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

NCT01957657 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2016-04-11

Study results available
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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.

Conditions

  • Renal Insufficiency

Interventions

DRUG

BI 207127

oral administration

DRUG

faldaprevir

oral administration

DRUG

BI 207127

oral administration

DRUG

BI 207127

oral administration

DRUG

BI 207127

oral administration

DRUG

faldaprevir

oral administration

DRUG

faldaprevir

oral administration

DRUG

faldaprevir

oral administration

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01957657 on ClinicalTrials.gov