CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
Placebo +1 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/NCT04964453
NCT04964453Phase 1Completed
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Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 474121 in Healthy Japanese Male Subjects (Doubleblind, Randomised, Placebo-controlled, Parallel Group Design)

Boehringer Ingelheim·interventional·Posted Jul 16, 2021·Updated Mar 7, 2024

In Brief

A Phase 1 clinical trial evaluating Placebo and BI 474121 for Healthy. Completed, enrolled 32 participants across 1 site.

Detailed Summary

Safety, tolerability, and pharmacokinetics of BI 474121 will be assessed in healthy Japanese male using single rising oral doses in order to provide the basis for an ongoing clinical development of BI 474121 for the treatment of cognitive impairment in patients with Alzheimer's Disease and schizophrenia.

Study Details

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

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedJul 16, 2021
Enrollment StartJul 21, 2021
Primary CompletionNov 11, 2021
Study CompletionNov 16, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.0 years ago

Interventions

Placebodrug

Healthy subjects were given a single dose of placebo tablet(s) matched to the active treatment, subjects receiving placebo were equally distributed across dose groups. Tablet(s) were taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.

BI 474121drug

Healthy subjects were given a single dose of BI 474121 as a uncoated tablet(s) taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.