At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 73 enrolled
Drug / intervention
BI 706321 +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.
Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 706321 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
In Brief
A Phase 1 clinical trial evaluating BI 706321 and Placebo for Healthy. Completed, enrolled 73 participants across 1 site.
Detailed Summary
The main objectives are: * Part I: To investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy male subjects following oral administration of single rising doses. * Part II: The relative bioavailability of BI 706321 after administration of tablets and capsules under fasted conditions will be compared with each other and the effect of food on the tablet bioavailability will be investigated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartJun 2019
Primary CompletionDec 2020
TodayJul 2026
First PostedJun 3, 2019
Enrollment StartJun 18, 2019
Primary CompletionDec 4, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.1 years ago
Interventions
BI 706321drug
Capsule or Oral Solution
Placebodrug
Capsule or Oral solution