Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306

NCT01611311 | Completed Phase 1 Results

• 2 other identifiers: 1289.172012-000052-34
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy young and elderly male and female volunteers following oral administration of repeated rising doses, given once daily over 14 days to young healthy genotyped and elderly healthy male/female volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects With Investigator Defined Drug-Related Adverse Events

  Percentage of subjects with investigator defined drug-related Adverse Events (AEs).

  From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days

• Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests

  Percentage of subjects with clinically relevant abnormalities in Vital signs,12-lead electrocardiogram (ECG), Clinical laboratory tests (hematology, clinical chemistry, and urinalysis), Physical examination, Suicidality assessment, Color discrimination test, Visual acuity test.

  From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days

Secondary Outcomes (6)

• Maximum Measured Concentration of the BI 409306 in Plasma (Cmax)

  PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.

• Maximum Measured Concentration of the BI 409306 in Plasma at Steady State (Cmax, ss)

  PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.

• Area Under the Concentration-time Curve of the BI 409306 in Plasma From 0 to 24 Hours (AUC0-24)

  PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.

• Area Under the Concentration-time Curve of the BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)

  PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.

• Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (Tmax)

  PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.

Study Arms (6)

Placebo (Young subjects)

PLACEBO COMPARATOR

Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days

Drug: Placebo

BI 409306 - 25 milligram (mg) (Young subjects)

EXPERIMENTAL

Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Drug: BI 409306

BI 409306 - 50 milligram (mg) (Young subjects)

EXPERIMENTAL

Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Drug: BI 409306

Placebo (Elderly subjects)

PLACEBO COMPARATOR

Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days

Drug: Placebo

BI 409306 - 25 milligram (mg) (Elderly subjects)

EXPERIMENTAL

Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Drug: BI 409306

BI 409306 - 50 milligram (mg) (Elderly subjects)

EXPERIMENTAL

Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Drug: BI 409306

Interventions

BI 409306 DRUG

Film-coated tablet

BI 409306 - 25 milligram (mg) (Elderly subjects); BI 409306 - 25 milligram (mg) (Young subjects); BI 409306 - 50 milligram (mg) (Elderly subjects); BI 409306 - 50 milligram (mg) (Young subjects)

Placebo DRUG

Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Placebo (Elderly subjects); Placebo (Young subjects)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Healthy male/female subjects

You may not qualify if:

• \. Any relevant deviation from healthy conditions

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1289.17.1 Boehringer Ingelheim Investigational Site

Neuss, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

BI 409306

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: May 22, 2012
• First Posted: June 4, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 8, 2024
• Results First Posted: March 8, 2024

Record last verified: 2023-08

Locations

DE (1)