Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses

Phase 1

Completed

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

• Registration Number: NCT01505894
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial was to investigate safety and tolerability of multiple doses of BI 409306 in healthy young and elderly volunteers.

The secondary objective was to explore the pharmacokinetics and pharmacodynamics of multiple doses of BI 409306 in healthy young and elderly volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-09
• Primary Completion: 2012-07-01
• Study Completion: 2012-07-01
• 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: 83

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 409306 50 mg - Young Subjects BID	BI 409306	50 mg of BI 409306 were administered in young subjects twice daily (BID).
BI 409306 50 mg - Elderly Subjects QD	BI 409306	50 mg of BI 409306 were administered in elderly subjects once daily
BI 409306 100 mg - Young Subjects QD	BI 409306	100 mg of BI 409306 were administered in young subjects once daily (QD).
BI 409306 100 mg - Elderly Subjects QD	BI 409306	100 mg of BI 409306 were administered in elderly subjects once daily (QD).
Placebo - Young Subjects	Placebo	Placebo - Young Subjects
Placebo - Elderly Subjects	Placebo	Placebo - Elderly Subjects
BI 409306 25 mg - Young Subjects QD	BI 409306	25 milligram (mg) of BI 409306 were administered in young subjects once daily (QD).
BI 409306 25 mg - Elderly Subjects QD	BI 409306	25 mg of BI 409306 were administered in elderly subjects once daily (QD).
BI 409306 50 mg - Young Subjects QD	BI 409306	50 mg of BI 409306 were administered in young subjects once daily (QD).

Primary Outcome Measures

Name	Time	Method
Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group	From first drug administration until the end-of-trial examination, up to 28 days.	An adverse event is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a subject in a clinical investigation who received a pharmaceutical product.
Number of Participants With Abnormal Findings in Color Discrimination Test	From first drug administration until the end-of-trial examination, up to 28 days.	Color vision was tested using the Ishihara test for color deficiency. The test consisted of a number of plates, called Ishihara plates, each of which contains a circle of dots of differing color and size. Within the pattern some dots form a number visible to those with normal color vision and invisible, or difficult to see, for those with a color vision deficiency. Participants with abnormal findings in color discrimination test are participants, who are not able to recognize the sign on the presented table.
Number of Participants With Abnormal Findings in Visual Acuity Test	From first drug administration until the end-of-trial examination, up to 28 days.	Snellen chart was used to measure visual acuity. It measures the smallest line that a participant was able to read at a distance of 3 meter. Participants with abnormal findings in visual acuity test are participants, who are not able to recognize the letters on the line 3.
Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment	From first drug administration until the end-of-trial examination, up to 28 days.	Number of participants with clinically relevant abnormal findings, as judged by investigator and reported as adverse event (AE), in vital signs (blood pressure, pulse rate, orthostatic test), 12-lead electrocardiogram (ECG), clinical laboratory tests (haematology, clinical chemistry, urinalysis) , physical examination, ophthalmological examination and suicidality assessment.
Number of Participants Per Category of Global Tolerability Assessed by the Investigator	From first drug administration until the end-of-trial examination, up to 28 days.	The investigator assessed tolerability based on adverse events and the laboratory evaluation and classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'. Investigator judgement based on clinical findings: "good" - No or mild adverse events (AEs) and no clinically significant (NCS) findings in any clinical assessments; "satisfactory" - mild or moderate AEs, NCS clinical findings; "not satisfactory" - moderate/severe AEs and/or clinically significant (CS) findings.

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	On day 1, at -2:00 hours (pre-dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.	Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity after first dose.
Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)	At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment.	Maximum measured concentration of the BI 409306 in plasma at steady state over a uniform dosing interval τ after last dose.
Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss)	At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment.	Time from last dosing until the maximum concentration of the analyte in plasma is reached at steady state after last dose on day 14.
Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCτ,ss)	At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment.	This endpoint calculates area under the concentration-time curve of BI 409306 in plasma at steady state over a uniform dosing interval τ after last dose on day 14.
Maximum Concentration of BI 409306 in Plasma (Cmax)	On day 1, at -2:00 hours (pre dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.	Maximum measured concentration of the BI 409306 in plasma after first dose.
Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax)	On day 1, at -2:00 hours (pre-dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose.	Time from dosing to maximum measured concentration of BI 409306 in plasma (Tmax) after the first dose.

Trial Locations

Locations (1)

1289.2.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Mannheim, Germany