Conditions: Renal Insufficiency
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4
Healthy volunteers: yes

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.

Detailed description:

Arms:
arm 1: Healthy volunteers with normal renal function arm 2: Patients with mild renal impairment arm 3: Patients with moderate renal impairment arm 4: Patients with severe renal impairment

Interventions: intervention 1: BI 207127 intervention 2: faldaprevir intervention 3: BI 207127 intervention 4: BI 207127 intervention 5: BI 207127 intervention 6: faldaprevir intervention 7: faldaprevir intervention 8: faldaprevir
Intervention descriptions: intervention 1: oral administration intervention 2: oral administration intervention 3: oral administration intervention 4: oral administration intervention 5: oral administration intervention 6: oral administration intervention 7: oral administration intervention 8: oral administration

Protocol document: