Clinical Trials

Multiple completed Phase I clinical trials sponsored by Boehringer Ingelheim evaluated BI-409306 exclusively in healthy volunteers to establish its foundational clinical profile. These studies investigated safety, absolute bioavailability, oral disposition of radiolabeled compound, and drug-drug interactions with co-administered rifampicin or oral contraceptives. Overall, the trial landscape reflects early-phase research focused on defining the drug's safety, metabolic disposition, and pharmacokinetic parameters.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03505151 Completed
Healthy
Boehringer Ingelheim
 2018-04-27 Phase 1
NCT03193307 Completed
Healthy
Boehringer Ingelheim
 2017-06-29 Phase 1
NCT03151499 Completed
Healthy
Boehringer Ingelheim
 2017-05-30 Phase 1
NCT02597998 Completed
Healthy
Boehringer Ingelheim
 2015-09-15 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the BI-409306 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BI-409306 selectively binds to and inhibits phosphodiesterase 9A (PDE9A), preventing the breakdown of cyclic guanosine monophosphate (cGMP) and elevating downstream cGMP-mediated intracellular signaling. This sustained cGMP accumulation promotes neuronal synaptic plasticity and long-term potentiation, supporting its Phase 1 clinical evaluation for safety, metabolism, and pharmacokinetics in healthy volunteers.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.