NCT01637922

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

August 3, 2015

Completed
Last Updated

August 3, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

July 9, 2012

Results QC Date

July 3, 2015

Last Update Submit

July 3, 2015

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (15)

  • R-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.

    These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

  • R-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.

    These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

  • R-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.

    These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

  • S-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9

    These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

  • S-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9

    These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

  • S-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9

    These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

  • Buprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.

    These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

  • Buprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.

    These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

  • Buprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.

    These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

  • Norbuprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.

    These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

  • Norbuprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.

    These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

  • Norbuprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.

    These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

  • Naloxone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.

    These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

  • Naloxone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.

    These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

  • Naloxone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.

    These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose

    0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9

Secondary Outcomes (2)

  • Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Objective Opiate Withdrawal Scale (OOWS)-Change From Baseline

    Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment

  • Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Subjective Opiate Withdrawal Scale (SOWS)-Change From Baseline

    Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment

Study Arms (2)

Methadone group

ACTIVE COMPARATOR

patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day

Drug: BI 201335

Buprenorphine

ACTIVE COMPARATOR

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day.

Drug: BI 201335

Interventions

BI 201335DRUG

BI 201335 for 9 days

Methadone group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • stable dose of either methadone or buprenorphine/naloxone for 30 days for opioid maintenance therapy.
  • Male and female volunteers with a body mass index (BMI) = 18.5 and \< 32 with a minimum weight of 50kg.

You may not qualify if:

  • any other significant medical illness of clinical significance.
  • history of rash or photosensitivity
  • chronic or acute infections including HIV, hepatitis B and hepatitis C.
  • history of allergy considered significant for this study
  • intake of any other medications except for methadone or buprenorphine/naloxone.
  • QTc on electrocardiogram (ECG) \> 470.
  • use of any other investigational drug within 30 days of the study.
  • drug or alcohol abuse (other than the defined opioid maintenance therapy with either methadone or buprenorphine/naloxone)
  • blood donation of more than 100mL within four weeks of the trial.
  • excessive physical activities one week prior to and during the trial.
  • any clinically relevant laboratory value.
  • concomitant use of any food product known to alter P450 or P-gp activity such as grapefruit juice, seville oranges and St. John's Wort.
  • inadequate venous access
  • For women of childbearing potential:
  • pregnancy or planning to become pregnant within 3 months of the trial
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

1220.57.0001 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

1220.57.0002 Boehringer Ingelheim Investigational Site

Overland Park, Kansas, United States

Location

1220.57.0003 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

Related Publications (1)

  • Joseph D, Schobelock MJ, Riesenberg RR, Vince BD, Webster LR, Adeniji A, Elgadi M, Huang F. Effect of steady-state faldaprevir on the pharmacokinetics of steady-state methadone and buprenorphine-naloxone in subjects receiving stable addiction management therapy. Antimicrob Agents Chemother. 2015 Jan;59(1):498-504. doi: 10.1128/AAC.04046-14. Epub 2014 Nov 10.

    PMID: 25385094DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

faldaprevir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 11, 2012

Study Start

August 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

August 3, 2015

Results First Posted

August 3, 2015

Record last verified: 2015-07

Locations

US(3)