Skip to main content
OpenTrials
Completed

NCT Number: NCT01841112

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1289.4.8201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any deviation from healthy condition

Treatment and study plan

Placebo

Drug

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

Drug

Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

BI-409306 50 mg SD

Drug

Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

BI-409306 100 mg SD

Drug

Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

BI-409306 100 mg MD

Drug

Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9

Primary outcomes

  1. Percentage (%) of Subjects With Drug-related Adverse Events (AEs)

    Time frame: 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 outcomes

  1. Maximum Measured Concentration of a Single Dose of BI 409306 in Plasma (Cmax)

    Time frame: 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).

  2. 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)

    Time frame: 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).

  3. 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)

    Time frame: 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).

  4. Maximum Measured Concentration of the Metabolite CD 13896 in Plasma (Cmax)

    Time frame: 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.

  5. Maximum Measured Concentration of the Metabolite CD 14084 in Plasma (Cmax)

    Time frame: 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.

  6. 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)

    Time frame: 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.

  7. 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)

    Time frame: 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.

  8. 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).

    Time frame: 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.

  9. 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).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 26, 2013
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.