Phase 1
N=83
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01505894 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group — 6; 3; 5; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 409306 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group |
6; 3; 5; 6; 4; 8 | — |
| PRIMARY Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Per Category of Global Tolerability Assessed by the Investigator |
11; 9; 9; 9; 9; 9 | — |
| PRIMARY Number of Participants With Abnormal Findings in Color Discrimination Test |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With Abnormal Findings in Visual Acuity Test |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Concentration of BI 409306 in Plasma (Cmax) |
245; 376; 565; 696; 1100; 1030 | — |
| SECONDARY Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax) |
0.750; 0.500; 0.500; 0.750; 0.333; 0.500 | — |
| SECONDARY Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
548; 594; 955; 1140; 1510; 1620 | — |
| SECONDARY Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) |
348; 444; 663; 596; 1250; 1260 | — |
| SECONDARY Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss) |
0.750; 0.500; 0.625; 0.750; 0.417; 0.500 | — |
| SECONDARY Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCτ,ss) |
747; 621; 1070; 1100; 1710; 1960 | — |
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
Eligibility Criteria
Inclusion criteria
- Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- Age >21 and Age 65 and Age 18.5 and BMI 20 mm Hg and increase in heart rate > 30 bpm after 2 minutes standing relative to supine data), fainting spells or blackouts.
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of any drugs within 14 days or drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within four weeks prior to administration or during the trial
- Smoker (> 5 cigarettes or > 1 cigars or > 1 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 20 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance in the judgment of investigator
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc F interval >430 ms in males and >450 ms in females);
- A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);
Data sourced from ClinicalTrials.gov (NCT01505894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.