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

NCT01580306 | Completed Phase 1 Results

• 2 other identifiers: 1220.582011-005442-35
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

• AUC0-∞

  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.

  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

• Cmax

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

  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

Secondary Outcomes (2)

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

  from drug administration up to 2 weeks

• Number of Participants With Drug Related Adverse Events

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

Study Arms (2)

BI 201335 relevant treatment dose (A)

EXPERIMENTAL

Capsule for oral administration

Drug: BI 201335

BI 201335 relevant treatment dose (B)

EXPERIMENTAL

Capsule for oral administration

Drug: BI 201335

Interventions

BI 201335 DRUG

Relevant treatment dose capsule (A) for oral administration

BI 201335 relevant treatment dose (A)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1220.58.1 Boehringer Ingelheim Investigational Site

Kiel, Germany

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

faldaprevir

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 19, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 31, 2015
• Results First Posted: July 31, 2015

Record last verified: 2015-07

Locations

DE (1)