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Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
midazolam
BI 201335
tenofovir
caffeine
tolbutamide
tolbutamide
midazolam
caffeine
pegylated interferon
BI 201335
BI 201335
BI 207127
BI 207127
BI 201335
BI 207127
ribavirin
ribavirin
ribavirin
pegylated interferon
ribavirin
caffeine
tolbutamide
BI 207127
midazolam
BI 201335
BI 207127
ribavirin
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening
  2. Treatment naive or confirmed prior treatment relapse or partial response following treatment with interferon and ribavirin
  3. Age 18 to 70 years
  4. HCV RNA (Hepatitis C Virus RiboNucleic Acid) = 1,000 IU/mL at screening
  5. Liver biopsy or fibroscan to exclude cirrhosis

Exclusion criteria:

  1. Hepatitis C Virus (HCV) infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
  2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
  3. Decompensated liver disease, or history of decompensated liver disease,
  4. Body weight < 40 or > 125 kg,
  5. Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
  6. Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
  7. Laboratory parameters disorders (thalassemia major, sickle cell anemia or glucose 6 phosphate dehydrogenase deficit)
  8. Hemoglobin < 12 g/dL for women and < 13 g/dL for men
  9. Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection

Sites / Locations

  • 1241.27.0006 Boehringer Ingelheim Investigational Site
  • 1241.27.0005 Boehringer Ingelheim Investigational Site
  • 1241.27.0004 Boehringer Ingelheim Investigational Site
  • 1241.27.0003 Boehringer Ingelheim Investigational Site
  • 1241.27.0001 Boehringer Ingelheim Investigational Site
  • 1241.27.0200 Boehringer Ingelheim Investigational Site
  • 1241.27.0600 Boehringer Ingelheim Investigational Site
  • 1241.27.0700 Boehringer Ingelheim Investigational Site
  • 1241.27.0400 Boehringer Ingelheim Investigational Site
  • 1241.27.0100 Boehringer Ingelheim Investigational Site
  • 1241.27.0300 Boehringer Ingelheim Investigational Site
  • 1241.27.0500 Boehringer Ingelheim Investigational Site
  • 1241.27.4901 Boehringer Ingelheim Investigational Site
  • 1241.27.4907 Boehringer Ingelheim Investigational Site
  • 1241.27.4903 Boehringer Ingelheim Investigational Site
  • 1241.27.4906 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

Effect of BI 207127 on BI 201335, the effect of BI 201335 and dual oral direct acting antiviral (DAAs) on caffeine, tolbutamide and midazolam

Effect of BI 201335 on BI 207127, the effect of BI 207127 and metabolites and dual oral DAAs on caffeine, tolbutamide and midazolam

Effect of Dual oral DAAs on tenofovir

Effect of BI 201335 and BI 207127 at 600 mg b.i.d. on caffeine, tolbutamide and midazolam

Effect of BI 201335 and BI 207127 on raltegravir

Outcomes

Primary Outcome Measures

Cmax of Faldaprevir (BI 201335)
Maximum concentration of an analyte in plasma
C24hr of Faldaprevir (BI 201335)
Concentration of an analyte in plasma at 24 hours
Area Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours
Cmax of Deleobuvir (BI 207127)
Maximum concentration of an analyte in plasma
C6hr of Deleobuvir (BI 207127)
Concentration of an analyte in plasma at 6 hours
AUC 0-6hr of Deleobuvir (BI 207127)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours
Cmax of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
Maximum concentration of an analyte in plasma
C6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
Concentration of an analyte in plasma at 6 hours
AUC 0-6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours
Cmax of Deleobuvir Reduction Metabolite CD 6168
Maximum concentration of an analyte in plasma
C6hr of Deleobuvir Reduction Metabolite CD 6168
Concentration of an analyte in plasma at 6 hours
AUC 0-6hr of Deleobuvir Reduction Metabolite CD 6168
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours
Cmax of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
Maximum concentration of an analyte in plasma
C6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
Concentration of an analyte in plasma at 6 hours
AUC 0-6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours
Cmax of Caffeine
Maximum concentration of an analyte in plasma
AUC 0-infinity of Caffeine
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Cmax of Tolbutamide
Maximum concentration of an analyte in plasma
AUC 0-infinity of Tolbutamide
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Cmax of Midazolam
Maximum concentration of an analyte in plasma
AUC 0-infinity of Midazolam
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Cmax of 1-OH-Midazolam (1-hydroxy-midazolam)
Maximum concentration of an analyte in plasma
AUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Cmax of Tenofovir
Maximum concentration of an analyte in plasma.
C24hr of Tenofovir
Concentration of an analyte in plasma at 24 hours.
AUC 0-24hr of Tenofovir
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours.
Cmax of Raltegravir
Maximum concentration of an analyte in plasma.
C12hr of Raltegravir
Concentration of an analyte in plasma at 12 hours.
AUC 0-12hr of Raltegravir
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 hours.

Secondary Outcome Measures

Number of Participants With Sustained Virological Response (SVR12)
Sustained virologic response (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) undetectable at 12 weeks after the end of treatment. SVR12 was analyzed in a descriptive manner using frequency of participants who achieved SVR12.

Full Information

First Posted
February 1, 2012
Last Updated
May 4, 2016
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01525628
Brief Title
Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients
Official Title
A Multi-centre, Open Label, Parallel Group Trial to Evaluate the Pharmacokinetic Interactions Between BI 207127 (600 mg t.i.d. or 600 mg b.i.d.) and BI 201335 (120 mg q.d.) Given in Combination With Ribavirin for 24 Weeks, and Their Combined Effect on the Pharmacokinetics of Tenofovir, Raltegravir, Caffeine (the Probe Drug Substrate for CYP1A2), Tolbutamide (the Probe Drug Substrate for CYP2C9) and Midazolam (the Probe Drug Substrate for CYP3A4) in Treatment naïve Patients and Prior Treatment Relapse or Partial Responder Patients With Genotype 1 Chronic Hepatitis C Infection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
To evaluate the drug-drug interactions between BI 201335 and BI 207127 as well as their combined effect on CYP probe drug substrates and on tenofovir and raltegravir in treatment naive or prior treatment relapse patients with chronic hepatitis C infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Effect of BI 207127 on BI 201335, the effect of BI 201335 and dual oral direct acting antiviral (DAAs) on caffeine, tolbutamide and midazolam
Arm Title
Group B
Arm Type
Experimental
Arm Description
Effect of BI 201335 on BI 207127, the effect of BI 207127 and metabolites and dual oral DAAs on caffeine, tolbutamide and midazolam
Arm Title
Group C
Arm Type
Experimental
Arm Description
Effect of Dual oral DAAs on tenofovir
Arm Title
Group D
Arm Type
Experimental
Arm Description
Effect of BI 201335 and BI 207127 at 600 mg b.i.d. on caffeine, tolbutamide and midazolam
Arm Title
Group E
Arm Type
Experimental
Arm Description
Effect of BI 201335 and BI 207127 on raltegravir
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Description
CYP3A probe drug
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
HCV protease inhibitor
Intervention Type
Drug
Intervention Name(s)
tenofovir
Intervention Description
nucleoside analogue
Intervention Type
Drug
Intervention Name(s)
caffeine
Intervention Description
CYP1A2 probe drug
Intervention Type
Drug
Intervention Name(s)
tolbutamide
Intervention Description
CYP2C9 probe drug
Intervention Type
Drug
Intervention Name(s)
tolbutamide
Intervention Description
CYP2C9 probe drug
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Description
CYP3A probe drug
Intervention Type
Drug
Intervention Name(s)
caffeine
Intervention Description
CYP1A2 probe drug
Intervention Type
Drug
Intervention Name(s)
pegylated interferon
Intervention Description
HCV treatment
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
HCV protease inhibitor
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
HCV protease inhibitor
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
HCV polymerase inhibitor
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
HCV polymerase inhibitor
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
HCV protease inhibitor
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
HCV polymerase inhibitor
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
HCV treatment
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
HCV treatment
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
HCV treatment
Intervention Type
Drug
Intervention Name(s)
pegylated interferon
Intervention Description
HCV treatment
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
HCV treatment
Intervention Type
Drug
Intervention Name(s)
caffeine
Intervention Description
CYP1A2 probe drug
Intervention Type
Drug
Intervention Name(s)
tolbutamide
Intervention Description
CYP2C9 probe drug
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
HCV polymerase inhibitor
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Description
CYP3A probe drug
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
HCV protease inhibitor
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
HCV polymerase inhibitor
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
HCV treatment
Primary Outcome Measure Information:
Title
Cmax of Faldaprevir (BI 201335)
Description
Maximum concentration of an analyte in plasma
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
C24hr of Faldaprevir (BI 201335)
Description
Concentration of an analyte in plasma at 24 hours
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
Area Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours
Description
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
Cmax of Deleobuvir (BI 207127)
Description
Maximum concentration of an analyte in plasma
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
C6hr of Deleobuvir (BI 207127)
Description
Concentration of an analyte in plasma at 6 hours
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
AUC 0-6hr of Deleobuvir (BI 207127)
Description
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
Cmax of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
Description
Maximum concentration of an analyte in plasma
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
C6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
Description
Concentration of an analyte in plasma at 6 hours
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
AUC 0-6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
Description
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
Cmax of Deleobuvir Reduction Metabolite CD 6168
Description
Maximum concentration of an analyte in plasma
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
C6hr of Deleobuvir Reduction Metabolite CD 6168
Description
Concentration of an analyte in plasma at 6 hours
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
AUC 0-6hr of Deleobuvir Reduction Metabolite CD 6168
Description
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
Cmax of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
Description
Maximum concentration of an analyte in plasma
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
C6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
Description
Concentration of an analyte in plasma at 6 hours
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
AUC 0-6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
Description
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Title
Cmax of Caffeine
Description
Maximum concentration of an analyte in plasma
Time Frame
5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Title
AUC 0-infinity of Caffeine
Description
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Time Frame
5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Title
Cmax of Tolbutamide
Description
Maximum concentration of an analyte in plasma
Time Frame
5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Title
AUC 0-infinity of Tolbutamide
Description
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Time Frame
5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Title
Cmax of Midazolam
Description
Maximum concentration of an analyte in plasma
Time Frame
5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Title
AUC 0-infinity of Midazolam
Description
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Time Frame
5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Title
Cmax of 1-OH-Midazolam (1-hydroxy-midazolam)
Description
Maximum concentration of an analyte in plasma
Time Frame
5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Title
AUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam)
Description
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Time Frame
5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Title
Cmax of Tenofovir
Description
Maximum concentration of an analyte in plasma.
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17
Title
C24hr of Tenofovir
Description
Concentration of an analyte in plasma at 24 hours.
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17
Title
AUC 0-24hr of Tenofovir
Description
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours.
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17
Title
Cmax of Raltegravir
Description
Maximum concentration of an analyte in plasma.
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17
Title
C12hr of Raltegravir
Description
Concentration of an analyte in plasma at 12 hours.
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17
Title
AUC 0-12hr of Raltegravir
Description
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 hours.
Time Frame
PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17
Secondary Outcome Measure Information:
Title
Number of Participants With Sustained Virological Response (SVR12)
Description
Sustained virologic response (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) undetectable at 12 weeks after the end of treatment. SVR12 was analyzed in a descriptive manner using frequency of participants who achieved SVR12.
Time Frame
12 weeks post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening Treatment naive or confirmed prior treatment relapse or partial response following treatment with interferon and ribavirin Age 18 to 70 years HCV RNA (Hepatitis C Virus RiboNucleic Acid) = 1,000 IU/mL at screening Liver biopsy or fibroscan to exclude cirrhosis Exclusion criteria: Hepatitis C Virus (HCV) infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection Evidence of acute or chronic liver disease due to causes other than chronic HCV infection, Decompensated liver disease, or history of decompensated liver disease, Body weight < 40 or > 125 kg, Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study Laboratory parameters disorders (thalassemia major, sickle cell anemia or glucose 6 phosphate dehydrogenase deficit) Hemoglobin < 12 g/dL for women and < 13 g/dL for men Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1241.27.0006 Boehringer Ingelheim Investigational Site
City
La Mesa
State/Province
California
Country
United States
Facility Name
1241.27.0005 Boehringer Ingelheim Investigational Site
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
1241.27.0004 Boehringer Ingelheim Investigational Site
City
Marlton
State/Province
New Jersey
Country
United States
Facility Name
1241.27.0003 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1241.27.0001 Boehringer Ingelheim Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
1241.27.0200 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1241.27.0600 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1241.27.0700 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1241.27.0400 Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
1241.27.0100 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
1241.27.0300 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
1241.27.0500 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1241.27.4901 Boehringer Ingelheim Investigational Site
City
Frankfurt am Main
Country
Germany
Facility Name
1241.27.4907 Boehringer Ingelheim Investigational Site
City
Köln
Country
Germany
Facility Name
1241.27.4903 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
1241.27.4906 Boehringer Ingelheim Investigational Site
City
Mainz
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/
Description
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Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients

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