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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003435-30 | EudraCT Number | EudraCT |
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The primary objective of this trial is to investigate the effect of multiple-dose faldaprevir (FDV) on the single-dose pharmacokinetics of cyclosporine or tacrolimus
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Cyclosporine + Faldaprevir | Experimental |
| |
| 2 Tacrolimus + Faldaprevir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faldaprevir | Drug |
| ||
| Faldaprevir |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-infinity (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | AUC 0-infinity (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 extrapolated to infinity). PK sampling (relative to the first cyclo administration [h:min]) Period 1: for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h. period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h. | up to 168 hours (details in description) |
| AUC 0-tz (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 to the Last Quantifiable Point) | AUC 0-tz (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 to the last quantifiable point). PK sampling (relative to the first cyclo administration [h:min]): Period 1: for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h. | up to 168 hours (details in description) |
| Cmax (Maximum Measured Concentration of the Cyclo in Plasma) | Cmax (maximum measured concentration of the cyclo in plasma). PK sampling (relative to the first cyclo administration [h:min]): Period 1: for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h | up to 168 hours (details in description) |
| Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Cyclo Treatment] in Plasma at Steady State Over a Uniform Dosing Interval Ï„) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1241.61.1 Boehringer Ingelheim Investigational Site | Mannheim | Germany |
Not provided
The trial was nonrandomised, open-label and fixed-sequence and was performed in 2 separate groups of 2 periods each in healthy male and female volunteers. Treatments for the two periods were in group 1 cyclosporine (cyclo) and cyclo and faldaprevir (FDV), and in Group 2 tacrolimus (tac) and tac and FDV.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cyclosporine / Cyclosporine + Faldaprevir | fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods. |
| FG001 | Tacrolimus / Tacrolimus + Faldaprevir | fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cyclo or Tac (Single Dose, Day 1) |
|
| ||||||||||||||||||
| Cyclo or Tac (Day 1) + FDV (Day -7 to 7) |
|
treated set (TS): included all subjects who took at least one dose of study medication during the treatment period.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cyclosporine / Cyclosporine + Faldaprevir | fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC 0-infinity (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | AUC 0-infinity (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 extrapolated to infinity). PK sampling (relative to the first cyclo administration [h:min]) Period 1: for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h. period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h. | pharmacokinetic set of cyclo (PKS cyclo): The subject set for the evaluation of PK endpoints was to include all treated subjects who provided at least 1 observation of cyclo in plasma for at least 1 primary endpoint, and who did not have important protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | up to 168 hours (details in description) |
|
from the date of start trial medication to 28 days after the last trial medication.
Group 1: 16 subjects (sub) treated with cyclosporine (cyclo). After a washout phase the second period started. 15 sub. treated with Faldaprevir (FDV) (Day -7 to 7); 14 subjects treated with a cyclo on Day 1. Group 2: 15 of 16 sub. treated with tacrolimus (tac). After the washout in the second period 15 sub. were treated with FDV alone and FDV+tac.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cyclosporine (Cyclo) | Cyclosporine (cyclo) 50 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ligament sprain | Injury, poisoning and procedural complications | MEDDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 17.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| C552340 | faldaprevir |
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
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|
| Cyclosporine | Drug |
|
| Tacrolimus | Drug |
|
Cmax,ss (maximum measured concentration of the FDV [followed by cyclo treatment] in plasma at steady state over a uniform dosing interval Ï„).
PK sampling (relative to the first cyclo administration [h:min]):
period 2 For FDV
-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h
| up to 168 hours (details in description) |
| C24,ss (Maximum Measured Concentration of the FDV in Plasma at Steady State Over a 24 Hour Dosing Interval) | PK sampling (relative to the first cyclo administration [h:min]): period 2 For FDV -144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h | up to 168 hours (details in description) |
| AUC Ï„,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval Ï„) | AUC Ï„,ss (area under the concentration-time curve of the FDV in plasma at steady state over a uniform dosing interval Ï„). PK sampling (relative to the first cyclo administration [h:min]): period 2 For FDV -144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h | up to 168 hours (details in description) |
| AUC 0-infinity (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | AUC 0-infinity (area under the concentration-time curve of the tac in plasma over the time interval from 0 extrapolated to infinity). PK sampling (relative to the first tac administration): Period 1: for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h period 2 for tac -192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h | up to 192 hours (details in description) |
| AUC 0-tz (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 to the Last Quantifiable Point) | AUC 0-tz (area under the concentration-time curve of the tac in plasma over the time interval from 0 to the last quantifiable point). PK sampling (relative to the first tac administration [h:min]): Period 1: for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h Period 2 For tac -192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h | up to 192 hours (details in description) |
| Cmax (Maximum Measured Concentration of the Tac in Plasma) | Cmax (maximum measured concentration of the tac in plasma). PK sampling (relative to the first tac administration [h:min]): Period 1: for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h Period 2 For tac -192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h | up to 192 hours (details in description) |
| Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval Ï„) | Cmax,ss (maximum measured concentration of the FDV [followed by tac treatment] in plasma at steady state over a uniform dosing interval Ï„). PK sampling (relative to the first tac administration [h:min]): period 2 For FDV -144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h. | up to 168 hours (details in description) |
| C24,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a 24 Hour Dosing Interval) | PK sampling (relative to the first tac administration [h:min]): period 2 For FDV -144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h. | up to 168 hours (details in description) |
| AUC Ï„,ss (Area Under the Concentration-time Curve of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval Ï„) | AUC Ï„,ss (area under the concentration-time curve of the FDV [followed by tac treatment] in plasma at steady state over a uniform dosing interval Ï„). PK sampling (relative to the first cyclo administration [h:min]): period 2 For FDV -144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h. | up to 168 hours (details in description) |
| NOT COMPLETED |
|
|
| BG001 | Tacrolimus / Tacrolimus + Faldaprevir | fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | Cyclosporine | fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1. |
| OG001 | Cyclosporine + Faldaprevir | fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2. |
|
|
|
| Primary | AUC 0-tz (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 to the Last Quantifiable Point) | AUC 0-tz (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 to the last quantifiable point). PK sampling (relative to the first cyclo administration [h:min]): Period 1: for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h. | PKS cyclo | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | up to 168 hours (details in description) |
|
|
|
|
| Primary | Cmax (Maximum Measured Concentration of the Cyclo in Plasma) | Cmax (maximum measured concentration of the cyclo in plasma). PK sampling (relative to the first cyclo administration [h:min]): Period 1: for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h | PKS cyclo | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | up to 168 hours (details in description) |
|
|
|
|
| Primary | Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Cyclo Treatment] in Plasma at Steady State Over a Uniform Dosing Interval Ï„) | Cmax,ss (maximum measured concentration of the FDV [followed by cyclo treatment] in plasma at steady state over a uniform dosing interval Ï„). PK sampling (relative to the first cyclo administration [h:min]): period 2 For FDV -144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h | PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | up to 168 hours (details in description) |
|
|
|
|
| Primary | C24,ss (Maximum Measured Concentration of the FDV in Plasma at Steady State Over a 24 Hour Dosing Interval) | PK sampling (relative to the first cyclo administration [h:min]): period 2 For FDV -144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h | PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | up to 168 hours (details in description) |
|
|
|
|
| Primary | AUC Ï„,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval Ï„) | AUC Ï„,ss (area under the concentration-time curve of the FDV in plasma at steady state over a uniform dosing interval Ï„). PK sampling (relative to the first cyclo administration [h:min]): period 2 For FDV -144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h | PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | up to 168 hours (details in description) |
|
|
|
|
| Primary | AUC 0-infinity (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | AUC 0-infinity (area under the concentration-time curve of the tac in plasma over the time interval from 0 extrapolated to infinity). PK sampling (relative to the first tac administration): Period 1: for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h period 2 for tac -192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h | pharmacokinetic set of tac (PKS tac): The subject set for the evaluation of PK endpoints was to include all treated subjects who provided at least 1 observation of tac in plasma for at least 1 primary endpoint, and who did not have important protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | up to 192 hours (details in description) |
|
|
|
|
| Primary | AUC 0-tz (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 to the Last Quantifiable Point) | AUC 0-tz (area under the concentration-time curve of the tac in plasma over the time interval from 0 to the last quantifiable point). PK sampling (relative to the first tac administration [h:min]): Period 1: for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h Period 2 For tac -192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h | PKS tac | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | up to 192 hours (details in description) |
|
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| Primary | Cmax (Maximum Measured Concentration of the Tac in Plasma) | Cmax (maximum measured concentration of the tac in plasma). PK sampling (relative to the first tac administration [h:min]): Period 1: for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h Period 2 For tac -192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h | PKS tac | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | up to 192 hours (details in description) |
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| Primary | Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval Ï„) | Cmax,ss (maximum measured concentration of the FDV [followed by tac treatment] in plasma at steady state over a uniform dosing interval Ï„). PK sampling (relative to the first tac administration [h:min]): period 2 For FDV -144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h. | PKS tac | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | up to 168 hours (details in description) |
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| Primary | C24,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a 24 Hour Dosing Interval) | PK sampling (relative to the first tac administration [h:min]): period 2 For FDV -144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h. | PKS tac | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | up to 168 hours (details in description) |
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| Primary | AUC Ï„,ss (Area Under the Concentration-time Curve of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval Ï„) | AUC Ï„,ss (area under the concentration-time curve of the FDV [followed by tac treatment] in plasma at steady state over a uniform dosing interval Ï„). PK sampling (relative to the first cyclo administration [h:min]): period 2 For FDV -144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h. | PKS tac | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | up to 168 hours (details in description) |
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|
| 0 |
| 16 |
| 6 |
| 16 |
| EG001 | Tacrolimus (Tac) | Tacrolimus (tac) 0.5 mg | 0 | 15 | 5 | 15 |
| EG002 | FDV (ff Cyclo) | FDV 120 mg (followed by cyclosporine) | 0 | 15 | 10 | 15 |
| EG003 | FDV (ff Tac) | FDV 120 mg (followed by tacrolimus) | 0 | 15 | 7 | 15 |
| EG004 | Cyclo+FDV | Cyclosporine 50 mg + FDV 120 mg | 0 | 14 | 4 | 14 |
| EG005 | Tac+FDV | Tacrolimus 0.5 mg + FDV 120 mg | 1 | 15 | 5 | 15 |
| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA 17.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MEDDRA 17.0 | Systematic Assessment |
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| Ocular icterus | Eye disorders | MEDDRA 17.0 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MEDDRA 17.0 | Systematic Assessment |
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| Photophobia | Eye disorders | MEDDRA 17.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Fatigue | General disorders | MEDDRA 17.0 | Systematic Assessment |
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| Feeling hot | General disorders | MEDDRA 17.0 | Systematic Assessment |
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| Pyrexia | General disorders | MEDDRA 17.0 | Systematic Assessment |
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| Rash pustular | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
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| Incorrect dose administered | Injury, poisoning and procedural complications | MEDDRA 17.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 17.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | Systematic Assessment |
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| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | Systematic Assessment |
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| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
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| Burning sensation | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MEDDRA 17.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MEDDRA 17.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MEDDRA 17.0 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MEDDRA 17.0 | Systematic Assessment |
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Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
H0: ratio is outside of interval (80%, 125%) vs. H1: ratio is inside of interval (80%, 125%) |
H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%) |
H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%) |
H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%) |
H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%) |
H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%) |
H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%) |
H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%) |
H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%) |
H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%) |
H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%) |