NCT01703858

Brief Summary

The objective of the trial is to investigate the relative bioavailability, influence of pantoprazole coadministration and food effect of different oral formulations of BI 113608 in healthy male subjects

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
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

January 20, 2017

Completed
Last Updated

January 20, 2017

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

October 8, 2012

Results QC Date

November 23, 2016

Last Update Submit

November 23, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

    Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).

    PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.

  • Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)

    Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).

    PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.

Secondary Outcomes (1)

  • Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)

    PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.

Study Arms (5)

1 BI 113608

ACTIVE COMPARATOR

powder in the bottle for oral solution, oral administration with 240 mL water

Drug: BI 113608 PIB

2 BI 113608

EXPERIMENTAL

conventional tablet formulation

Drug: BI 113608

3 BI 113608

EXPERIMENTAL

conventional tablet formulation, fed

Drug: BI 113608

4 BI 113608

EXPERIMENTAL

conventional tablet after pantoprazole administration

Drug: pantoprazole 40 mg STADADrug: BI 113608

5 BI 113608

EXPERIMENTAL

conventional tablet formulation, fasted, 0:30 min before fat breakfast

Drug: BI 113608

Interventions

BI 113608 PIBDRUG

powder for oral solution

1 BI 113608
BI 113608DRUG

conventional tablet formulation

2 BI 113608
pantoprazole 40 mg STADADRUG

film-coated tablet

4 BI 113608

Eligibility Criteria

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

You may qualify if:

  • \. healthy male subjects

You may not qualify if:

  • \. Any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1314.3.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Location

MeSH Terms

Interventions

Pantoprazole

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

October 8, 2012

First Posted

October 11, 2012

Study Start

September 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 20, 2017

Results First Posted

January 20, 2017

Record last verified: 2016-11

Locations

DE(1)