CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 63 enrolled
Drug / intervention
BI 1323495 +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03588390
NCT03588390Phase 1Completed
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 1323495 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)

Boehringer Ingelheim·interventional·Posted Jul 17, 2018·Updated Feb 22, 2024

In Brief

A Phase 1 clinical trial evaluating BI 1323495 and Placebo for Healthy. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJul 17, 2018
Enrollment StartJul 31, 2018
Primary CompletionNov 14, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.0 years ago

Interventions

BI 1323495drug

Low strength tablet

BI 1323495drug

Middle strength tablet

BI 1323495drug

High strength tablet

Placebodrug

Placebo to low strength tablet

Placebodrug

Placebo to middle strength tablet

Placebodrug

Placebo to high strength tablet