NCT01371006

Brief Summary

Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when administered together. To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for phase_1 healthy

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3.9 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

June 9, 2011

Results QC Date

July 3, 2015

Last Update Submit

July 3, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • Group A - Efavirenz: Cmax

    Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)

    0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz

  • Group A - Efavirenz: AUC0-∞

    Area under the concentration-time curve of the analyte in plasma over the time interval 0 to infinity of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)

    0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of Efavirenz

  • Group B - Faldaprevir: Cmax,ss

    Maximum plasma concentration at steady state of Faldaprevir calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)

    0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir

  • Group B - Faldaprevir: AUC0-12h,ss

    Area under the concentration-time curve of Faldaprevir at steady state over the time interval 0 to 12h calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)

    0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir

  • Group B - Faldaprevir: C12,ss

    Plasma concentration 12 h after dosing of Faldaprevir at steady state calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)

    0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir

Secondary Outcomes (12)

  • Group A - Faldaprevir: Cmax,ss

    0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir

  • Group A - Faldaprevir: Tmax,ss

    0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir

  • Group A - Faldaprevir: AUC0-12h,ss

    0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir

  • Group A - Faldaprevir: C12,ss

    0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir

  • Group A - Efavirenz: Tmax

    0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Efavirenz

  • +7 more secondary outcomes

Study Arms (2)

BI201335 low dose Efavirenz

EXPERIMENTAL

low dose Efavirenz

Drug: low dose

BI201335 high dose Efavirenz

EXPERIMENTAL

normal dose Efavirenz

Drug: low doseDrug: normal dose

Interventions

low doseDRUG

efavirenz single dosing once daily

BI201335 high dose Efavirenz
normal doseDRUG

efavirenz once daily

BI201335 high dose Efavirenz

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers age 18- 55 BMI (Body Mass Index) 18.5 - 29.9

You may not qualify if:

  • Any finding on medical examination and ECG (Electrocardiography) deviating from normal
  • Active diseases
  • History of photosensitivity or rash

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1220.20.41001 Boehringer Ingelheim Investigational Site

Basel, Switzerland

Location

MeSH Terms

Interventions

Contraceptives, Oral

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

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

June 9, 2011

First Posted

June 10, 2011

Study Start

June 1, 2011

Primary Completion

September 1, 2011

Last Updated

August 3, 2015

Results First Posted

August 3, 2015

Record last verified: 2015-07

Locations

CH(1)