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This Study in Healthy Men Tests How Different Doses of BI 1323495 Are Taken up in the Body and How Well They Are Tolerated.

NCT03588390 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-02-22

Study results available
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Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 1323495 in healthy male subjects following oral administration of single rising doses.

Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality and pharmacodynamics (PD) of BI 1323495 after single dosing and the assessment of the PK/PD relationship.

Conditions

  • Healthy

Interventions

DRUG

BI 1323495

Low strength tablet

DRUG

BI 1323495

Middle strength tablet

DRUG

BI 1323495

High strength tablet

DRUG

Placebo

Placebo to low strength tablet

DRUG

Placebo

Placebo to middle strength tablet

DRUG

Placebo

Placebo to high strength tablet

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2018-11-14
Completion
2018-11-14

Countries

  • Germany

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 NCT03588390 on ClinicalTrials.gov