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Completed Phase 1 Interventional Results available

Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone

ClinicalTrials.gov ID: NCT01637922

Public ClinicalTrials.gov record NCT01637922. 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 Sep 2, 2026, 3:56 AM EDT

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

Official title

Effect of Multiple Dosing With BI 201335 on the Safety, Pharmacokinetics and Pharmacodynamics of Steady-state Methadone and Buprenorphine/Naloxone in Subjects on Stable Addiction Management Therapy

Brief summary

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

Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to determine if a drug interaction occurs between BI 201335 and either methadone or buprenorphine/naloxone.

Study identification

NCT ID
NCT01637922
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
34 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 64 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
Jul 31, 2012
Primary completion
Oct 31, 2012
Completion
Oct 31, 2012
Last update posted
Aug 2, 2015

2012

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
1220.57.0001 Boehringer Ingelheim Investigational Site Atlanta Georgia
1220.57.0002 Boehringer Ingelheim Investigational Site Overland Park Kansas
1220.57.0003 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.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01637922, 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 Aug 2, 2015 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01637922 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →