7) of Total RSV Symptoms From Treatment Onset
The AUC(0-Dosing Day 7) of total RSV symptoms from treatment onset, using self reported symptoms on the symptom diary card (SDC) will be reported. Participants will assess any challenge virus-related symptoms using the symptom questionnaire in the SDC which will report the symptoms experienced by the participants at the moment on a scale of 0 to 3 where '0' implies 'no symptom' and '3' implies 'bothersome most or all of the time, stopping from participating in activities' OR 'less severe' to 'more severe' symptoms.
Measured: Up to Day 7
Total Weight of Mucus (Part 4)
The total weight of mucus produced from treatment onset will be reported.
Measured: Up to Day 12
Change From Baseline in the RSV L Protein-Encoding Gene Sequence After Treatment (Part 4)
Change from baseline in sequence of the RSV L protein encoding gene before and after treatment, for participants who show rebound, partial viral suppression or non-response to JNJ-64417184, will be assessed.
Measured: Baseline up to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start9 May 2018
- Primary completion24 Nov 2019
- Study completion24 Nov 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Biopharma, Inc. Clinical Trial, Study director, Janssen BioPharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403348
- Sponsor's protocol ID
- JNJ-184-1401
- Other IDs
- 2017-004363-13, JNJ-184-1401, 2017
- Status last verified
- Jan 2020
- First submitted
- 21 Dec 2017
- Last updated
- 29 Jan 2020
- 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 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, First-in-human, 6-Part Study of Orally Administered JNJ-64417184 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses, and the Antiviral Activity of Multiple Doses in a Respiratory Syncytial Virus (RSV) Challenge Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03403348
- Acronym / sponsor ID
- JNJ-184-1401
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Janssen BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 May 2018 (actual)
- Primary completion
- 24 Nov 2019 (actual)
- Study completion
- 24 Nov 2019 (actual)
- First posted
- 18 Jan 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 purpose of the study is to evaluate the safety and tolerability of single and multiple oral doses of JNJ-64417184 administered to healthy participants and the antiviral effect of multiple oral doses of JNJ-64417184 compared to placebo in participants infected through inoculation with respiratory syncytial virus (RSV)-A Memphis 37b (Part 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Drug: JNJ-64417184, Drug: PlaceboParticipants will be enrolled in 7 cohorts and receive one of the 7 corresponding SADs of JNJ-64417184, starting from 40 milligram (mg), or placebo in a fasted state. Dose escalation in the subsequent cohorts will depend on the human maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) in previous cohorts. |
| Part 2A: Food Effect | Experimental | Drug: JNJ-64417184, Drug: PlaceboParticipants enrolled in cohort 4 of part 1 will roll-over in Part 2A and will receive a single oral dose (the same dose as received in Part 1) of JNJ-64417184 or placebo with a high-fat meal. |
| Part 2B: Relative Bioavailability (Optional) | Experimental | Drug: JNJ-64417184, Drug: PlaceboParticipants enrolled in cohorts 5, 6, 7 or any other optional cohorts of Part 1 will roll-over in Part 2B and will receive a single oral dose (the same dose as received in Part 1) of JNJ-64417184 or placebo under fasted state. Dosing may be changed from fasted to a fed state, depending on emerging pharmacokinetics (PK) data from Part 2A. |
| Part 3: Multiple Ascending Dose (MAD) | Experimental | Drug: JNJ-64417184, Drug: PlaceboParticipants will be enrolled in 3 cohorts and will receive one of the 3 corresponding MADs of JNJ-64417184 or placebo, dosed once daily for 7 days. There will be 3 optional cohorts and participants in these cohorts will follow 7- to 14-day dosing schedule. Dosing will either occur in the fasted or the fed state, depending on the outcome of Part 2A. Dose selection and dose escalation in the MAD cohorts will depend on the observed human Cmax and AUC in previous (SAD) cohorts. Additional cohorts may be evaluated at the discretion of the Sponsor and the Principal Investigator (PI). |
| Part 4: Human RSV Challenge (Proof-of-Concept Study Part) | Experimental | Drug: JNJ-64417184, Drug: PlaceboBased on emerging PK and safety data from Part 3 (MAD), the participants inoculated with respiratory syncytial virus (RSV) -A Memphis 37b and confirmed positive by polymerase chain reaction (PCR) will either receive JNJ-64417184 or placebo once daily OR receive JNJ-64417184 (low dose), JNJ-64417184 (high dose) or placebo once daily. |
| Part 5: SAD/Japanese | Experimental | Drug: JNJ-64417184, Drug: PlaceboParticipants of Japanese descent will be enrolled in 3 cohorts and will receive one of the corresponding SADs of JNJ-64417184 or placebo in a fasted state. Dosing may be changed from fasted to a fed state, depending on emerging PK data from Part 2A. The starting dose and formulation will be selected based on the outcome of Parts 1 and 2. Dose escalation in the subsequent cohorts will depend on the observed human Cmax and AUC in previous cohorts. |
| Part 6: MAD/Japanese (Optional) | Experimental | Drug: JNJ-64417184, Drug: PlaceboParticipants of Japanese descent may be enrolled in 3 cohorts and will receive one of the corresponding MADs of JNJ-64417184 or placebo, dosed once daily for 7 to 14 days. Dosing will either occur in the fasted or the fed state, depending on the outcome of Part 2A. Dose selection and dose escalation in the MAD cohorts will depend on the observed human Cmax and AUC in previous (Parts 1, 2, 3, and 5) cohorts. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant has provided written consent
- In the Investigator's opinion, the participant is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned
- Participant is in good health as deemed by the Investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG). In case of an out-of-range clinical laboratory test, vital sign, or ECG value that will determine a participant's eligibility, a retest can be done. Results of this retest must be available prior to the first administration of the study drugs (Parts 1, 3, 5, and 6) or prior to inoculation (Part 4). The result of the retest will be considered for participant eligibility
- Body mass index (BMI) of 18 to 30 kilogram per meter square (kg/m^2) (inclusive), minimum weight of 50 kilogram (kg)
- A female participant is eligible to participate in this study if she is of non childbearing potential defined as either (i) premenopausal with a documented tubal ligation, bilateral oophorectomy, or hysterectomy; or (ii) postmenopausal defined by 12 months of spontaneous amenorrhea and follicle-stimulating hormone level within the laboratory's reference range for postmenopausal females. A postmenopausal female who is receiving hormone replacement therapy and who is willing to discontinue hormone therapy from 28 days before study drug dosing (Parts 1, 3, 5, and 6) or before inoculation (Part 4), and for the entire duration of the study, may be eligible for study participation. A male participant is eligible to participate in this study if (i) he is either surgically sterile or, (ii) in case of having a female partner of childbearing potential, the male participant and partner are practicing and willing to continue to practice highly effective forms of birth control until 90 days after the end of the study. Irrespective of the partner's form of birth control, a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person
Key exclusion criteria (5 listed)
- Clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, endocrinologic, oncologic, ophthalmologic, musculoskeletal, psychiatric or any other uncontrolled medical illness
- Positive human immunodeficiency virus (HIV), active hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV) test
- Creatinine clearance less than (<) 60 milliliter per minute (mL/min) (Cockcroft-Gault)
- Drug allergy such as, but not limited to, allergy to penicillins, including allergies experienced in previous studies with experimental drugs
- Any condition that, in the opinion of the Investigator, would compromise the study or the well-being of the participant or prevent the participant from meeting the study requirements
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-64417184Participants will receive JNJ-64417184 in Parts 1, 2A, 2B, 3, 4, 5 and 6. | Drug | Part 1: Single Ascending Dose (SAD), Part 2A: Food Effect, Part 2B: Relative Bioavailability (Optional), Part 3: Multiple Ascending Dose (MAD), Part 4: Human RSV Challenge (Proof-of-Concept Study Part), Part 5: SAD/Japanese, Part 6: MAD/Japanese (Optional) |
| PlaceboParticipants will receive matching placebo to JNJ-64417184 in Parts 1, 2A, 2B, 3, 4, 5 and 6. | Drug | Part 1: Single Ascending Dose (SAD), Part 2A: Food Effect, Part 2B: Relative Bioavailability (Optional), Part 3: Multiple Ascending Dose (MAD), Part 4: Human RSV Challenge (Proof-of-Concept Study Part), Part 5: SAD/Japanese, Part 6: MAD/Japanese (Optional) |
Primary outcome
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Approximately up to 8 months
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Number of Participants With Laboratory Abnormalities
Time frame: Approximately up to 8 months
Number of participants with laboratory abnormalities will be reported.
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Approximately up to 8 months
Number of participants with clinically significant changes in vital signs will be reported.
Number of Participants With Clinically Significant Changes in Physical Examination Findings
Time frame: Approximately up to 8 months
Number of participants with clinically significant changes in physical examination findings will be reported.
Number of Participants With ECG Abnormalities
Time frame: Approximately up to 8 months
Number of participants with electrocardiogram (ECG) abnormalities will be reported.
Change From Baseline in QT Interval Corrected According to Fridericia's Formula (QTcF) (Parts 1 and 3)
Time frame: Baseline up to Day 31
The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiograms (ECG) triplicates.
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Absolute as Measured by Spirometry (Part 4)
Time frame: Baseline up to Day 31
FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in absolute FEV1 indicates improvement in lung function.
Change From Baseline in Forced Vital Capacity (FVC) Absolute as Measured by Spirometry (Part 4)
Time frame: Baseline up to Day 31
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, in liters and will be measured by spirometry.
Change From Baseline in Percent-Predicted FEV1 (Part 4)
Time frame: Baseline up to Day 31
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests will be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100 percent (%).
Change From Baseline in Percent-Predicted FVC (Part 4)
Time frame: Baseline up to Day 31
Predicted FVC is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100 %.
Area Under the Concentration-Time Curve Between Time of First Administration and Dosing Day 7 (AUC[0-Dosing Day 7]) of RSV-A Memphis 37b Viral Load in Participants Infected Through Inoculation With This Viral Strain (Part 4)
Time frame: Up to Day 7
Area under the concentration-time curve between time of first administration and Dosing Day 7 (AUC[0-Dosing Day 7)] of respiratory syncytial virus (RSV)-A Memphis 37b viral load in participants infected through inoculation with this viral strain, as determined by a quantitative real-time polymerase chain reaction (qRT PCR) assay of nasal wash (Part 4) will be assessed.
9 secondary outcomes
JNJ-64417184 Plasma Concentrations
Time frame: Approximately up to 67 days
JNJ-64417184 Urine Concentrations
Time frame: Approximately up to 67 days
Corrected QT Interval (QTc) Duration (Parts 1 and 3)
Time frame: Up to Day 2 (Part 1); Up to Day 8 (Part 3)
AUC(0-Dosing Day 7) of RSV Viral Load From Treatment Onset (Part 4)
Time frame: Up to Day 7
Time to Non-Detectability of RSV (Part 4)
Time frame: Up to Day 31
Peak RSV Viral Load by Dosing Day (Part 4)
Time frame: Up to Day 31
AUC(0-Dosing Day 7) of Total RSV Symptoms From Treatment Onset
Time frame: Up to Day 7
Total Weight of Mucus (Part 4)
Time frame: Up to Day 12
Change From Baseline in the RSV L Protein-Encoding Gene Sequence After Treatment (Part 4)
Time frame: Baseline up to Day 11
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 Jan 2020.
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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 Biopharma, Inc. Clinical Trial study director
Janssen BioPharma, Inc.
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 JNJ-64417184 in people with Healthy, run by Janssen BioPharma, Inc. at 2 sites in United Kingdom.
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 Jan 2020. 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 United Kingdom. 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?
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability (time frame: Approximately up to 8 months). The study lists 11 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 Jan 2020.