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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 409306; Drug: Placebo

• Registration Number: NCT01611311
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-01
• Study First Submitted: 2012-05-22
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-04
• Primary Completion: 2012-08-01
• Study Completion: 2012-08-01
• Status Verified: 2023-08
• Results First Submitted: 2023-08-10
• Results First Submitted QC: 2023-08-10
• Last Update Submitted: 2023-08-10
• Results First Posted: 2024-03-08
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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
BI 409306 - 25 milligram (mg) (Young subjects)	BI 409306	Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
BI 409306 - 25 milligram (mg) (Elderly subjects)	BI 409306	Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
BI 409306 - 50 milligram (mg) (Elderly subjects)	BI 409306	Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
Placebo (Young subjects)	Placebo	Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
BI 409306 - 50 milligram (mg) (Young subjects)	BI 409306	Young 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	Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests	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 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.
Percentage of Subjects With Investigator Defined Drug-Related Adverse Events	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 investigator defined drug-related Adverse Events (AEs).

Secondary Outcome Measures

Name	Time	Method
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.	Area under the concentration-time curve of the BI 409306 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).
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 (Cmax).
Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,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 409306in Plasma at Steady State (Tmax,ss).
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.	Maximum measured concentration of the BI 409306 in plasma at steady state (Cmax, ss).
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 from 0 to 24 hours (AUC0-24).
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.	Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (tmax).

Trial Locations

Locations (1)

1289.17.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Neuss, Germany