NCT03804671

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

Completed Phase 1 Results posted Last updated 25 July 2023

What this trial tests

Phase 1 trial testing BI 730357 in Healthy in 6 participants. Completed in 26 March 2019.

Timeline

31 January 2019

Primary endpoint
26 March 2019

26 March 2019

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	31 January 2019
Primary completion	26 March 2019
Estimated completion	26 March 2019
Sites	1 location across Netherlands

Drugs / interventions tested

• BI 730357 — full drug profile →
• BI 730357 mixed with [C-14] BI 730357 BS — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 65, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under the Concentration-time Curve of BI 730357 Over the Time Interval From 0 to Infinity (Dose Normalized). Primary · 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.

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.

Group	Value	95% CI
BI 730357 50mg Tablet (T)	NA	± NA
BI 730357 BS (C-14) 100 µg Infusion (R)	NA	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first administration of trial drug to the end of residual effect period up to 7 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Subjects

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (3 terms — click to expand)

Reaction	System	All Subjects
Catheter site bruise	General disorders	—
Erection increased	Reproductive system and breast disorders	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT03804671 adverse events section.

Sponsor's own description

To investigate the absolute oral bioavailability of BI 730357 administered as tablet compared with \[C-14\]BI 730357 BS administered as intravenous microtracer

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357.
   Ooi QX, Kristoffersson A, Korell J, Flack M, et al · · 2023 · cited 7× · PMID 36919398 · DOI 10.1002/psp4.12948
2. Assessing Drug-Drug Interaction and Food Effect for BCS Class 2 Compound BI 730357 (Retinoic Acid-Related Orphan Receptor Gamma Antagonist, Bevurogant) Using a Physiology-Based Pharmacokinetics Modeling (PBPK) Approach with Semi-Mechanistic Absorption.
   Kanacher T, Sjögren E, Korell J, Plan EL, et al · · 2025 · PMID 40142978 · DOI 10.3390/pharmaceutics17030314