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| ID | Type | Description | Link |
|---|---|---|---|
| 63623872FLZ1006 | Other Identifier | Janssen Research & Development, LLC | |
| 2015-002299-26 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel 1: Treatment ADBC | Experimental | Participants 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. |
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| Panel 1: Treatment BACD | Experimental | Participants 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. |
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| Panel I: Treatment CBDA | Experimental | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-63623872 300 milligram (mg) | Drug | Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | The Cmax is the maximum observed plasma concentration. | Day 1 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Day 1 |
| 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. | Day 1 |
| 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. | Day 1 |
| 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. | Day 1 |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 10 to 14 days after last study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trials | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp | Belgium |
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| Panel I: Treatment DCAB | Experimental | Participants 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. |
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| Panel 2: Treatment EFG | Experimental | Participants 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. |
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| Panel 2: Treatment FGE | Experimental | Participants 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. |
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| Panel 2: Treatment GEF | Experimental | Participants 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. |
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| Panel 2: Treatment GFE | Experimental | Participants 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. |
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| Panel 2: Treatment FEG | Experimental | Participants 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. |
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| Panel 2: Treatment EGF | Experimental | Participants 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. |
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| JNJ-63623872 600 mg | Drug | Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1. |
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| JNJ-63623872 600 mg | Drug | Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1. |
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| JNJ-63623872 600 mg | Drug | Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1. |
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| Day 1 |
| 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. | Day 1 |
| 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. | Day 1 |
| ID | Term |
|---|---|
| C000605010 | pimodivir |
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