A Phase 1 interventional study of BI 730357 mixed with [C-14]BI 730357 BS in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
The main objectives of the study are as follows:
Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
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Subjects who are sexually active must use, with their partner, highly effective contraception from the time of administration of trial medication until 4 months after administration of trial medication. Adequate methods are:
Exclusion Criteria:
All participants were administered an oral single dose of 50 milligram (mg) BI 730357 containing \[C-14\] BI 730357 base (BS) (pure 14C-labelled "hot" drug substance) and BI 730357 BS (unlabelled "cold" drug substance). This mixture corresponds to the warm substance BI 730357 BS (C-14) containing a radioactive dose of approximately 3.7 MegaBecquerel (MBq), (100 microcurie (µCi)), and was administered in a solution of 10 milliliter (mL) volume with 240 mL of water after an overnight fast of at least 10 hours (h).
Drug: BI 730357 mixed with [C-14]BI 730357 BS
Oral Solution
Mass Balance Recovery of Total [14C]-Radioactivity in Urine (Feurine, 0-tz)
feurine, fractions of \[14C\]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to tz, where tz is the latest quantifiable data point across all participants.
Time frame: Within 18 hours (h) predose, 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336 h after dosing on Day 1, continued in 24 h intervals, every 7 days from Day 21 until Day 50.
Mass Balance Recovery of Total [14C]-Radioactivity in Faeces (Fefaeces, 0-tz)
fefaeces, 0-tz, fraction of \[14C\]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to tz, where tz is the latest quantifiable data point across all participants.
Time frame: Within 48 hours (h) predose, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312 and 312-336 h after dosing on Day 1 and continued in 24 h intervals, every 7 days up to Day 50.
Maximum Measured Concentration of 14C-BI 730357-equivalent (EQ) and BI 730357 (Cmax)
Cmax, maximum measured concentration of 14C-BI 730357-equivalent (EQ) and BI 730357 in plasma after a single oral dose of 50 mg BI 730357 BS (C-14) is presented. Plasma concentrations of (C-14) BI 730357-radioactivity are expressed as 14C-BI 730357-EQ.
Time frame: Within 3:00 Hours: minutes (h:m) pre-dose, 0:30, 1:00, 1:30, 2:00, 4:00, 8:00, 12:00, 24:00, 48:00, 72:00, 120:00, 168:00, 216:00, 264:00, 312:00, 485:00, 653:00 and 821:00 after drug administration.
Area Under the Concentration-time Curve of 14C-BI 730357-equivalent (EQ) and BI 730357 Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz)
AUC0-tz, area under the concentration-time curve of 14C-BI 730357-equivalent (EQ) and BI 730357 over the time interval from 0 to the last quantifiable time point in plasma after a single oral dose of 50 mg BI 730357 BS (C-14) is presented. Plasma concentrations of (C-14) BI 730357-radioactivity are expressed as 14C-BI 730357-EQ.
Time frame: Within 3:00 Hours: minutes (h:m) pre-dose, 0:30, 1:00, 1:30, 2:00, 4:00, 8:00, 12:00, 24:00, 48:00, 72:00, 120:00, 168:00, 216:00, 264:00, 312:00, 485:00, 653:00 and 821:00 after drug administration.
It was planned to include healthy male participants in this non-randomised, open-label, single-arm, single-dose trial. They were recruited from the volunteer's pool of the study site.
| Milestone | BI 730357 |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
feurine, fractions of \[14C\]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to tz, where tz is the latest quantifiable data point across all participants.
| Percentage of administered dose (%) | BI 730357 |
|---|---|
| Mass Balance Recovery of Total [14C]-Radioactivity in Urine (Feurine, 0-tz) | 34.3 ± 19.2 |
fefaeces, 0-tz, fraction of \[14C\]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to tz, where tz is the latest quantifiable data point across all participants.
| Percentage of administered dose (%) | BI 730357 |
|---|---|
| Mass Balance Recovery of Total [14C]-Radioactivity in Faeces (Fefaeces, 0-tz) | 65.0 ± 8.09 |
Cmax, maximum measured concentration of 14C-BI 730357-equivalent (EQ) and BI 730357 in plasma after a single oral dose of 50 mg BI 730357 BS (C-14) is presented. Plasma concentrations of (C-14) BI 730357-radioactivity are expressed as 14C-BI 730357-EQ.
| Nanomole/litre (nmol/L) | 14C-BI 730357-EQ and BI 730357 |
|---|---|
| 14C-BI 730357-EQ | 1020 ± 16.5 |
| BI 730357 | 641 ± 19.2 |
AUC0-tz, area under the concentration-time curve of 14C-BI 730357-equivalent (EQ) and BI 730357 over the time interval from 0 to the last quantifiable time point in plasma after a single oral dose of 50 mg BI 730357 BS (C-14) is presented. Plasma concentrations of (C-14) BI 730357-radioactivity are expressed as 14C-BI 730357-EQ.
| Nanomole*Hours/litre (nmol*h/L) | 14C-BI 730357-EQ and BI 730357 |
|---|---|
| 14C-BI 730357-EQ | 24300 ± 50.8 |
| BI 730357 | 9410 ± 79.9 |
Collected over From drug administration until End-of-trial (EoT) examination, up to 50 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BI 730357 | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Event | BI 730357 |
|---|---|
| HeadacheNervous system disorders | 2/6 |
| Catheter site haematomaGeneral disorders | 1/6 |
| Catheter site inflammationGeneral disorders | 1/6 |
| Vessel puncture site haematomaGeneral disorders | 1/6 |
| ParaesthesiaNervous system disorders | 1/6 |
| Back painMusculoskeletal and connective tissue disorders | 1/6 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/6 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/6 |
| PruritusSkin and subcutaneous tissue disorders | 1/6 |
Treated set (TS) :This subject set included all participants who were documented to have received one dose of trial medication.
| Age, Continuous(Years) | BI 730357 |
|---|---|
| Mean | 44.2 ± 16.6 |
| Sex: Female, Male(Participants) | BI 730357 |
|---|---|
| Female | 0 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | BI 730357 |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | BI 730357 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 5 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency
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