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A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood
Sponsor: Boehringer Ingelheim
Summary
The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202. The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation.
Official title: A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3000202 Administered as Tablet to Healthy Male Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 3000202 as Tablet With and Without Food in Healthy Male Subjects
Key Details
Gender
MALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2023-07-25
Completion Date
2023-11-13
Last Updated
2026-06-08
Healthy Volunteers
Yes
Conditions
Interventions
BI 3000202
BI 3000202
Placebo matching BI 3000202
Placebo matching BI 3000202
Locations (1)
Humanpharmakologisches Zentrum Biberach
Biberach, Germany