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A Study in Healthy Men to Find Out How Well Different Doses of BI 764122 Are Tolerated and Whether Food Affects the Amount of BI 764122 in the Blood

NCT03794323 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-05-01

Study results available
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Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 764122 in healthy male subjects following oral administration of single rising doses.

The objective of the food effect (FE) part is to investigate the relative bioavailability of BI 764122 under fed and fasted conditions.

Conditions

  • Healthy

Interventions

DRUG

BI 764122

Tablet

DRUG

Placebo

Tablet

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2019-08-12
Completion
2019-08-12

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03794323 on ClinicalTrials.gov