NCT01737996

Brief Summary

The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with faldaprevir in healthy male and female subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 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

November 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 8, 2016

Completed
Last Updated

April 8, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

November 26, 2012

Results QC Date

January 21, 2016

Last Update Submit

March 10, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (15)

  • Number of Healthy Subjects With AEs (Multiple Rising Dose Part)

    Number of healthy subjects with any adverse event (AE) during the on-treatment period.

    From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)

  • AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part)

    Area under the concentration-time curve (AUC) of Deleobuvir over the uniform dosing interval 0 to 12 h (hours) on Day 1 and at steady state on Day 16.

    After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 hours (h) after drug administration in the morning.

  • Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part)

    Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 16.

    After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part)

    Concentration of Deleobuvir at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.

    After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part)

    Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir.

    After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • Cmax and Cmax,ss of CD 6168 (Combined Treatment Part)

    Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir.

    After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part)

    Concentration of CD 6168 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir.

    After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part)

    Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir.

    After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • Cmax and Cmax,ss of BI 208333 (Combined Treatment Part)

    Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir.

    After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part)

    Concentration of BI 208333 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir.

    After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)

    Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir.

    After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part)

    Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir.

    After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)

    Concentration of CD 6168 acylglucuronide at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir.

    After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part)

    Area under the concentration-time curve of Faldaprevir over the uniform dosing interval 0 to 24 h on Day 1 and at steady state on Day 16.

    After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part)

    Maximum measured concentration of Faldaprevir on Day 1 and at steady state on Day 16.

    After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12, 24 h after drug administration in the morning.

Secondary Outcomes (8)

  • AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part)

    After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part)

    After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part)

    After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part)

    After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part)

    After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

  • +3 more secondary outcomes

Study Arms (1)

All patients

EXPERIMENTAL

For the first 9 days patients receive BI 207127 low dose or high dose, then BI 207127 high dose with faldaprevir

Drug: BI 207127 + faldaprevir

Interventions

BI 207127 + faldaprevirDRUG

fixed dose combination

All patients

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 conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1241.35.1 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

MeSH Terms

Interventions

deleobuvirfaldaprevir

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
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
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2012

First Posted

November 30, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 8, 2016

Results First Posted

April 8, 2016

Record last verified: 2016-03

Locations

DE(1)