Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients
This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01525628
First received: February 1, 2012
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: tenofovir Drug: midazolam Drug: BI 201335 Drug: caffeine Drug: tolbutamide Drug: pegylated interferon Drug: BI 207127 Drug: ribavirin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Tolbutamide
Interferon
Ribavirin
Midazolam hydrochloride
Tenofovir
Tenofovir Disoproxil Fumarate
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Cmax BI 201335 [ Time Frame: Day 9, 17, 38 and 66 ] [ Designated as safety issue: No ]
- C24hr BI 201335 [ Time Frame: Day 9, 17, 38 and 66 ] [ Designated as safety issue: No ]
- AUC 0-24hr BI 201335 [ Time Frame: Day 9, 17, 38 and 66 ] [ Designated as safety issue: No ]
- AUC 0-24h BI 201335 [ Time Frame: Day 9, 17, 38 and 66 ] [ Designated as safety issue: No ]
- Cmax BI 207127 [ Time Frame: Day 9, 17, 38 and 66 ] [ Designated as safety issue: No ]
- C6h BI 207127 [ Time Frame: Day 9, 17, 38 and 66 ] [ Designated as safety issue: No ]
- AUC0-6h BI 207127 [ Time Frame: Day 9, 17, 38 and 66 ] [ Designated as safety issue: No ]
- Cmax Midazolam [ Time Frame: Day 9, 17 and 66 ] [ Designated as safety issue: No ]
- AUC 0-24h Midazolam [ Time Frame: Day 9, 17 and 66 ] [ Designated as safety issue: No ]
- Cmax Caffeine [ Time Frame: Day 9, 17 and 66 ] [ Designated as safety issue: No ]
- AUC 0-24h Caffeine [ Time Frame: Day 9, 17 and 66 ] [ Designated as safety issue: No ]
- Cmax Tenofovir [ Time Frame: Day 9 and 17 ] [ Designated as safety issue: No ]
- C24h Tenofovir [ Time Frame: Day 9 and 17 ] [ Designated as safety issue: No ]
- AUC 0-24hr Tenofovir [ Time Frame: Day 9 and 17 ] [ Designated as safety issue: No ]
- Cmax Raltegravir [ Time Frame: Day 9 and 17 ] [ Designated as safety issue: No ]
- C12h Raltegravir [ Time Frame: Day 9 and 17 ] [ Designated as safety issue: No ]
- AUC 0-12h Raltegravir [ Time Frame: Day 9 and 17 ] [ Designated as safety issue: No ]
- C12 hr BI 207127 [ Time Frame: Day 9, 17, 38 and 66 ] [ Designated as safety issue: No ]
- AUC 0-12 hr BI 207127 [ Time Frame: Day 9, 17, 38 and 66 ] [ Designated as safety issue: No ]
- Cmax Tolbutamide [ Time Frame: Day 9, 17 and 66 ] [ Designated as safety issue: No ]
- AUC 0-24 hr Tolbutamide [ Time Frame: Day 9, 17 and 66 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Sustained Virological Response [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 93 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group D
Effect of BI 201335 and BI 207127 at 600 mg b.i.d. on caffeine, tolbutamide and midazolam
|
Drug: midazolam
CYP3A probe drug
Drug: BI 201335
HCV protease inhibitor
Drug: BI 207127
HCV polymerase inhibitor
Drug: ribavirin
HCV treatment
Drug: caffeine
CYP1A2 probe drug
Drug: tolbutamide
CYP2C9 probe drug
|
|
Experimental: Group E
Effect of BI 201335 and BI 207127 on raltegravir
|
Drug: BI 201335
HCV protease inhibitor
Drug: ribavirin
HCV treatment
Drug: BI 207127
HCV polymerase inhibitor
|
|
Experimental: Group A
Effect of BI 207127 on BI 201335, the effect of BI 201335 and dual oral direct acting antiviral (DAAs) on caffeine, tolbutamide and midazolam
|
Drug: tolbutamide
CYP2C9 probe drug
Drug: midazolam
CYP3A probe drug
Drug: caffeine
CYP1A2 probe drug
Drug: BI 201335
HCV protease inhibitor
Drug: pegylated interferon
HCV treatment
Drug: BI 207127
HCV polymerase inhibitor
Drug: ribavirin
HCV treatment
|
|
Experimental: Group B
Effect of BI 201335 on BI 207127, the effect of BI 207127 and metabolites and dual oral DAAs on caffeine, tolbutamide and midazolam
|
Drug: BI 201335
HCV protease inhibitor
Drug: caffeine
CYP1A2 probe drug
Drug: tolbutamide
CYP2C9 probe drug
Drug: pegylated interferon
HCV treatment
Drug: ribavirin
HCV treatment
Drug: BI 207127
HCV polymerase inhibitor
Drug: midazolam
CYP3A probe drug
|
|
Experimental: Group C
Effect of Dual oral DAAs on tenofovir
|
Drug: tenofovir
nucleoside analogue
Drug: BI 207127
HCV polymerase inhibitor
Drug: ribavirin
HCV treatment
Drug: BI 201335
HCV protease inhibitor
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525628
Contacts
| Contact: Boehringer Ingelheim Call Center | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Locations
| United States, Arkansas | |
| 1241.27.0007 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Little Rock, Arkansas, United States | |
| United States, California | |
| 1241.27.0006 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| La Mesa, California, United States | |
| United States, Georgia | |
| 1241.27.0002 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Atlanta, Georgia, United States | |
| United States, Maryland | |
| 1241.27.0005 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Rockville, Maryland, United States | |
| United States, New Jersey | |
| 1241.27.0004 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Marlton, New Jersey, United States | |
| United States, Pennsylvania | |
| 1241.27.0003 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Philadelphia, Pennsylvania, United States | |
| United States, Utah | |
| 1241.27.0001 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Salt Lake City, Utah, United States | |
| Canada, British Columbia | |
| 1241.27.0200 Boehringer Ingelheim Investigational Site | Recruiting |
| Vancouver, British Columbia, Canada | |
| 1241.27.0700 Boehringer Ingelheim Investigational Site | Recruiting |
| Vancouver, British Columbia, Canada | |
| 1241.27.0600 Boehringer Ingelheim Investigational Site | Recruiting |
| Vancouver, British Columbia, Canada | |
| 1241.27.0400 Boehringer Ingelheim Investigational Site | Recruiting |
| Victoria, British Columbia, Canada | |
| Canada, Ontario | |
| 1241.27.0100 Boehringer Ingelheim Investigational Site | Recruiting |
| London, Ontario, Canada | |
| 1241.27.0300 Boehringer Ingelheim Investigational Site | Recruiting |
| Ottawa, Ontario, Canada | |
| Canada, Quebec | |
| 1241.27.0500 Boehringer Ingelheim Investigational Site | Recruiting |
| Montreal, Quebec, Canada | |
| Germany | |
| 1241.27.4902 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Berlin, Germany | |
| 1241.27.4901 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Frankfurt am Main, Germany | |
| 1241.27.4905 Boehringer Ingelheim Investigational Site | Recruiting |
| Hannover, Germany | |
| 1241.27.4907 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Köln, Germany | |
| 1241.27.4903 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Leipzig, Germany | |
| 1241.27.4906 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Mainz, Germany | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01525628 History of Changes |
| Other Study ID Numbers: | 1241.27, 2012-004102-10 |
| Study First Received: | February 1, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Canada: Health Canada Germany: United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Caffeine Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Midazolam |
Tenofovir Tenofovir disoproxil Interferons Ribavirin Tolbutamide Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Purinergic P1 Receptor Antagonists Purinergic Antagonists |
ClinicalTrials.gov processed this record on May 21, 2013