NCT03483077

This Study in Healthy Volunteers Determines the Amount of BI 730460 in the Blood When Taken as Tablet. It Looks at How Different Doses of BI 730460 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How Food Influences the Amount of BI 730460 in the Blood.

A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 730460 Administered as Tablets to Healthy Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Bioavailability Comparison of BI 730460 as Tablet With and Without Food

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the single-rising dose (SRD) part (trial part 1) is to investigate the safety and tolerability of BI 730460 in healthy subjects following oral administration of single rising doses. The secondary objective is the exploration of the pharmacokinetics (PK) including dose proportionality, and pharmacodynamics of BI 730460 after single dosing.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 730460	tablets
DRUG	Placebo	tablets

Timeline

• Start date: 2018-10-09
• Primary completion: 2019-03-21
• Completion: 2019-03-21
• First posted: 2018-03-29
• Last updated: 2022-08-10
• Results posted: 2022-08-10

Locations

1 site across 1 country: Germany