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TERMINATED
NCT06716190
PHASE1

A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics and pharmacodynamics of BI 3731579 in healthy volunteers following administration of multiple rising doses per day over 15 days.

Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 3731579 in Healthy Volunteers (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-12-18

Completion Date

2025-06-23

Last Updated

2026-08-10

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Mid-dose bid BI 3731579

Day 2 and Day 17: a single mid dose of BI 3731579, with 240 mL of water. Day 4 to Day 16: a double daily mid dose (bid) of BI 3731579 each day, with 240 mL of water.

DRUG

Placebo-matching BI 3731579

Placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water.

DRUG

Midazolam

Day 1 and Day 17: 75 micrograms (μg) of Midazolam for injection, orally, with 240 mL of water, as a single dose.

DRUG

Low-dose bid BI 3731579

Day 2 and Day 17: single low dose of BI 3731579 with 240 milliliters (mL) of water. Day 4 to Day 16: a double daily low dose (bid) of BI 3731579 each day, with 240 mL of water.

DRUG

High-dose bid BI 3731579

Day 2 and Day 17: single high dose of BI 3731579, with 240 mL of water. Day 4 to Day 16: a double daily high dose (bid) of BI 3731579 each day, with 240 mL of water.

Locations (1)

SGS Life Science Services - Clinical Research

Edegem, Belgium