Boehringer Ingelheim Registers New Phase I Clinical Trial (NCT07693218) to Evaluate Pharmacokinetics of Investigational Drug BI 1815368 in Healthy Men

August 2, 2026

ClinicalTrials.gov USA

Overview

Boehringer Ingelheim has registered a new Phase I clinical trial (NCT07693218) on ClinicalTrials.gov to evaluate the pharmacokinetics of investigational drug BI 1815368 in healthy men. The study targets healthy male participants aged 18 to 55 years with a BMI of 18.5 to 29.9 kg/m2. The record was first posted on July 9, 2026, and last updated on July 23, 2026.

In Depth

Key Findings

Boehringer Ingelheim has registered a new Phase I clinical trial (NCT07693218) on ClinicalTrials.gov to assess how the investigational drug BI 1815368 is processed in the human body among healthy male participants. This study aims to characterize the pharmacokinetic profile (absorption, distribution, metabolism, and excretion) of the drug.

Technical / Clinical Details

The trial targets healthy male participants aged 18 to 55 years with a Body Mass Index (BMI) ranging from 18.5 to 29.9 kg/m2. The primary objectives of a Phase I study are to evaluate the safety and tolerability of the investigational drug, as well as to thoroughly analyze its behavior within the body, including concentration profiles and excretion pathways. Typically, this stage involves pharmacokinetic assessments of both single and multiple doses, with the results providing crucial information for future dose selection and the design of larger clinical trials involving patient populations. The specific mechanism of action or target disease for BI 1815368 is not disclosed in this registration information.

Background & Context

A clear understanding of drug pharmacokinetics during the early stages of clinical development is paramount for new drug candidates. Accurate pharmacokinetic data is essential for determining effective therapeutic doses, predicting potential side effects, and assessing the risk of drug-drug interactions. Registering clinical trials on public registries like ClinicalTrials.gov is internationally recommended to enhance transparency, prevent research duplication, and adhere to ethical standards in medical research.

Strategic Significance & Outlook

The results from this Phase I study will provide foundational information for the further clinical development of BI 1815368. If a favorable safety profile and predictable pharmacokinetics are confirmed, the drug could progress to Phase II trials, targeting specific patient populations. Success at this early stage represents a significant milestone in the pharmaceutical development pipeline and holds the potential to expand future treatment options.

Source: https://clinicaltrials.gov/study/NCT07693218

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