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

NCT01957657 | Terminated Phase 1 Results

• 2 other identifiers: 1241.322013-001075-21
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 4

Secondary Outcomes (9)

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

  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)

  Day 4

• AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)

  Day 4

• AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)

  Day 4

• AUC 0-infinity (Area Under the Concentration-time Curve of Faldaprevir in Plasma Over the Time Interval From 0 Extrapolated to Infinity)

  Day 4

Study Arms (4)

Healthy volunteers group 1

EXPERIMENTAL

Healthy volunteers with normal renal function

Drug: BI 207127; Drug: faldaprevir

Renal function group 2

EXPERIMENTAL

Patients with mild renal impairment

Drug: BI 207127; Drug: faldaprevir

Renal function group 3

EXPERIMENTAL

Patients with moderate renal impairment

Drug: BI 207127; Drug: faldaprevir

Renal function group 4

EXPERIMENTAL

Patients with severe renal impairment

Drug: BI 207127; Drug: faldaprevir

Interventions

BI 207127 DRUG

oral administration

Renal function group 2

faldaprevir DRUG

oral administration

Renal function group 2

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1241.32.1 Boehringer Ingelheim Investigational Site

Kiel, Germany

Location

Related Publications (1)

• Huang F, Moschetti V, Lang B, Halabi A, Petersen-Sylla M, Yong CL, Elgadi M. Pharmacokinetics, safety, and tolerability of faldaprevir in patients with renal impairment. Antimicrob Agents Chemother. 2015 Jan;59(1):251-7. doi: 10.1128/AAC.03359-14. Epub 2014 Oct 27.

  PMID: 25348520 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

deleobuvir; faldaprevir

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

The sponsor decided to stop the development of Hepatitis C treatments and terminated the trial prematurely on 27 Dec 2013. Due to the small sample size the pharmacokinetic endpoints were not determined.

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: October 1, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 11, 2016
• Results First Posted: April 11, 2016

Record last verified: 2016-03

Locations

DE (1)