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| ID | Type | Description | Link |
|---|---|---|---|
| TMC435HPC1010 | Other Identifier | Janssen Sciences Ireland UC | |
| 2014-005448-17 | EudraCT Number |
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The purpose of this study is to assess the relative bioavailability (the extent to which a drug or other substance becomes available to the body) of simeprevir (SMV) following single dose administration of age-appropriate oral formulation candidates compared to the 150 milligram (mg) capsule, and to assess the effect of food on the bioavailability of SMV following single dose administration of a selected age-appropriate oral formulation candidate.
This is a Phase 1, open-label (all people know the identity of the intervention), randomized (study medication assigned to participants by chance), 2-panel, 3-way crossover (participants will receive different interventions sequentially during the trial) study in healthy adult participants. Participants will be equally divided over 2 panels, and will not be randomized between panels. Participants will not be allowed to switch panels. The study consists of 3 parts: Screening Phase (that is, 28 days before study commences on Day 1); Open-label Treatment (in subsequent 3-treatment periods in each Panel, each separated with washout period of 7 days); and Post-Treatment Phase (up to 7 days after last study drug intake). The duration of the study per participant will be at least 19 days, screening and follow-up not included. All the eligible participants will be randomly assigned to 1 of the 6 treatment sequences in each Panel. In fasted conditions, study drug will be administered following a 10-hour overnight fast. In fed conditions, participants will also fast from food for 10 hours, but will consume a high fat/high calorie breakfast within a 30-minute period. Study drug will be administered 30 minutes after the start of breakfast. Participants will not be allowed to have food until at least 4 hours after study drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of SMV formulations will be evaluated primarily. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel1: Sequence 1 (ABC) | Experimental | Participants will receive Treatment A (150 milligram (mg) simeprevir (SMV) capsule with water under fed conditions) in Period 1; followed by Treatment B (3*50 mg capsules of SMV [including 50 mini-tablets of 1 mg each] with water under fed conditions) in Period 2; followed by Treatment C (3*50 mg dispersible SMV tablets dispersed in water under fed conditions) in Period 3. A washout period of at least 7 days will be maintained between each treatment period. |
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| Panel1: Sequence 2 (BCA) | Experimental | Participants will receive Treatment B in Period 1; followed by Treatment C in Period 2; followed by Treatment A in Period 3. A washout period of at least 7 days will be maintained between each treatment period. |
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| Panel1: Sequence 3 (CAB) | Experimental | Participants will receive Treatment C in Period 1; followed by Treatment A in Period 2; followed by Treatment B in Period 3. A washout period of at least 7 days will be maintained between each treatment period. |
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| Panel1: Sequence 4 (CBA) | Experimental | Participants will receive Treatment C in Period 1; followed by Treatment B in Period 2; followed by Treatment A in Period 3. A washout period of at least 7 days will be maintained between each treatment period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A | Drug | 150 milligram (mg) SMV capsule with water under fed conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Simeprevir (SMV) | The Cmax is the maximum observed plasma concentration of SMV. | Baseline up to 72 hours post-administration of study drug |
| Time to Reach the Maximum Plasma Concentration (Tmax) of SMV | The Tmax is the time to reach the maximum observed plasma concentration of SMV. | Baseline up to 72 hours post-administration of study drug |
| Area Under the Plasma Concentration-Time Curve From 0 to last (AUC[0-last]) Post Dose of SMV | AUC (0-last) from time 0 to the time of the last measurable (non-below quantification limit [BQL]) concentration, calculated by linear-linear trapezoidal summation. | Baseline up to 72 hours post-administration of study drug |
| Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of SMV | The AUC (0-infinity) is the area under the plasma concentration-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 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. | Baseline up to 72 hours post-administration of study drug |
| Elimination Rate Constant (Lambda [z]) of SMV | The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve. | Baseline up to 72 hours post-administration of study drug |
| Terminal Half-life (t[1/2]) of SMV |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants within Each Category of Taste Questionnaire | Participants will assess the palatability of the SMV formulations by Taste Questionnaire, Question 1 will assess sweetness, bitterness, flavor and overall taste of the formulation; and Question 2 consists of visual analog scale wherein participants will put a cross in the box beneath the scores, corresponding to the 5-point hedonic scale (dislike it very much; dislike it a little; not sure, like it a little, like it very much). |
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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 |
|---|---|---|---|---|---|---|
| Harrow | United Kingdom |
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| Panel1: Sequence 5 (BAC) | Experimental | Participants will receive Treatment B in Period 1; followed by Treatment A in Period 2; followed by Treatment C in Period 3. A washout period of at least 7 days will be maintained between each treatment period. |
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| Panel1: Sequence 6 (ACB) | Experimental | Participants will receive Treatment A in Period 1; followed by Treatment C in Period 2; followed by Treatment B in Period 3. A washout period of at least 7 days will be maintained between each treatment period. |
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| Panel 2: Sequence 1 (DEF) | Experimental | Participants will receive Treatment D (3*50 mg SMV capsules [including 50 mini-tablets of 1 mg each] with water or 3*50 mg dispersible SMV tablets dispersed in water under fed conditions) in Period 1; followed by Treatment E (3*50 mg SMV capsules [including 50 mini-tablets of 1 mg each] with water or 3*50 mg dispersible SMV tablets dispersed in water under fasted conditions) in Period 2; followed by Treatment F (3*50 mg SMV capsules [including 50 mini-tablets of 1 mg each] with yoghurt or 3*50 mg dispersible SMV tablets dispersed in apple juice under fed conditions) in Period 3. A washout period of at least 7 days will be maintained between each treatment period. |
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| Panel 2: Sequence 2 (EFD) | Experimental | Participants will receive Treatment E in Period 1; followed by Treatment F in Period 2; followed by Treatment D in Period 3. A washout period of at least 7 days will be maintained between each treatment period. |
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| Panel 2: Sequence 3 (FDE) | Experimental | Participants will receive Treatment F in Period 1; followed by Treatment D in Period 2; followed by Treatment E in Period 3. A washout period of at least 7 days will be maintained between each treatment period. |
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| Panel 2: Sequence 4 (FED) | Experimental | Participants will receive Treatment F in Period 1; followed by Treatment E in Period 2; followed by Treatment D in Period 3. A washout period of at least 7 days will be maintained between each treatment period. |
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| Panel 2: Sequence 5 (EDF) | Experimental | Participants will receive Treatment E in Period 1; followed by Treatment D in Period 2; followed by Treatment F in Period 3. A washout period of at least 7 days will be maintained between each treatment period. |
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| Panel 2: Sequence 6 (DFE) | Experimental | Participants will receive Treatment D in Period 1; followed by Treatment F in Period 2; followed by Treatment E in Period 3. A washout period of at least 7 days will be maintained between each treatment period. |
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| Treatment B | Drug | Treatment B (3*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions. |
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| Treatment C | Drug | Treatment C (3*50 mg dispersible SMV tablets dispersed in water under fed conditions). |
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| Treatment D | Drug | *50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3*50 mg dispersible SMV tablets dispersed in water under fed conditions. |
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| Treatment E | Drug | 3*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3*50 mg dispersible SMV tablets dispersed in water under fasted conditions. |
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| Treatment F | Drug | 3*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with yoghurt or 3*50 mg dispersible SMV tablets dispersed in apple juice under fed conditions. |
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The t(1/2) is defined as 0.693/Lambda (z). |
| Baseline up to 72 hours post-administration of study drug |
| 5 to 15 minutes post administration of study drug (up to Day 19) |
| 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. | Screening up to follow-up (7 days after last dose administration) |
| ID | Term |
|---|---|
| D000069616 | Simeprevir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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