NCT01821937

Brief Summary

The aim of the trial is to assess the bioavailability of Faldaprevir soft capsule with single oral dose and multiple oral doses in Chinese subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 2013

Shorter than P25 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

March 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2.3 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

2 months

First QC Date

March 25, 2013

Results QC Date

July 3, 2015

Last Update Submit

July 3, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Cmax,ss (After Multiple Dosing)

    C(max,ss) is defined as maximum measured concentration of Faldaprevir in plasma at steady state over a uniform dosing interval tau.

    Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir

  • AUC(Tau,ss) (After Multiple Dosing)

    AUC(tau,ss) is defined as area under the concentration-time curve of Faldaprevir in plasma at steady state over a uniform dosing interval tau.

    Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir

Secondary Outcomes (4)

  • Cmax (After Single Dosing)

    Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir

  • AUC(0-tz) (After Single Dosing)

    Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir

  • t(1/2,ss) (After Multiple Dosing)

    Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir

  • Tmax,ss (After Multiple Dosing)

    Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir

Study Arms (2)

faldaprevir(high dose)

EXPERIMENTAL

10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose.

Drug: faldaprevir(high dose)

Faldaprevir(low dose)

EXPERIMENTAL

10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose.

Drug: Faldaprevir(low dose)

Interventions

faldaprevir(high dose)DRUG

faldaprevir(high dose) will be taken by 1 day single use and 10 days multiple use. the subjects will be assigned to high dose treatment in random order

faldaprevir(high dose)
Faldaprevir(low dose)DRUG

faldaprevir(low dose) will be taken by 1 day single use and 10 days multiple use. the subjects will be assigned to low dose treatment in random order

Faldaprevir(low dose)

Eligibility Criteria

Age18 Years - 45 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 conditionsAny relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1220.52.86001 Boehringer Ingelheim Investigational Site

Beijing, China

Location

MeSH Terms

Interventions

faldaprevir

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2013

First Posted

April 1, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 3, 2015

Results First Posted

August 3, 2015

Record last verified: 2015-07

Locations

CN(1)