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

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Multiple Dose Study to Assess Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID Administered Orally for 9 Days (Part 1) and Multiple Doses of BI 207127 Combined With Faldaprevir Administered Orally for 16 Days (Part 2) in Healthy Male and Female Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 207127 + faldaprevir


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. healthy male and female subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients<br>For the first 9 days patients receive BI 207127 low dose or high dose, then BI 207127 high dose with faldaprevir | Drug: BI 207127 + faldaprevir<br>* fixed dose combination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. |