Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients

Phase 1TerminatedNCT01957657

Boehringer Ingelheim4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Insufficiency

Interventions

BI 207127DRUG

oral administration

faldaprevirDRUG

oral administration

BI 207127DRUG

oral administration

BI 207127

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Healthy volunteers (males and females) or patients with impaired renal function (estimated glomerular filtration rate (eGFR) between 89 and 15) in relatively good health as determined by past medical history, physical examination, vital signs, ECG and laboratory assessments (aside from abnormalities specific for renal impairment) * Age from 18 to 79 years * Subjects must be able to understand and comply with study requirements Exclusion criteria: * Any relevant deviation from healthy conditions for healthy volunteers * Subjects with significant diseases other than renal impairment will be excluded. A significant disease is defined as a disease which in the opinion of the investigator: * put the patient at risk because of participation in the study * may influence the results of the study * may influence the patients ability to participate in the study * is not in a stable condition * Diabetic or hypertensive patients can be entered in this trial if the disease is not significant according to these criteria

Locations (1)

1241.32.1 Boehringer Ingelheim Investigational Site

Kiel, Germany

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)

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.

Time frame: Day 4

Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) in Plasma)

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.

Time frame: Day 4

Secondary Outcomes

Number (%) of Subjects With Drug-related Adverse Events

Number (percentage) of subjects with drug-related adverse events

Time frame: 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)

Time frame: Day 4

Data from ClinicalTrials.gov

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