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Clinical Trials/NCT01505894
NCT01505894CompletedPhase 1

Safety, Tolerability Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 409306 Film-coated Tablets Given Orally q.d. or Bid for 14 Days in Young Healthy and Elderly Healthy Male/Female Volunteers (Randomised, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)

Boehringer Ingelheim1 site in 1 country83 target enrollmentStarted: January 1, 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
83
Locations
1
Primary Endpoint
Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
21 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Placebo - Young Subjects

Placebo Comparator

Placebo - Young Subjects

Intervention: Placebo (Drug)

Placebo - Elderly Subjects

Placebo Comparator

Placebo - Elderly Subjects

Intervention: Placebo (Drug)

BI 409306 25 mg - Young Subjects QD

Experimental

25 milligram (mg) of BI 409306 were administered in young subjects once daily (QD).

Intervention: BI 409306 (Drug)

BI 409306 25 mg - Elderly Subjects QD

Experimental

25 mg of BI 409306 were administered in elderly subjects once daily (QD).

Intervention: BI 409306 (Drug)

BI 409306 50 mg - Young Subjects QD

Experimental

50 mg of BI 409306 were administered in young subjects once daily (QD).

Intervention: BI 409306 (Drug)

BI 409306 50 mg - Young Subjects BID

Experimental

50 mg of BI 409306 were administered in young subjects twice daily (BID).

Intervention: BI 409306 (Drug)

BI 409306 50 mg - Elderly Subjects QD

Experimental

50 mg of BI 409306 were administered in elderly subjects once daily

Intervention: BI 409306 (Drug)

BI 409306 100 mg - Young Subjects QD

Experimental

100 mg of BI 409306 were administered in young subjects once daily (QD).

Intervention: BI 409306 (Drug)

BI 409306 100 mg - Elderly Subjects QD

Experimental

100 mg of BI 409306 were administered in elderly subjects once daily (QD).

Intervention: BI 409306 (Drug)

Outcomes

Primary Outcomes

Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • 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.)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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