NCT01694706

Brief Summary

The primary objective of this trial is to investigate the effect of food and of gastric pH increase on the relative bioavailability of faldaprevir.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2012

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

September 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

July 30, 2015

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

September 24, 2012

Results QC Date

July 3, 2015

Last Update Submit

July 3, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)

    Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 extrapolated to infinity In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

    1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration

  • Faldaprevir: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of the faldaprevir in plasma In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

    1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration

Secondary Outcomes (1)

  • Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)

    1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration

Study Arms (3)

Reference

EXPERIMENTAL

faldaprevir medium, fasted

Drug: faldaprevir

Test 1

ACTIVE COMPARATOR

faldaprevir medium, fed

Drug: faldaprevir

Test 2

ACTIVE COMPARATOR

faldaprevir medium + omeprazole medium

Drug: omeprazoleDrug: faldaprevir

Interventions

faldaprevirDRUG

medium dose of faldaprevir

Test 1
omeprazoleDRUG

medium dose of omeprazole

Test 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Healthy male and female subjects

You may not qualify if:

  • \. Any relevant deviation from healthy condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1220.59.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Interventions

faldaprevirOmeprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

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
Yes

Study Design

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

Study Record Dates

First Submitted

September 24, 2012

First Posted

September 27, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 30, 2015

Results First Posted

July 30, 2015

Record last verified: 2015-07

Locations

DE(1)