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NCT Number: NCT01580306

Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment

The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after single dose of BI 201335.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1220.58.1 Boehringer Ingelheim Investigational Site

Kiel, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and female healthy subjects with normal renal function and subjects with impaired renal function in relatively good health

Exclusion criteria

Any relevant deviation from healthy conditions for healthy volunteers or significant diseases other than renal impairment for the renal impaired subjects

Treatment and study plan

BI 201335

Drug

Relevant treatment dose capsule (A) for oral administration

Primary outcomes

  1. AUC0-∞

    Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration

    area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity.

    In this endpoint, the data of AUC0-∞ show inter-individual variabilities.

  2. Cmax

    Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration

    maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.

Secondary outcomes

  1. Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG

    Time frame: from drug administration up to 2 weeks

    Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

  2. Number of Participants With Drug Related Adverse Events

    Time frame: drug administration until end-of-study examination (7 to 14 days after drug administration)

    number of participants with investigator-defined drug related adverse events.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Pharmacokinetics, Safety and Tolerability of BI 201335 in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Monocentric, Open-label, Parallel-group, Phase I Trial

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 19, 2012
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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