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| ID | Type | Description | Link |
|---|---|---|---|
| TMC278IFD1008 | Other Identifier | Janssen Sciences Ireland UC | |
| 2015-002511-14 | EudraCT Number |
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The purpose of this study is to compare the rate and extent of absorption of rilpivirine in healthy adult participants following: 1) administration of a single dose of two different oral dispersible tablet formulation candidates and of an oral granules formulation with that following administration of a single dose of the 25-milligram (mg) oral tablet (EDURANT), after a standardized breakfast; 2) administration of a single dose of one selected oral formulation candidate (a dispersible tablet or granules) in different fed conditions (standardized breakfast or yoghurt) and in the fasted state and breakfast and 3) administration of a single dose of one selected oral formulation candidate (a dispersible tablet or granules) dispersed in water or in orange juice, in fed condition (standardized breakfast).
This is a Phase 1, open-label, randomized, 2-panel, 4-way crossover study in healthy adult participants to assess the relative bioavailability of rilpivirine following single dose administration of oral pediatric formulation candidates (two dispersible tablet formulations and one granules formulation), compared to the commercially available 25-mg tablet (EDURANT) and to assess the effect of food and different food constituents on the oral bioavailability of rilpivirine following single dose administration of one selected formulation candidate. The study will consist of 2 panels: Panel 1 and Panel 2. In each panel, participants will be randomized to receive treatment A, B, C, D and E, F, G, H, respectively. Pharmacokinetic parameters will be evaluated primarily. Safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel 1: Group 1 | Experimental | Participants will receive Treatment A (25 milligram [mg] rilpivirine [RPV] formulated as the oral tablet under fed condition [standardized breakfast]) followed by Treatment D (25 mg RPV formulated as granules formulation G002 [10 g of 2.5 mg/g granules, dispersed in water] under fed [standardized breakfast]) followed by Treatment B (25 mg RPV formulated as dispersible tablet formulation G007 [10*2.5 mg tablets, dispersed in water] under fed condition) followed by Treatment C (25 mg RPV formulated as dispersible tablet formulation G009-01 [10*2.5 mg tablets, dispersed in water] under fed condition). |
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| Panel 1: Group 2 | Experimental | Participants will receive treatment B followed by treatment A then treatment C followed by treatment D. |
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| Panel 1: Group 3 | Experimental | Participants will receive treatment C followed by treatment B then treatment D followed by treatment A. |
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| Panel 1: Group 4 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rilpivirine Oral Tablet | Drug | Rilpivirine formulated as 25 mg oral tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | The Cmax is the maximum observed plasma concentration. | Up to Hour 168 |
| 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. | Up to Hour 168 |
| 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. | Up to Hour 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | The Tmax is defined as time to reach maximum observed analyte concentration. | Up to Hour 168 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Sciences Ireland UC Clinical Trial | Janssen Sciences Ireland UC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp | Belgium |
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| Experimental |
Participants will receive treatment D followed by treatment C then treatment A followed by treatment B. |
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| Panel 2: Group 1 | Experimental | Participants will receive Treatment E (25 mg RPV formulated as dispersible tablet formulation G007 or G009-01 or as granules formulation G002 [10*2.5 mg tablets or 10 g of 2.5 mg/g granules, dispersed in water] under fed [standardized breakfast] condition) followed by Treatment H (25 mg RPV formulated as dispersible tablet formulation G007 or G009-01 or as granules formulation G002 [10*2.5 mg tablets or 10 g of 2.5 mg/g granules, dispersed in water] under fed [yoghurt] condition) followed by Treatment F (25 mg RPV formulated as dispersible tablet formulation G007 or G009-01 or as granules formulation G002 [10*2.5 mg tablets or 10 g of 2.5 mg/g granules, dispersed in water] under fasted condition) followed by Treatment G (25 mg RPV formulated as dispersible tablet formulation G007 or G009-01 or as granules formulation G002 [10*2.5 mg tablets or 10 g of 2.5 mg/g granules, dispersed in water] under fed [standardized breakfast] condition). |
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| Panel 2: Group 2 | Experimental | Participants will receive Treatment F followed by Treatment E then Treatment G followed by Treatment H. |
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| Panel 2: Group 3 | Experimental | Participants will receive Treatment G followed by Treatment F then Treatment H followed by Treatment E. |
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| Panel 2: Group 4 | Experimental | Participants will receive Treatment H followed by Treatment G then Treatment E followed by Treatment F. |
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| Rilpivirine formulation G007 | Drug | Rilpivirine G007 formulation as 10*2.5 mg tablets. |
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| Rilpivirine formulation G009-01 | Drug | Rilpivirine G009-01 formulation as 10*2.5 mg tablets. |
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| Rilpivirine formulation G002 | Drug | Rilpivirine G002 formulation as 10 g of 2.5 milligram per gram (mg/gm) granules. |
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| Standardized Breakfast | Dietary Supplement | It will consist of (or its equivalent) 4 slices of bread, 2 slices of ham and/or cheese, butter, fruit preserve and 1 or 2 cups (up to 480 milliliter [mL]) of decaffeinated coffee or decaffeinated tea with milk and/or sugar, if desired (containing approximately fat: 21 gram (gm), carbohydrates: 67 gm, proteins: 19 gm; calories 533 kilocalorie (kcal) [189 kcal from fat, 268 kcal from carbohydrates, and 76 kcal from proteins]). |
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| Up to Hour 168 |
| 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). | Up to Hour 168 |
| 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. | From signing of the informed consent form up to 30 days after last dose of study drug (Day 1) |
| Number of Participants with Taste Questionnaire Score | The first part of the taste questionnaire rates sweetness, bitterness and flavour as well as overall acceptability in a 4-point scale (grading from worse to best). In the second part of the taste questionnaire the overall taste is assessed using a 5-point visual hedonic scale (categorical 5 point assessment). | 15 minutes after study drug intake in each treatment period in both panels |
| ID | Term |
|---|---|
| D000068696 | Rilpivirine |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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