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.

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

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

Conditions

Hepatitis C, Chronic

Interventions

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 Sep 1, 2026

Open the official record

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

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