Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Single Center, Open-label, Parallel-group, Phase I Trial
Overview
- Phase
- Phase 1
- Intervention
- BI 207127
- Conditions
- Renal Insufficiency
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
The objective of the trial is to investigate the effect of different degrees of renal impairment on the pharmacokinetics and safety of the combination of BI 207127 and faldaprevir after 3 days of dosing (BI 207127 bid, faldaprevir qd) and a single dose of BI 207127 and faldaprevir on day 4.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Renal function group 4
Patients with severe renal impairment
Intervention: BI 207127
Renal function group 3
Patients with moderate renal impairment
Intervention: BI 207127
Renal function group 3
Patients with moderate renal impairment
Intervention: faldaprevir
Renal function group 2
Patients with mild renal impairment
Intervention: BI 207127
Renal function group 2
Patients with mild renal impairment
Intervention: faldaprevir
Healthy volunteers group 1
Healthy volunteers with normal renal function
Intervention: BI 207127
Healthy volunteers group 1
Healthy volunteers with normal renal function
Intervention: faldaprevir
Renal function group 4
Patients with severe renal impairment
Intervention: faldaprevir
Outcomes
Primary Outcomes
AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Time Frame: Day 4
Blood sampling for Pharmacokinetic (PK) profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.
Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) in Plasma)
Time Frame: Day 4
Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.
Secondary Outcomes
- Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma)(Day 4)
- Number (%) of Subjects With Drug-related Adverse Events(From the first drug administration until last drug administration, up to 10 days)
- AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)(Day 4)
- AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)(Day 4)
- AUC 0-infinity (Area Under the Concentration-time Curve of Faldaprevir in Plasma Over the Time Interval From 0 Extrapolated to Infinity)(Day 4)
- Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma)(Day 4)
- Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma)(Day 4)
- Cmax (Maximum Measured Concentration of Faldaprevir in Plasma)(Day 4)
- AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)(Day 4)