NCT03617835

A Study in Healthy People to Measure the Amount of BI 655130 in the Blood After Injecting Different Doses Into Different Parts of the Body

Relative Bioavailability, Safety, and Tolerability Following Subcutaneous Injection of Different Doses of BI 655130 and Different Injection Sites in Healthy Male and Female Subjects (a Single Dose, Mono-centric, Open-label Study in Matched-group Design).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this trial is to investigate the relative bioavailability of BI 655130 administered as two subcutaneous injections in the left and right periumbilical region compared to a single subcutaneous periumbilical injection of BI 655130. The secondary objective is to investigate the relative bioavailability of a single subcutaneous injection of BI 655130 into the thigh compared to a single subcutaneous periumbilical injection of BI 655130.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	R - Low dose of BI 655130	Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.
DRUG	T1 - Low dose of BI 655130	Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.
DRUG	T2 - Low dose of BI 655130	Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.
DRUG	T3 - High dose of BI 655130	Single high dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 2 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.

Timeline

• Start date: 2018-08-16
• Primary completion: 2019-06-03
• Completion: 2019-06-03
• First posted: 2018-08-06
• Last updated: 2025-10-20
• Results posted: 2024-03-15

Locations

1 site across 1 country: Belgium