Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809
Phase 1
Completed
NCT02068690
| Condition | Healthy |
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| Phase | Phase 1 |
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| Sponsor | Boehringer Ingelheim |
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| Status | Completed |
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| Enrollment | 83 participants |
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| Interventions | BI 425809 PfOS, Placebo PfOS, BI 425809 tablet |
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| Start date | Mar 20, 2014 |
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| Completion date | Sep 10, 2014 |
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| Results posted | May 5, 2026 |
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Summary
To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809 tablet fasted and tablet fed
Number of Participants With Drug-related Adverse Events (AE)
SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention. · Participants
| SRD Part: Placebo | 3 Participants |
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| SRD Part: 0.5 mg BI 425809 | 1 Participants |
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| SRD Part: 1 mg BI 425809 | 2 Participants |
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| SRD Part: 2 mg BI 425809 | 1 Participants |
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| SRD Part: 5 mg BI 425809 | 2 Participants |
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| SRD Part: 10 mg BI425809 | 1 Participants |
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Open in BENITIONS
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