Trial Outcomes & Findings for A Study in Healthy Japanese Men to Test How Different Doses of BI 894416 Are Tolerated (NCT NCT04540874)
NCT ID: NCT04540874
Last Updated: 2023-08-16
Results Overview
The percentage of participants with drug related adverse events was reported.
TERMINATED
PHASE1
8 participants
From drug administration until end of follow-up, up to 17 days.
2023-08-16
Participant Flow
This single-blind, randomised, placebo-controlled within dose group study investigated the safety, tolerability, and pharmacokinetics of single rising oral doses of BI 894416 versus placebo in healthy male Japanese subjects followed by 48 hours close medical surveillance and 2 weeks of follow-up period thereafter. This trial was prematurely terminated due to decision of sponsor.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
BI 894416 25mg
1 tablet of 25 milligrams (mg) BI 894416 was administered orally as single dose with 240 milliliters of water after an overnight fast of at least 10 hours on day 1, followed by at least 48 hours close medical surveillance, followed by 2 weeks of follow-up period.
|
Placebo
Matching placebo was administered orally as single dose with 240 milliliters of water after an overnight fast of at least 10 hours on day 1, followed by at least 48 hours close medical surveillance, followed by 2 weeks of follow-up period.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
|
Overall Study
COMPLETED
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Japanese Men to Test How Different Doses of BI 894416 Are Tolerated
Baseline characteristics by cohort
| Measure |
BI 894416 25mg
n=6 Participants
1 tablet of 25 milligrams (mg) BI 894416 was administered orally as single dose with 240 milliliters of water after an overnight fast of at least 10 hours on day 1, followed by at least 48 hours close medical surveillance, followed by 2 weeks of follow-up period.
|
Placebo
n=2 Participants
Matching placebo was administered orally as single dose with 240 milliliters of water after an overnight fast of at least 10 hours on day 1, followed by at least 48 hours close medical surveillance, followed by 2 weeks of follow-up period.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.5 Years
STANDARD_DEVIATION 7.7 • n=99 Participants
|
31.5 Years
STANDARD_DEVIATION 12.0 • n=107 Participants
|
31.5 Years
STANDARD_DEVIATION 8.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From drug administration until end of follow-up, up to 17 days.Population: Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of investigational medicinal product. The treatment assignment will be determined based on the first treatment the subjects received.
The percentage of participants with drug related adverse events was reported.
Outcome measures
| Measure |
BI 894416 25mg
n=6 Participants
1 tablet of 25 milligrams (mg) BI 894416 was administered orally as single dose with 240 milliliters of water after an overnight fast of at least 10 hours on day 1, followed by at least 48 hours close medical surveillance, followed by 2 weeks of follow-up period.
|
Placebo
n=2 Participants
Matching placebo was administered orally as single dose with 240 milliliters of water after an overnight fast of at least 10 hours on day 1, followed by at least 48 hours close medical surveillance, followed by 2 weeks of follow-up period.
|
|---|---|---|
|
Percentage of Participants With Drug Related Adverse Events
|
16.7 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Within 1 hour (h) before drug administration and at 15 minutes (min), 30min, 45min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the treated set who provide at least one PK endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject will be included in the PKS, even if he contributes only one PK parameter value for one period to the statistical assessment.
Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity was reported.
Outcome measures
| Measure |
BI 894416 25mg
n=6 Participants
1 tablet of 25 milligrams (mg) BI 894416 was administered orally as single dose with 240 milliliters of water after an overnight fast of at least 10 hours on day 1, followed by at least 48 hours close medical surveillance, followed by 2 weeks of follow-up period.
|
Placebo
Matching placebo was administered orally as single dose with 240 milliliters of water after an overnight fast of at least 10 hours on day 1, followed by at least 48 hours close medical surveillance, followed by 2 weeks of follow-up period.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
3550 hour * nanomole / liter
Geometric Coefficient of Variation 26.6
|
—
|
SECONDARY outcome
Timeframe: Within 1 hour (h) before drug administration and at 15 minutes (min), 30min, 45min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the treated set who provide at least one PK endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject will be included in the PKS, even if he contributes only one PK parameter value for one period to the statistical assessment.
Maximum measured concentration of BI 894416 in plasma was reported.
Outcome measures
| Measure |
BI 894416 25mg
n=6 Participants
1 tablet of 25 milligrams (mg) BI 894416 was administered orally as single dose with 240 milliliters of water after an overnight fast of at least 10 hours on day 1, followed by at least 48 hours close medical surveillance, followed by 2 weeks of follow-up period.
|
Placebo
Matching placebo was administered orally as single dose with 240 milliliters of water after an overnight fast of at least 10 hours on day 1, followed by at least 48 hours close medical surveillance, followed by 2 weeks of follow-up period.
|
|---|---|---|
|
Maximum Measured Concentration of BI 894416 in Plasma (Cmax)
|
708 nanomole / liter
Geometric Coefficient of Variation 25.0
|
—
|
Adverse Events
BI 894416 25mg
Placebo
Total
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 894416 25mg
n=6 participants at risk
1 tablet of 25 milligrams (mg) BI 894416 was administered orally as single dose with 240 milliliters of water after an overnight fast of at least 10 hours on day 1, followed by at least 48 hours close medical surveillance, followed by 2 weeks of follow-up period.
|
Placebo
n=2 participants at risk
Matching placebo was administered orally as single dose with 240 milliliters of water after an overnight fast of at least 10 hours on day 1, followed by at least 48 hours close medical surveillance, followed by 2 weeks of follow-up period.
|
Total
n=8 participants at risk
All treated participants in this study.
|
|---|---|---|---|
|
General disorders
Feeling abnormal
|
16.7%
1/6 • From drug administration until end of follow-up, up to 17 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of investigational medicinal product. The treatment assignment will be determined based on the first treatment the subjects received.
|
0.00%
0/2 • From drug administration until end of follow-up, up to 17 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of investigational medicinal product. The treatment assignment will be determined based on the first treatment the subjects received.
|
12.5%
1/8 • From drug administration until end of follow-up, up to 17 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of investigational medicinal product. The treatment assignment will be determined based on the first treatment the subjects received.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/6 • From drug administration until end of follow-up, up to 17 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of investigational medicinal product. The treatment assignment will be determined based on the first treatment the subjects received.
|
50.0%
1/2 • From drug administration until end of follow-up, up to 17 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of investigational medicinal product. The treatment assignment will be determined based on the first treatment the subjects received.
|
12.5%
1/8 • From drug administration until end of follow-up, up to 17 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of investigational medicinal product. The treatment assignment will be determined based on the first treatment the subjects received.
|
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