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

Phase 1

Completed

• Conditions: Healthy
• Interventions: 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

• Registration Number: NCT01841112
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-22
• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-26
• Primary Completion: 2013-07-18
• Study Completion: 2013-07-18
• Results First Submitted: 2023-08-10
• Results First Submitted QC: 2024-05-23
• Results First Posted: 2024-05-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 65

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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
BI-409306 25 milligram (mg) SD	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
BI-409306 50 mg SD	BI-409306 50 mg SD	Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
BI-409306 100 mg SD	BI-409306 100 mg SD	Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
BI-409306 100 mg MDBI-409306 100 mg SD & MD	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. 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.

Primary Outcome Measures

Name	Time	Method
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.	Percentage (%) of subjects with drug-related adverse events (AEs).

Secondary Outcome Measures

Name	Time	Method
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.	Maximum measured concentration of a single dose of BI 409306 in plasma (Cmax).
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 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 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.	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).
Maximum Measured Concentration of the Metabolite CD 13896 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.	Maximum measured concentration of the metabolite CD 13896 in plasma (Cmax) after single administration of BI 409306.
Maximum Measured Concentration of the Metabolite CD 14084 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.	Maximum measured concentration of the metabolite CD 14084 in plasma (Cmax) after single administration of BI 409306.
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)	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) after single administration of BI 409306.
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)	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) after single administration of BI 409306.
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).	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) after single administration of BI 409306.
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).	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) after single administration of BI 409306.

Trial Locations

Locations (1)

1289.4.8201 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of