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| ID | Type | Description | Link |
|---|---|---|---|
| 54861911ALZ1003 | Other Identifier | Janssen Research & Development, LLC | |
| 2013-002650-70 | EudraCT Number |
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The purpose of this study is to determine pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and the relative-bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-54861911 solid dosage formulation compared with JNJ 54861911 oral suspension formulation in healthy older male participants.
This is a randomized (study medication assigned to participants by chance), open-label (all people know the identity of the intervention), single-center, single-dose and 3-way Crossover (the same medications provided to all participants but in different sequence) study to determine the bioavailability of JNJ-54861911 solid dosage formulation in healthy older male participants. The study will consist of 3 parts: Screening Phase (that is, 28 days before study commences on Day 1), an open-label treatment Phase (consists of 3 single-dose treatment periods, either a single oral suspension formulation [Treatment A] or solid formulation 25 milligram (mg) dose of JNJ-54861911 under fasted [Treatment B] or fed conditions [Treatment C] in subsequent 3-treatment periods; each treatment period separated with washout period of 6 days) and follow-up Phase (7 to 14 days after last dose administration). The maximal study duration for a participant will not exceed 8 weeks. All the eligible participants will be randomly assigned to 1 of the 6 treatment sequences. Followed by an overnight fast of at least 10 hours participants will be administered with study treatment under fasted condition or fed condition (30 minutes after high-fat, high-calorie breakfast). Participants will not be allowed to have food until 4 hours of drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Bioavailability will be primarily evaluated by pharmacokinetic parameters. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (ABC) | Experimental | Participants will receive Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 1; followed by Treatment B (single oral dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 2; followed by Treatment C (single oral dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period. |
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| Sequence 2 (ACB) | Experimental | Participants will receive Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 1; followed by Treatment C (single oral dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 2; followed by Treatment B (single oral dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period. |
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| Sequence 3 (BAC) | Experimental | Participants will receive Treatment B (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 1; followed by Treatment A (single oral dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 2; followed by Treatment C (single oral dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-54861911 (Treatment A) | Drug | Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment A (oral suspension formulation) under fasted conditions in one of the treatment periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of JNJ-54861911 | The Cmax is the maximum observed plasma concentration of JNJ-54861911. | Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period |
| Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-54861911 | The Tmax is the time to reach the maximum observed plasma concentration of JNJ-54861911. | Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period |
| Area Under the Plasma Concentration-Time Curve From 0 to t Hours (AUC[0-t]) Post Dose of JNJ-54861911 | The AUC (0-t) calculated by trapezoidal summation [time t is the time of the last quantifiable concentration (C[last])]. | Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period |
| Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-54861911 | The AUC (0-infinity) is the area under the plasma JNJ-54861911concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-54861911 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant. | Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period |
| Elimination Rate Constant (Lambda [z]) of JNJ-54861911 | The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious AEs | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
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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 |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
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| Sequence 4 (BCA) | Experimental | Participants will receive Treatment B (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 1; followed byTreatment C (single dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 2; followed by Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period. |
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| Sequence 5 (CAB) | Experimental | Participants will receive Treatment C (single dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 1; followed by Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 2; followed by Treatment B (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period. |
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| Sequence 6 (CBA) | Experimental | Participants will receive Treatment C (single dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 1; followed by Treatment B (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 2; followed by Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period. |
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| JNJ-54861911 (Treatment B) | Drug | Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment B (solid formulation) under fasted conditions in one of the treatment periods. |
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| JNJ-54861911 (Treatment C) | Drug | Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment C (solid formulation) under fed conditions in one of the treatment periods. |
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| Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period |
| Terminal Half-life (t[1/2]) of JNJ-54861911 | The t(1/2) is defined as 0.693/Lambda (z). | Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period |
| Relative Bioavailability (F[rel]) of JNJ-54861911 | Relative bioavailability, calculated as individual Cmax and AUC treatment ratios (for the comparison of food effect). | Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period |
| Rate of Absorption of JNJ-54861911 | Rate of absorption will be measured using the peak concentration of JNJ-54861911 (following administration of solid dosage form and suspension dosage form) under fasted conditions and fed conditions. | Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period |
| Extent of Absorption of JNJ-54861911 | Extent of absorption will be measured under fasted conditions and fed conditions, using the area under plasma concentrations of JNJ-54861911 versus time from time 0 to the last sample point (AUC[0-t]) and from time 0 to infinity (AUC[0-inf]). | Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period |
| Screening up to follow-up (7 to 14 days after last dose administration) |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000634126 | atabecestat |
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