Trial Outcomes & Findings for This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 730357 Are Taken up in the Body and How Well They Are Tolerated (NCT NCT03793621)
NCT ID: NCT03793621
Last Updated: 2023-07-12
Results Overview
Number of participants with trial drug-related adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Up to 7 days after drug administration.
Results posted on
2023-07-12
Participant Flow
Investigation of safety and tolerability of BI730357 in healthy subjects following oral administration of single rising doses of 50, 100, and 200mg. The trial was designed as double-blind, randomised within dose group, and placebo-controlled within parallel dose group.
All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered to trial treatment if any of the specific entry criteria were not met.
Participant milestones
| Measure |
Placebo
Placebo film-coated tablet (1 for 50 milligram (mg) group, 1 for 100 mg group, 2 for 200 mg group), administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours. Subjects receiving placebo were equally distributed across dose groups.
|
50 mg BI 730357 Single Dose
1 film-coated tablet (50 milligram) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
100 mg BI 730357 Single Dose
1 film-coated tablet (100 milligram) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
200 mg BI 730357 Single Dose
2 film-coated tablets (100 milligram each) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 730357 Are Taken up in the Body and How Well They Are Tolerated
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Placebo film-coated tablet (1 for 50 milligram (mg) group, 1 for 100 mg group, 2 for 200 mg group), administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours. Subjects receiving placebo were equally distributed across dose groups.
|
50 mg BI 730357 Single Dose
n=6 Participants
1 film-coated tablet (50 milligram) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
100 mg BI 730357 Single Dose
n=6 Participants
1 film-coated tablet (100 milligram) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
200 mg BI 730357 Single Dose
n=6 Participants
2 film-coated tablets (100 milligram each) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.7 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
22.2 Years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
26.8 Years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
32.8 Years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
27.9 Years
STANDARD_DEVIATION 7.2 • n=21 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
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after drug administration.Population: Treated Set (TS): All subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subject received.
Number of participants with trial drug-related adverse events.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo film-coated tablet (1 for 50 milligram (mg) group, 1 for 100 mg group, 2 for 200 mg group), administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours. Subjects receiving placebo were equally distributed across dose groups.
|
50 mg BI 730357 Single Dose
n=6 Participants
1 film-coated tablet (50 milligram) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
100 mg BI 730357 Single Dose
n=6 Participants
1 film-coated tablet (100 milligram) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
200 mg BI 730357 Single Dose
n=6 Participants
2 film-coated tablets (100 milligram each) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Number of Participants With Drug-related Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 3 hours before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 168 hours after drug administration.Population: Pharmacokinetics analysis set (PKS): All subjects in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results are reported.
Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Outcome measures
| Measure |
Placebo
n=5 Participants
Placebo film-coated tablet (1 for 50 milligram (mg) group, 1 for 100 mg group, 2 for 200 mg group), administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours. Subjects receiving placebo were equally distributed across dose groups.
|
50 mg BI 730357 Single Dose
n=6 Participants
1 film-coated tablet (50 milligram) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
100 mg BI 730357 Single Dose
n=4 Participants
1 film-coated tablet (100 milligram) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
200 mg BI 730357 Single Dose
2 film-coated tablets (100 milligram each) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity
|
7160 Hours*Nanomoles per Litre (h*nmol/L)
Geometric Coefficient of Variation 14.3
|
13000 Hours*Nanomoles per Litre (h*nmol/L)
Geometric Coefficient of Variation 48.6
|
13200 Hours*Nanomoles per Litre (h*nmol/L)
Geometric Coefficient of Variation 53.1
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 168 hours after drug administration.Population: Pharmacokinetics analysis set (PKS): All subjects in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 730357 in plasma (Cmax).
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo film-coated tablet (1 for 50 milligram (mg) group, 1 for 100 mg group, 2 for 200 mg group), administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours. Subjects receiving placebo were equally distributed across dose groups.
|
50 mg BI 730357 Single Dose
n=6 Participants
1 film-coated tablet (50 milligram) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
100 mg BI 730357 Single Dose
n=6 Participants
1 film-coated tablet (100 milligram) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
200 mg BI 730357 Single Dose
2 film-coated tablets (100 milligram each) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Maximum Measured Concentration of BI 730357 in Plasma
|
346 Nanomoles per Litre (nmol/L)
Geometric Coefficient of Variation 23.0
|
451 Nanomoles per Litre (nmol/L)
Geometric Coefficient of Variation 34.8
|
515 Nanomoles per Litre (nmol/L)
Geometric Coefficient of Variation 48.2
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
50 mg BI 730357 Single Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
100 mg BI 730357 Single Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
200 mg BI 730357 Single Dose
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Total
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=6 participants at risk
Placebo film-coated tablet (1 for 50 milligram (mg) group, 1 for 100 mg group, 2 for 200 mg group), administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours. Subjects receiving placebo were equally distributed across dose groups.
|
50 mg BI 730357 Single Dose
n=6 participants at risk
1 film-coated tablet (50 milligram) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
100 mg BI 730357 Single Dose
n=6 participants at risk
1 film-coated tablet (100 milligram) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
200 mg BI 730357 Single Dose
n=6 participants at risk
2 film-coated tablets (100 milligram each) of BI 730357, administered as single oral dose with \~240 milliliter of water after an overnight fast of at least 10 hours.
|
Total
n=24 participants at risk
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/6 • [Serious and Other Adverse Events]: Up to 7 days after drug administration. [All-cause mortality]: From drug administration until end of trial, up to 13 days.
Adverse events are reported based on treated set (TS). This set included all subjects who were randomized and treated with at least 1 dose of trial drug. The TS was used for safety analyses.
|
0.00%
0/6 • [Serious and Other Adverse Events]: Up to 7 days after drug administration. [All-cause mortality]: From drug administration until end of trial, up to 13 days.
Adverse events are reported based on treated set (TS). This set included all subjects who were randomized and treated with at least 1 dose of trial drug. The TS was used for safety analyses.
|
0.00%
0/6 • [Serious and Other Adverse Events]: Up to 7 days after drug administration. [All-cause mortality]: From drug administration until end of trial, up to 13 days.
Adverse events are reported based on treated set (TS). This set included all subjects who were randomized and treated with at least 1 dose of trial drug. The TS was used for safety analyses.
|
16.7%
1/6 • [Serious and Other Adverse Events]: Up to 7 days after drug administration. [All-cause mortality]: From drug administration until end of trial, up to 13 days.
Adverse events are reported based on treated set (TS). This set included all subjects who were randomized and treated with at least 1 dose of trial drug. The TS was used for safety analyses.
|
4.2%
1/24 • [Serious and Other Adverse Events]: Up to 7 days after drug administration. [All-cause mortality]: From drug administration until end of trial, up to 13 days.
Adverse events are reported based on treated set (TS). This set included all subjects who were randomized and treated with at least 1 dose of trial drug. The TS was used for safety analyses.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
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