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

NCT03804671 | Completed Phase 1 Results

• 2 other identifiers: 1407-00332018-003103-19
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  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.

  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.

Study Arms (1)

All Subjects

EXPERIMENTAL

Test treatment T followed by Reference treatment R

Drug: BI 730357; Drug: BI 730357 mixed with [C-14] BI 730357 BS

Interventions

BI 730357 DRUG

Oral dose

All Subjects

BI 730357 mixed with [C-14] BI 730357 BS DRUG

Intravenous dose

All Subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 65 years (inclusive)
• Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

You may not qualify if:

• Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 45 to 89 mmHg, or pulse rate outside the range of 40 to 100 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Clinically significant gastrointestinal (including known or suspected inflammatory bowel disease), hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

ICON

Groningen, 9728 NZ, Netherlands

Location

Related Publications (1)

• Ooi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1.

  PMID: 36919398 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

Carbon-14

Results Point of Contact

• Title: Boehringer Ingelheim , Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 15, 2019
• Study Start: January 31, 2019
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: July 25, 2023
• Results First Posted: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)