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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003697-10 | EudraCT Number | EudraCT |
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The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with faldaprevir in healthy male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental | For the first 9 days patients receive BI 207127 low dose or high dose, then BI 207127 high dose with faldaprevir |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 207127 + faldaprevir | Drug | fixed dose combination |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Healthy Subjects With AEs (Multiple Rising Dose Part) | Number of healthy subjects with any adverse event (AE) during the on-treatment period. | From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration) |
| AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part) | Area under the concentration-time curve (AUC) of Deleobuvir over the uniform dosing interval 0 to 12 h (hours) on Day 1 and at steady state on Day 16. | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 hours (h) after drug administration in the morning. |
| Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part) | Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 16. | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part) | Concentration of Deleobuvir at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part) | Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part) | Area under the concentration-time curve of Deleobuvir over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9. | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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Inclusion criteria:
1. healthy male and female subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1241.35.1 Boehringer Ingelheim Investigational Site | Mannheim | Germany |
The 600mg dose cohort was to be started at least 6 days after the 400mg dose cohort was completed and the combined treatment cohort (600mg Deleobuvir + 120mg Faldaprevir) was started after the evaluation of key safety and tolerability data of the individual treatments.
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| ID | Title | Description |
|---|---|---|
| FG000 | 400 mg Deleobuvir | 400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part. |
| FG001 | 600 mg Deleobuvir |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| Cmax and Cmax,ss of CD 6168 (Combined Treatment Part) | Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir. | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part) | Concentration of CD 6168 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir. | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part) | Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir. | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| Cmax and Cmax,ss of BI 208333 (Combined Treatment Part) | Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir. | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part) | Concentration of BI 208333 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir. | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part) | Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir. | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part) | Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir. | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part) | Concentration of CD 6168 acylglucuronide at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir. | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part) | Area under the concentration-time curve of Faldaprevir over the uniform dosing interval 0 to 24 h on Day 1 and at steady state on Day 16. | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part) | Maximum measured concentration of Faldaprevir on Day 1 and at steady state on Day 16. | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12, 24 h after drug administration in the morning. |
| Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part) | Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 9. | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part) | Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9. CD 6168 is a major metabolite of Deleobuvir. | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part) | Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 9. CD 6168 is a major metabolite of Deleobuvir. | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part) | Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9. BI 208333 is a major metabolite of Deleobuvir. | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part) | Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 9. BI 208333 is a major metabolite of Deleobuvir. | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part) | Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9. CD 6168 acylglucuronide is a metabolite of Deleobuvir. | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
| Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part) | Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 9. CD 6168 acylglucuronide is a metabolite of Deleobuvir. | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
| FG002 | 600 mg Deleobuvir + 120 mg Faldaprevir | 600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days. Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part. |
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| NOT COMPLETED |
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The study comprised 2 trial parts: a multiple rising dose part (Part 1) followed by a combined treatment part (Part 2). The multiple rising dose part was performed in an open-label, non-randomised, non-placebocontrolled manner with 2 dose groups. The combined treatment part was conducted open-label in 1 treatment group.
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| ID | Title | Description |
|---|---|---|
| BG000 | 400 mg Deleobuvir | 400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part. |
| BG001 | 600 mg Deleobuvir | 600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part. |
| BG002 | 600 mg Deleobuvir + 120 mg Faldaprevir | 600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days. Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||
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| Secondary | AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part) | Area under the concentration-time curve of Deleobuvir over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Primary | Number of Healthy Subjects With AEs (Multiple Rising Dose Part) | Number of healthy subjects with any adverse event (AE) during the on-treatment period. | Treated Set. The treated set included all subjects who were documented to have taken at least 1 dose of study medication. | Posted | Number | participants | From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration) |
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| Primary | AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part) | Area under the concentration-time curve (AUC) of Deleobuvir over the uniform dosing interval 0 to 12 h (hours) on Day 1 and at steady state on Day 16. | PKS. The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least 1 observation for at least 1 pharmacokinetic endpoint without important protocol violations relevant for the statistical evaluation of pharmacokinetic endpoints. Including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 hours (h) after drug administration in the morning. |
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| Primary | Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part) | Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 16. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Primary | C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part) | Concentration of Deleobuvir at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Primary | AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part) | Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Secondary | Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part) | Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 9. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Secondary | AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part) | Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9. CD 6168 is a major metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Secondary | Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part) | Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 9. CD 6168 is a major metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Secondary | AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part) | Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9. BI 208333 is a major metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Secondary | Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part) | Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 9. BI 208333 is a major metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Secondary | AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part) | Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9. CD 6168 acylglucuronide is a metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Secondary | Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part) | Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 9. CD 6168 acylglucuronide is a metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Primary | Cmax and Cmax,ss of CD 6168 (Combined Treatment Part) | Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Primary | C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part) | Concentration of CD 6168 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Primary | AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part) | Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Primary | Cmax and Cmax,ss of BI 208333 (Combined Treatment Part) | Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Primary | C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part) | Concentration of BI 208333 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Primary | AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part) | Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Primary | Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part) | Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Primary | C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part) | Concentration of CD 6168 acylglucuronide at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Primary | AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part) | Area under the concentration-time curve of Faldaprevir over the uniform dosing interval 0 to 24 h on Day 1 and at steady state on Day 16. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning. |
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| Primary | Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part) | Maximum measured concentration of Faldaprevir on Day 1 and at steady state on Day 16. | PKS including patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12, 24 h after drug administration in the morning. |
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From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
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 | 400 mg Deleobuvir | 400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part. | 0 | 8 | 6 | 8 | ||
| EG001 | 600 mg Deleobuvir | 600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part. | 0 | 8 | 5 | 8 | ||
| EG002 | 600 mg Deleobuvir + 120 mg Faldaprevir | 600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days. Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part. | 0 | 16 | 9 | 16 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Folliculitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Cheilitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Polymenorrhoea | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA 15.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| C000592437 | deleobuvir |
| C552340 | faldaprevir |
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