Trial Outcomes & Findings for A Study in Healthy Men to Measure the Amount of BI 730357 in the Blood When Taken as a Tablet (NCT NCT03804671)

Last Updated: 2023-07-25

Results Overview

Area under the concentration-time curve of the analyte over the time interval from 0 to infinity (AUC0-∞). For both arms results are presented in millimole (mmol) \* hours (h) / Litre (L) / kilogram (kg). This was achieved by transforming the reference arm to the treatment arm and normalizing the results according to the respective dose.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

6 participants

Primary outcome timeframe

Test treatment T: within 3h before and 1,1.5,2,2.5,3.5,5,7,12,24,72,120,168h after oral administration. Reference treatment R: within 3h before and 5,10,15,30,45 minutes and 1.25,2.25,3.75,5.75,10.75,22.75,70.75,118.75,166.75h after start of iv infusion.

Results posted on

2023-07-25

Participant Flow

The trial was performed as a non-randomised, open-label, single arm, single period trial design in healthy male subjects in order to investigate the absolute oral bioavailability compared to the intravenous administered reference treatment of BI 730357.

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

Participant milestones
Measure	All Subjects 1 tablet with 50 milligram (mg) BI 730357 was administered as a single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as test treatment (T) followed by 100 microgram (μg) of BI 730357 base (BS) (C-14) (2 μg radiolabelled \[C-14\]BI 730357 BS mixed with 98 μg unlabeled BI 730357) administered as 15 minutes (min) intravenous (i.v.) infusion as reference treatment (R) starting 1.25 hours (h) after oral administration.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study in Healthy Men to Measure the Amount of BI 730357 in the Blood When Taken as a Tablet

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=6 Participants 1 tablet with 50 milligram (mg) BI 730357 was administered as a single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as test treatment (T) followed by 100 microgram (μg) of BI 730357 base (BS) (C-14) (2 μg radiolabelled \[C-14\]BI 730357 BS mixed with 98 μg unlabeled BI 730357) administered as 15 minutes (min) intravenous (i.v.) infusion as reference treatment (R) starting 1.25 hours (h) after oral administration.
Age, Continuous	45.2 Years STANDARD_DEVIATION 14.5 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: Test treatment T: within 3h before and 1,1.5,2,2.5,3.5,5,7,12,24,72,120,168h after oral administration. Reference treatment R: within 3h before and 5,10,15,30,45 minutes and 1.25,2.25,3.75,5.75,10.75,22.75,70.75,118.75,166.75h after start of iv infusion.

Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetic (PK) endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Outcome measures

Outcome measures
Measure	BI 730357 50mg Tablet (T) n=6 Participants 1 tablet with 50 milligram (mg) BI 730357 was administered as a single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as test treatment (T).	BI 730357 BS (C-14) 100 µg Infusion (R) n=6 Participants 100 microgram (μg) of BI 730357 BS (C-14) (2 μg radiolabelled \[C-14\]BI 730357 base (BS) mixed with 98 μg unlabelled BI 730357) administered as 15 minutes (min) intravenous (i.v.) infusion as reference treatment (R) starting 1.25 hours (h) after oral administration of test treatment (T).
Area Under the Concentration-time Curve of BI 730357 Over the Time Interval From 0 to Infinity (Dose Normalized).	NA mmol*h/L/kg Standard Error NA Geometric Mean is adjusted Geometric Mean = 160.38 Standard Error is Geometric standard error (gSE) = 1.16	NA mmol*h/L/kg Standard Error NA Geometric Mean is adjusted Geometric Mean = 228.07 Standard Error is Geometric standard error (gSE) = 1.16

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Subjects n=6 participants at risk 1 tablet with 50 milligram (mg) BI 730357 was administered as a single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as test treatment (T) followed by 100 microgram (μg) of BI 730357 base (BS) (C-14) (2 μg radiolabelled \[C-14\]BI 730357 BS mixed with 98 μg unlabeled BI 730357) administered as 15 minutes (min) intravenous (i.v.) infusion as reference treatment (R) starting 1.25 hours (h) after oral administration.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 1/6 • From the first administration of trial drug to the end of residual effect period up to 7 days. Adverse events are reported based on treated set (TS). This subject set included all subjects who were randomized and treated with at least 1 dose of trial drug. The TS was used for safety analyses.
General disorders Catheter site bruise	16.7% 1/6 • From the first administration of trial drug to the end of residual effect period up to 7 days. Adverse events are reported based on treated set (TS). This subject set included all subjects who were randomized and treated with at least 1 dose of trial drug. The TS was used for safety analyses.
Reproductive system and breast disorders Erection increased	16.7% 1/6 • From the first administration of trial drug to the end of residual effect period up to 7 days. Adverse events are reported based on treated set (TS). This subject set included all subjects who were randomized and treated with at least 1 dose of trial drug. The TS was used for safety analyses.

Additional Information

Boehringer Ingelheim , Call Center

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.
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Restriction type: OTHER