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

NCT01841112 | Completed Phase 1 Results

• 1 other identifier: 1289.4
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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)

  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)

  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)

  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)

  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.

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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

BI-409306 25 milligram (mg) SD

EXPERIMENTAL

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

BI-409306 50 mg SD

EXPERIMENTAL

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

BI-409306 100 mg SD

EXPERIMENTAL

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

BI-409306 100 mg MDBI-409306 100 mg SD & MD

EXPERIMENTAL

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

Interventions

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

Placebo

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 25 milligram (mg) SD

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 50 mg SD

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 SD

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

BI-409306 100 mg MDBI-409306 100 mg SD & MD

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \. Any deviation from healthy condition

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1289.4.8201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

Related Links

• Related Info

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: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: April 26, 2013
• Study Start: April 22, 2013
• Primary Completion: July 18, 2013
• Study Completion: July 18, 2013
• Last Updated: June 25, 2024
• Results First Posted: May 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)