Trial Outcomes & Findings for Evaluation of Safety and Tolerability of Single Rising Doses of BI 473494 in Healthy Subjects (NCT NCT03195088)
NCT ID: NCT03195088
Last Updated: 2022-07-14
Results Overview
Percentage of participants with drug-related adverse events (AEs) analysed as investigator defined drug-related AEs is presented. Medical judgment was used to determine the relationship between the AEs and the study medication, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
TERMINATED
PHASE1
16 participants
From drug administration until End of trial (EOT), up to 40 days.
2022-07-14
Participant Flow
It was planned to include healthy participants in this single-rising dose trial with a single-blind, partially randomised, placebo controlled and parallel group design. They were recruited from the volunteer's pool of the study site.
All participants were screened for eligibility to participate in the trial by the trial site. The site ensured that the participants met all strictly implemented inclusion/exclusion criteria. Participants were not to be assigned to treatment groups if any one of the specific entry criteria were violated.
Participant milestones
| Measure |
Placebo Matching BI 473494
Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.
|
BI 473494 35 μg
Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.
|
BI 473494 75 μg
Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Safety and Tolerability of Single Rising Doses of BI 473494 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Placebo Matching BI 473494
n=4 Participants
Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.
|
BI 473494 35 μg
n=6 Participants
Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.
|
BI 473494 75 μg
n=6 Participants
Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
34.3 Years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
34.0 Years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
30.2 Years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
32.6 Years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From drug administration until End of trial (EOT), up to 40 days.Population: Treated set (TS) : The TS included all subjects who were dispensed study medication and were documented to have taken at least one dose of BI 473494.
Percentage of participants with drug-related adverse events (AEs) analysed as investigator defined drug-related AEs is presented. Medical judgment was used to determine the relationship between the AEs and the study medication, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
Outcome measures
| Measure |
Placebo Matching BI 473494
n=4 Participants
Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.
|
BI 473494 35 μg
n=6 Participants
Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.
|
BI 473494 75 μg
n=6 Participants
Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.
|
|---|---|---|---|
|
Percentage of Participants With Drug-related Adverse Events (AEs) Analysed as Investigator Defined Drug-related AEs
|
0.0 Percentage of participants (%)
|
0.0 Percentage of participants (%)
|
16.7 Percentage of participants (%)
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were taken 1:00 hour:minute (h:m) pre-dose and 3:00, 6:00, 9:00, 12:00, 15:00 , 22:00, 24:00, 28:00, 34:00, 39:00, 48:00, 60:00, 72:00, 96:00, 120:00, 168:00, 240:00, 336:00, 504:00 and 672:00 h:m after drug administration on day 1Population: Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects from the TS who received study medication and provided at least one secondary PK parameter that was not excluded due to important protocol deviations with respect to the statistical evaluation of PK endpoints.
AUC0-tz, area under the concentration-time curve of BI 473494 over the time interval from 0 to the last quantifiable time point is presented.
Outcome measures
| Measure |
Placebo Matching BI 473494
n=6 Participants
Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.
|
BI 473494 35 μg
n=6 Participants
Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.
|
BI 473494 75 μg
Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 473494 Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz)
|
162 Nanomole*Hours/Litre (nmol*h/L)
Geometric Coefficient of Variation 24.8
|
546 Nanomole*Hours/Litre (nmol*h/L)
Geometric Coefficient of Variation 18.5
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were taken 1:00 hour:minute (h:m) pre-dose and 3:00, 6:00, 9:00, 12:00, 15:00 , 22:00, 24:00, 28:00, 34:00, 39:00, 48:00, 60:00, 72:00, 96:00, 120:00, 168:00, 240:00, 336:00, 504:00 and 672:00 h:m after drug administration on day 1Population: Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects from the TS who received study medication and provided at least one secondary PK parameter that was not excluded due to important protocol deviations with respect to the statistical evaluation of PK endpoints.
Cmax, maximum measured concentration of BI 473494 is presented.
Outcome measures
| Measure |
Placebo Matching BI 473494
n=6 Participants
Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.
|
BI 473494 35 μg
n=6 Participants
Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.
|
BI 473494 75 μg
Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.
|
|---|---|---|---|
|
Maximum Measured Concentration of BI 473494 (Cmax)
|
0.82 Nanomole/Litre (nmol/L)
Geometric Coefficient of Variation 23.1
|
1.88 Nanomole/Litre (nmol/L)
Geometric Coefficient of Variation 17.5
|
—
|
Adverse Events
Placebo Matching BI 473494
BI 473494 35 μg
BI 473494 75 μg
Serious adverse events
| Measure |
Placebo Matching BI 473494
n=4 participants at risk
Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.
|
BI 473494 35 μg
n=6 participants at risk
Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.
|
BI 473494 75 μg
n=6 participants at risk
Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.
|
|---|---|---|---|
|
Nervous system disorders
Acute polyneuropathy
|
0.00%
0/4 • From drug administration until End of trial (EOT), up to 40 days.
|
0.00%
0/6 • From drug administration until End of trial (EOT), up to 40 days.
|
16.7%
1/6 • From drug administration until End of trial (EOT), up to 40 days.
|
Other adverse events
| Measure |
Placebo Matching BI 473494
n=4 participants at risk
Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.
|
BI 473494 35 μg
n=6 participants at risk
Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.
|
BI 473494 75 μg
n=6 participants at risk
Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From drug administration until End of trial (EOT), up to 40 days.
|
33.3%
2/6 • From drug administration until End of trial (EOT), up to 40 days.
|
0.00%
0/6 • From drug administration until End of trial (EOT), up to 40 days.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/4 • From drug administration until End of trial (EOT), up to 40 days.
|
0.00%
0/6 • From drug administration until End of trial (EOT), up to 40 days.
|
16.7%
1/6 • From drug administration until End of trial (EOT), up to 40 days.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • From drug administration until End of trial (EOT), up to 40 days.
|
0.00%
0/6 • From drug administration until End of trial (EOT), up to 40 days.
|
16.7%
1/6 • From drug administration until End of trial (EOT), up to 40 days.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • From drug administration until End of trial (EOT), up to 40 days.
|
0.00%
0/6 • From drug administration until End of trial (EOT), up to 40 days.
|
16.7%
1/6 • From drug administration until End of trial (EOT), up to 40 days.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/4 • From drug administration until End of trial (EOT), up to 40 days.
|
0.00%
0/6 • From drug administration until End of trial (EOT), up to 40 days.
|
16.7%
1/6 • From drug administration until End of trial (EOT), up to 40 days.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/4 • From drug administration until End of trial (EOT), up to 40 days.
|
0.00%
0/6 • From drug administration until End of trial (EOT), up to 40 days.
|
16.7%
1/6 • From drug administration until End of trial (EOT), up to 40 days.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER