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Completed Phase 1 Interventional Results available

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

ClinicalTrials.gov ID: NCT01525628

Public ClinicalTrials.gov record NCT01525628. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jun 25, 2026, 1:16 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 identification

NCT ID
NCT01525628
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
72 participants

Conditions and interventions

Interventions

  • midazolam Drug
  • BI 201335 Drug
  • tenofovir Drug
  • caffeine Drug
  • tolbutamide Drug
  • pegylated interferon Drug
  • BI 207127 Drug
  • ribavirin Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2012
Primary completion
Nov 30, 2013
Completion
Sep 30, 2014
Last update posted
Jun 9, 2016

2012 – 2014

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
1241.27.0006 Boehringer Ingelheim Investigational Site La Mesa California
1241.27.0005 Boehringer Ingelheim Investigational Site Rockville Maryland
1241.27.0004 Boehringer Ingelheim Investigational Site Marlton New Jersey
1241.27.0003 Boehringer Ingelheim Investigational Site Philadelphia Pennsylvania
1241.27.0001 Boehringer Ingelheim Investigational Site Salt Lake City Utah

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01525628, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 9, 2016 · Synced Jun 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01525628 live on ClinicalTrials.gov.

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