Safety, Tolerability and Pharmacokinetics of BI 409306 Tablets in Healthy Asian Male Volunteers

Safety, Tolerability and Pharmacokinetics of Single Oral Doses of BI 409306 (Tablet) in Healthy Chinese and Japanese Male Volunteers and Multiple Oral Doses of BI 409306 (Tablet) in Healthy Japanese Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306 tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in the study protocol.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BI-409306 25 milligram (mg) SD; Drug: BI-409306 50 mg SD; Drug: BI-409306 100 mg SD; Drug: BI-409306 100 mg MD

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • 1289.4.8201 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. Healthy male Chinese and Japanese volunteers
2. Age between 20 and 45 years
3. BMI between 18.5 and 25 kg/m2 (Body Mass Index)
4. Known genotype as specified in the study protocol
5. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

1. Any deviation from healthy condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment	Drug: Placebo; Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
Experimental: BI-409306 25 milligram (mg) SD; Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1	Drug: BI-409306 25 milligram (mg) SD; Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
Experimental: BI-409306 50 mg SD; Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1	Drug: BI-409306 50 mg SD; Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
Experimental: BI-409306 100 mg SD; Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1	Drug: BI-409306 100 mg SD; Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
Experimental: BI-409306 100 mg MDBI-409306 100 mg SD & MD; Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first does of multipled dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.	Drug: BI-409306 100 mg MD; Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage (%) of Subjects With Drug-related Adverse Events (AEs)	Percentage (%) of subjects with drug-related adverse events (AEs).	From first drug administration until 11 days after last dose of study medication, up to 18 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Measured Concentration of a Single Dose of BI 409306 in Plasma (Cmax)	Maximum measured concentration of a single dose of BI 409306 in plasma (Cmax).	PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)	Area under the concentration-time curve of a single dose of BI 409306 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).	PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz)	Area under the concentration-time curve of a single dose of BI 409306 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz).	PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Maximum Measured Concentration of the Metabolite CD 13896 in Plasma (Cmax)	Maximum measured concentration of the metabolite CD 13896 in plasma (Cmax) after single administration of BI 409306.	PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Maximum Measured Concentration of the Metabolite CD 14084 in Plasma (Cmax)	Maximum measured concentration of the metabolite CD 14084 in plasma (Cmax) after single administration of BI 409306.	PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)	Area under the concentration-time curve of the metabolite CD 13896 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) after single administration of BI 409306.	PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)	Area under the concentration-time curve of the metabolite CD 14084 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) after single administration of BI 409306.	PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz).	Area under the concentration-time curve of the metabolite CD 13896 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz) after single administration of BI 409306.	PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz).	Area under the concentration-time curve of the metabolite CD 14084 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz) after single administration of BI 409306.	PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2013
• Primary Completion (Actual): July 18, 2013
• Study Completion (Actual): July 18, 2013

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: April 24, 2013
• First Posted (Estimated): April 26, 2013

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 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: 1289.4

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