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出境医 / 临床实验 / A Study to Assess the Relative Oral Bioavailability and Food Effect of Single-dose of JNJ-64417184 in Healthy Participants
A Study to Assess the Relative Oral Bioavailability and Food Effect of Single-dose of JNJ-64417184 in Healthy Participants
Study Description
Brief Summary:
The main purpose of this study is to evaluate the relative bioavailability of JNJ-64417184, formulated as a test formulation (tablet) compared to a reference formulation (suspension), administered orally in a fasted state, in healthy participants.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy | Drug: JNJ-64417184 600 (Oral Tablet Formulation) Drug: JNJ-64417184 (Oral Suspension Formulation) | Phase 1 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 18 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | A Phase 1 Open-label Study in Healthy Subjects to Assess the Relative Oral Bioavailability and Food Effect of Single-dose JNJ-64417184 Administered as Tablets and as Suspension |
| Actual Study Start Date : | May 15, 2019 |
| Actual Primary Completion Date : | June 22, 2019 |
| Actual Study Completion Date : | June 22, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Group 1: JNJ-64417184
Participants will receive JNJ-64417184 600 milligram (mg) oral tablet under fasted conditions on Day 1 in Treatment Period 1; followed by JNJ-64417184 600 mg oral tablet in fed conditions on Day 8 in Treatment Period 2; followed by JNJ-64417184 600 mg as oral suspension in fasted condition on Day 15 in Treatment Period 3. A washout period of at least 7 days will be maintained between each treatment period.
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Drug: JNJ-64417184 600 (Oral Tablet Formulation)
Participants will receive 600 mg of JNJ-64417184 as oral tablet.
Drug: JNJ-64417184 (Oral Suspension Formulation) Participants will also receive JNJ-64417184 600 mg as oral suspension.
|
|
Experimental: Group 2: JNJ-64417184
Participants will receive JNJ-64417184 600 mg oral tablet under fed conditions on Day 1 in Treatment Period 1; followed by JNJ-64417184 600 mg as oral suspension in fasted conditions on Day 8 in Treatment Period 2; followed by JNJ-64417184 600 mg tablet under fasted conditions on Day 15 in Treatment Period 3. A washout period of at least 7 days will be maintained between each treatment period.
|
Drug: JNJ-64417184 600 (Oral Tablet Formulation)
Participants will receive 600 mg of JNJ-64417184 as oral tablet.
Drug: JNJ-64417184 (Oral Suspension Formulation) Participants will also receive JNJ-64417184 600 mg as oral suspension.
|
|
Experimental: Group 3: JNJ-64417184
Participants will receive JNJ-64417184 600 mg as oral suspension in fasted conditions on Day 1 in Treatment Period 1; followed by JNJ-64417184 600 mg tablet under fasted conditions on Day 8 in Treatment Period 2; followed by JNJ-64417184 600 mg tablet under fed conditions on Day 15 in Treatment Period 3. A washout period of at least 7 days will be maintained between each treatment period.
|
Drug: JNJ-64417184 600 (Oral Tablet Formulation)
Participants will receive 600 mg of JNJ-64417184 as oral tablet.
Drug: JNJ-64417184 (Oral Suspension Formulation) Participants will also receive JNJ-64417184 600 mg as oral suspension.
|
|
Experimental: Group 4: JNJ-64417184
Participants will receive JNJ-64417184 600 mg tablet under fasted conditions on Day 1 in Treatment Period 1; followed by JNJ-64417184 600 mg as oral suspension in fasted conditions on Day 8 in Treatment Period 2; followed by JNJ-64417184 600 mg tablet under fed conditions on Day 15 in Treatment Period 3. A washout period of at least 7 days will be maintained between each treatment period.
|
Drug: JNJ-64417184 600 (Oral Tablet Formulation)
Participants will receive 600 mg of JNJ-64417184 as oral tablet.
Drug: JNJ-64417184 (Oral Suspension Formulation) Participants will also receive JNJ-64417184 600 mg as oral suspension.
|
|
Experimental: Group 5: JNJ-64417184
Participants will receive JNJ-64417184 600 mg tablet under fed conditions on Day 1 in Treatment Period 1; followed by JNJ-64417184 600 mg tablet under fasted conditions on Day 8 in Treatment Period 2; followed by JNJ-64417184 600 mg as oral suspension in fasted conditions on Day 15 in Treatment Period 3. A washout period of at least 7 days will be maintained between each treatment period.
|
Drug: JNJ-64417184 600 (Oral Tablet Formulation)
Participants will receive 600 mg of JNJ-64417184 as oral tablet.
Drug: JNJ-64417184 (Oral Suspension Formulation) Participants will also receive JNJ-64417184 600 mg as oral suspension.
|
|
Experimental: Group 6: JNJ-64417184
Participants will receive JNJ-64417184 600 mg as oral suspension in fasted conditions on Day 1 in Treatment Period 1; followed by JNJ-64417184 600 mg tablet under fed conditions on Day 8 in Treatment Period 2; followed by JNJ-64417184 600 mg tablet under fasted conditions on Day 15 in Treatment Period 3. A washout period of at least 7 days will be maintained between each treatment period.
|
Drug: JNJ-64417184 600 (Oral Tablet Formulation)
Participants will receive 600 mg of JNJ-64417184 as oral tablet.
Drug: JNJ-64417184 (Oral Suspension Formulation) Participants will also receive JNJ-64417184 600 mg as oral suspension.
|
Outcome Measures
Primary Outcome Measures :
- Relative Bioavailability of JNJ-64417184 [ Time Frame: Day 1,8,15:Predose, 0.5,1,2,3,4,6,8,10,12 and 18 hours (hrs) postdose; Day 2,9,16:24,36hrs postdose; Day 3,10,17:48 hrs postdose; Day 4,11,18:72hrs postdose; Day 5,12,19:96hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21 ]The relative bioavailability based on Cmax, AUC(0last), and AUC(0-infinity) will be estimated as 100*Test/Reference where Test is tablet formulation of JNJ-64417184 and Reference is suspension formulation of JNJ-64417184 administered orally in a fasted state.
Secondary Outcome Measures :
- Plasma Concentration of JNJ-64417184 in Fasted Conditions [ Time Frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21 ]Plasma concentration of JNJ-64417184 will be determined when administered as suspension under fasted conditions.
- Plasma Concentration of JNJ-64417184 in fed and Fasted Conditions [ Time Frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21 ]Plasma concentration of JNJ-64417184 will be determined when administered as tablet under fed and fasted conditions.
- Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184 in fed State [ Time Frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21 ]Cmax is defined as maximum observed plasma analyte concentration of JNJ-64417184 in fed state.
- Area Under the Plasma Analyte Concentration- time Curve from time 0 to time of the last Quantifiable Concentration (AUC [0-last]) in fed State [ Time Frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21 ]AUC (0-last) is defined as area under the plasma analyte concentration- time curve (AUC) from time 0 to time of the last quantifiable concentration of JNJ-64417184 in fed state.
- Area Under the Plasma Analyte Concentration-time Curve From time 0 to Infinite time (AUC [0-infinity]) in fed State [ Time Frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21 ]AUC (0-infinity) is defined as area under the plasma analyte concentration-time curve (AUC) from time 0 to infinite time of JNJ-64417184 in fed state.
- Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184 in Fasted State [ Time Frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21 ]Cmax is defined as maximum observed plasma analyte concentration of JNJ-64417184 in fasted state.
- Area Under the Plasma Analyte Concentration- time Curve from time 0 to time of the last (AUC [0-last]) Quantifiable Concentration in Fasted State [ Time Frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21 ]AUC (0-last) is defined as area under the plasma analyte concentration- time curve (AUC) from time 0 to time of the last quantifiable concentration of JNJ-64417184 in fasted state.
- Area Under the Plasma Analyte Concentration-time Curve From time 0 to Infinite time (AUC [0-infinity]) in Fasted State [ Time Frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21 ]AUC (0-infinity) is defined as area under the plasma analyte concentration-time curve (AUC) from time 0 to infinite time of JNJ-64417184 in fasted state.
- Number of Participants with Adverse Event as Measure of Safety and Tolerability [ Time Frame: Approximately 21 Days ]An adverse event is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy on the basis of physical examination, medical and surgical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Healthy on the basis of clinical laboratory tests performed at screening. If the results of the hematology, biochemistry, blood coagulation, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Must have a normal 12-lead electrocardiogram (ECG) (triplicate) at screening, including: normal sinus rhythm (heart rate between 45 and 100 beats per minute [bpm], extremes included); QT interval corrected for heart rate (QTc) according to Fridericia (QTcF) less than or equal to (<=) 450 milli second (ms) for male participants and <=470 ms for female participants; QRS interval less than (<) 120 ms; PR interval <=200 ms. If the results of the ECG are outside the normal ranges, the participant may be included only if the investigator judges the deviations from normal ECG to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Female participant must have a negative highly sensitive serum beta human chorionic gonadotropin (beta hCG) pregnancy test at screening and on Days -1, 7, and 14 (except for postmenopausal female participants)
- Female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 90 days after the last study drug intake
Exclusion Criteria:
- Past history of cardiac arrhythmias (example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
- Current human immunodeficiency virus (HIV)-type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
- History of hepatitis A, B, or C infection, or current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen), or hepatitis C virus (HCV) infection (confirmed by HCV antibody) at screening
- A history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
- Known allergies, hypersensitivity, or intolerance to JNJ-64417184 or any of its excipients
Contacts and Locations
Locations
| United States, Utah | |
| PRA Health Sciences Salt Lake City Clinic | |
| Salt Lake City, Utah, United States, 84124 | |
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 15, 2019 | ||||||
| First Posted Date ICMJE | May 16, 2019 | ||||||
| Last Update Posted Date | May 20, 2020 | ||||||
| Actual Study Start Date ICMJE | May 15, 2019 | ||||||
| Actual Primary Completion Date | June 22, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Relative Bioavailability of JNJ-64417184 [ Time Frame: Day 1,8,15:Predose, 0.5,1,2,3,4,6,8,10,12 and 18 hours (hrs) postdose; Day 2,9,16:24,36hrs postdose; Day 3,10,17:48 hrs postdose; Day 4,11,18:72hrs postdose; Day 5,12,19:96hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21 ] The relative bioavailability based on Cmax, AUC(0last), and AUC(0-infinity) will be estimated as 100*Test/Reference where Test is tablet formulation of JNJ-64417184 and Reference is suspension formulation of JNJ-64417184 administered orally in a fasted state.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | A Study to Assess the Relative Oral Bioavailability and Food Effect of Single-dose of JNJ-64417184 in Healthy Participants | ||||||
| Official Title ICMJE | A Phase 1 Open-label Study in Healthy Subjects to Assess the Relative Oral Bioavailability and Food Effect of Single-dose JNJ-64417184 Administered as Tablets and as Suspension | ||||||
| Brief Summary | The main purpose of this study is to evaluate the relative bioavailability of JNJ-64417184, formulated as a test formulation (tablet) compared to a reference formulation (suspension), administered orally in a fasted state, in healthy participants. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 1 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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| Condition ICMJE | Healthy | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
18 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | June 22, 2019 | ||||||
| Actual Primary Completion Date | June 22, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 55 Years (Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03952507 | ||||||
| Other Study ID Numbers ICMJE | CR108632 64417184RSV1001 ( Other Identifier: Janssen Research & Development, LLC ) |
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| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Janssen Research & Development, LLC | ||||||
| Study Sponsor ICMJE | Janssen Research & Development, LLC | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Janssen Research & Development, LLC | ||||||
| Verification Date | May 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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