Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers

Open, Randomised, Two-way Crossover Study to Assess the Effect of a High Fat, High Caloric Meal on the Pharmacokinetics of BI 409306, Followed by a Fixed Sequence Period to Investigate the Pharmacokinetics of BI 409306 After a Single Oral Dose Given at Bed Time in Healthy Male and Female Volunteers

To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the pharmacokinetics of BI 409306 when given at bed time.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 409306

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • 1289.22.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. Healthy male and female volunteers
2. Age 18 (incl.) to 50 (incl.) years
3. Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2

Exclusion criteria:

1. Any evidence of a clinically relevant concomitant disease
2. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)
6. History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis.
7. Positive pregnancy test
8. No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 409306 fasted; Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition.	Drug: BI 409306; film-coated tablet
Experimental: BI 409306 fed; Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition.	Drug: BI 409306; film-coated tablet
Experimental: BI 409306 at bed-time; Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time.	Drug: BI 409306; film-coated tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Measured Concentration of BI 409306 in Plasma (Cmax)	Cmax is the maximum measured concentration of BI 409306 in plasma. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C	Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h
Area Under the Concentration-time Curve of BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-tz)	AUC0-tz is the area under the concentration-time curve of the BI 409306 in plasma from time 0 to time of last quantifiable data point. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C	Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)	AUC0-infinity is the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C.	Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Investigators: Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Publications and helpful links

General Publications

• Unable to connect to PubMed to validate , last attempt on November 19, 2014 at 10:17 AM EST

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2014
• Primary Completion (Actual): October 31, 2014
• Study Completion (Actual): October 31, 2014

Study Registration Dates

• First Submitted: August 20, 2014
• First Submitted That Met QC Criteria: August 20, 2014
• First Posted (Estimated): August 21, 2014

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Phosphodiesterase Inhibitors; BI 409306
• Other Study ID Numbers: 1289.22; 2014-001934-28 (EudraCT Number: EudraCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency