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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004832-12 | EudraCT Number | ||
| 64041575RSV1010 | Other Identifier | Janssen Research & Development, LLC |
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The study has been terminated due to pending data analysis
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The main purpose of study is to evaluate the effect of multiple-dose administration of lansoprazole (and optional: time-separated single dose administration of ranitidine) on the pharmacokinetics (PK) of JNJ-63549109 after a single dose of lumicitabine in healthy adult participants, under fasted (and optional: fed) conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Treatment Sequence (ABC) | Experimental | Participants will receive Treatment A as a single oral dose of 1000 milligram (mg) lumicitabine (4*250 mg tablets) under fasted condition on Day 1 of period 1 then Treatment B as a single oral dose of 30 mg lansoprazole under fasted condition on Days 1 to 4 and on Day 5 (administered 2 hours before a single oral dose of 1,000 mg lumicitabine) in period 2 followed by Treatment C (optional Part 2) as a single dose of 150 mg ranitidine administered after 2 hours of single dose of 1000 mg lumicitabine (4*250 mg tablets) under fasted condition on Day 1 of period 3. A washout period of at least 21 days will be maintained between each treatment period. |
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| Part 1: Treatment Sequence (BAC) | Experimental | Participants will receive Treatment B on Days 1 to 5 of period 1 then Treatment A on Day 1 of period 2 followed by Treatment C (optional Part 2) on Day 1 of period 3. A washout period of at least 21 days will be maintained between each treatment period. |
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| Optional Part 3: Treatment Sequence (DEF) | Experimental | Participants will receive Treatment D as a single oral dose of 1000 mg lumicitabine (4*250 mg tablets) after standardized breakfast on Day 1 of period 1 then Treatment E as a single oral dose of 30 mg lansoprazole under fasted condition on Days 1 to 4 and on Day 5 (administered 2 hours before a single oral dose of 1,000 mg lumicitabine) in period 2 followed by Treatment F as a single oral dose of 150 mg ranitidine administered after 2 hours after a single oral dose of 1000 mg lumicitabine (4*250 mg tablets) after standardized breakfast on Day 1 of period 3. A washout period of at least 21 days will be maintained between each treatment period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumicitabine | Drug | Participants will receive single oral dose of 1000 mg lumicitabine as per assigned treatment sequence. |
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| Measure | Description | Time Frame |
|---|---|---|
| Observed Plasma Concentration at 12 Hours Post dose (C12h) of JNJ-63549109 (Metabolite of JNJ- 64041575) | C12h is observed plasma concentration at 12 hours post dose. | 12 hours postdose (Day 1) |
| Observed Plasma Concentration at 24 Hours Post dose (C24h) of JNJ-63549109 (Metabolite of JNJ- 64041575) | C24h is observed plasma concentration at 24 hours post dose. | 24 hours postdose (Day 2) |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of JNJ- 64041575) | Cmax is the maximum observed plasma concentration. | Predose, 15 minutes (min), 30 min, 1 hour (h), 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-63549109 (Metabolite of JNJ-64041575) | Tmax is the actual sampling time to reach maximum observed plasma concentration. | Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months) |
| Area Under Plasma Concentration Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of JNJ-63549109 (Metabolite of JNJ-64041575) | Area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit [non BQL]) concentration, calculated by linear trapezoidal summation. | Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Plasma Concentration at 12 Hours Post dose (C12h) of JNJ-64167896 (Metabolite of JNJ- 64041575) | C12h is observed plasma concentration at 12 hours post dose. | 12 hours postdose (Day 1) |
| Observed Plasma Concentration at 24 Hours Post dose (C24h) of JNJ-64167896 (Metabolite of JNJ- 64041575) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
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| Optional Part 3: Treatment Sequence (EFD) | Experimental | Participants will receive Treatment E on Days 1 to 5 of period 1 then Treatment F on Day 1 of period 2 followed by Treatment D on Day 1 of period 3. A washout period of at least 21 days will be maintained between each treatment period. |
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| Optional Part 3: Treatment Sequence (FDE) | Experimental | Participants will receive Treatment F on Days 1 of period 1 then Treatment D on Day 1 of period 2 followed by Treatment E on Days 1 to 5 of period 3. A washout period of at least 21 days will be maintained between each treatment period. |
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| Optional Part 3: Treatment Sequence (FED) | Experimental | Participants will receive Treatment F on Day 1 of period 1 then Treatment E on Days 1 to 5 of period 2 followed by Treatment D on Days 1 of period 3. A washout period of at least 21 days will be maintained between each treatment period. |
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| Optional Part 3: Treatment Sequence (EDF) | Experimental | Participants will receive Treatment E on Days 1 to 5 of period 1 then Treatment D on Day 1 of period 2 followed by Treatment F on Day 1 of period 3. A washout period of at least 21 days will be maintained between each treatment period. |
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| Optional Part 3: Treatment Sequence (DFE) | Experimental | Participants will receive Treatment D on Day 1 period 1 then Treatment F on Day 1 of period 2 followed by Treatment E on Days 1 to 5 of period 3. A washout period of at least 21 days will be maintained between each treatment period. |
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| Lansoprazole | Drug | Participants will receive single oral dose of 30 mg lansoprazole capsule as per assigned treatment sequence. |
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| Ranitidine | Drug | Participants will receive single oral dose of 150 mg ranitidine as per assigned treatment sequence. |
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| Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-63549109 (Metabolite of JNJ-64041575) | 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 (0-last) and C (0-last)/ lambda(z); wherein AUC (0- last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant. | Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months) |
| Elimination Half-Life (T1/2) of JNJ-63549109 (Metabolite of JNJ-64041575) | T1/2 is the apparent terminal elimination half-life, calculated as 0.693/Lambda(z). | Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months) |
| Elimination Rate Constant (Lambda[z]) of JNJ-63549109 (Metabolite of JNJ-64041575) | Lambda[z] is the apparent terminal elimination rate constant, estimated by linear regression using the terminal logarithmic (log)-linear phase of the log-transformed concentration vs time data. | Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months) |
C24h is observed plasma concentration at 24 hours post dose. |
| 24 hours postdose (Day 2) |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-64167896 (Metabolite of JNJ-64041575) | Cmax is the maximum observed plasma concentration. | Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-64167896 (Metabolite of JNJ-64041575) | Tmax is the actual sampling time to reach maximum observed plasma concentration. | Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months) |
| Area Under Plasma Concentration Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of JNJ-64167896 (Metabolite of JNJ-64041575) | Area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit [non BQL]) concentration, calculated by linear trapezoidal summation. | Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months) |
| Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-64167896 (Metabolite of JNJ-64041575) | 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 (0-last) and C (0-last)/ lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant. | Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months) |
| Elimination Half-Life (T1/2) of JNJ-64167896 (Metabolite of JNJ-64041575) | T1/2 is the apparent terminal elimination half-life, calculated as 0.693/Lambda(z). | Predose, 15 min, 30 min,1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months) |
| Elimination Rate Constant (Lambda[z]) of JNJ 64167896 (Metabolite of JNJ-64041575) | Lambda[z] is the apparent terminal elimination rate constant, estimated by linear regression using the terminal logarithmic (log)-linear phase of the log-transformed concentration vs time data. | Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months) |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. | Up to end of study (approximately 6 months) |
| ID | Term |
|---|---|
| C000597470 | 4'-chloromethyl-2'-deoxy-3',5'-di-O-isobutyryl-2'-fluorocytidine |
| D064747 | Lansoprazole |
| D011899 | Ranitidine |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005663 | Furans |
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