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- || BI 1569912 / Boehringer Ingelheim
Enrollment open: A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood (clinicaltrials.gov) - May 20, 2024
P1, N=18, Recruiting, Sponsor: Boehringer Ingelheim
Not yet recruiting --> Recruiting
- || BI 1569912 / Boehringer Ingelheim
New P1 trial: A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood (clinicaltrials.gov) - Apr 16, 2024
P1, N=18, Not yet recruiting, Sponsor: Boehringer Ingelheim
- |||| BI 1569912 / Boehringer Ingelheim
Enrollment open: A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine (clinicaltrials.gov) - Apr 3, 2024
P2, N=204, Recruiting, Sponsor: Boehringer Ingelheim
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| BI 1569912 / Boehringer Ingelheim
New P2 trial: A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine (clinicaltrials.gov) - Feb 28, 2024
P2, N=204, Not yet recruiting, Sponsor: Boehringer Ingelheim
- ||| BI 1569912 / Boehringer Ingelheim
Trial completion: A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication (clinicaltrials.gov) - Nov 30, 2023
P1, N=59, Completed, Sponsor: Boehringer Ingelheim
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- || BI 1569912 / Boehringer Ingelheim
Enrollment closed: A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication (clinicaltrials.gov) - Nov 13, 2023
P1, N=59, Active, not recruiting, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || BI 1569912 / Boehringer Ingelheim
Enrollment closed: A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated (clinicaltrials.gov) - Oct 19, 2023
P1, N=56, Active, not recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- || BI 1569912 / Boehringer Ingelheim
Trial completion date, Trial primary completion date: A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated (clinicaltrials.gov) - Sep 5, 2023
P1, N=60, Recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting Trial completion date: Sep 2023 --> Dec 2023 | Trial primary completion date: Sep 2023 --> Dec 2023
- | BI 1569912 / Boehringer Ingelheim
Trial completion date, Trial primary completion date: A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated (clinicaltrials.gov) - Mar 7, 2023
P1, N=44, Recruiting, Sponsor: Boehringer Ingelheim
Trial completion date: Sep 2023 --> Dec 2023 | Trial primary completion date: Sep 2023 --> Dec 2023 Trial completion date: Mar 2023 --> Sep 2023 | Trial primary completion date: Mar 2023 --> Aug 2023
- ||| BI 1569912 / Boehringer Ingelheim
Enrollment open: A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated (clinicaltrials.gov) - Nov 8, 2022
P1, N=60, Recruiting, Sponsor: Boehringer Ingelheim
Trial completion date: Mar 2023 --> Sep 2023 | Trial primary completion date: Mar 2023 --> Aug 2023 Suspended --> Recruiting
- BI 1569912 / Boehringer Ingelheim
Safety, tolerability and pharmacokinetics of single rising doses of BI 1569912 in healthy males – a Phase I study (Corner 2 (Hall X1) [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_1465;
P1
Clearance was similar across all doses; accumulation after multiple doses is not expected. The mild AE profile and favourable PK observed here support the further clinical development of BI 1569912 for the treatment of MDD, given the current unmet clinical need.
- BI 1569912 / Boehringer Ingelheim
Safety, tolerability and pharmacokinetics of single rising doses of BI 1569912 in healthy males – a Phase I study (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_786;
P1
Clearance was similar across all doses; accumulation after multiple doses is not expected. The mild AE profile and favourable PK observed here support the further clinical development of BI 1569912 for the treatment of MDD, given the current unmet clinical need.
- BI 1569912 / Boehringer Ingelheim
Preclinical pharmacological characterisation of the selective NR2B negative allosteric modulator BI 1569912 with potential to treat major depressive disorder (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_762;
Its in vivo preclinical efficacy with favourable adverse effects profile indicates a promising therapeutic option for the treatment of MDD. Treatment with BI 1569912 is expected to relieve depressive symptoms in patients with MDD as a rapid-acting antidepressant with a larger therapeutic window compared with unselective NMDA blockers.
- BI 1569912 / Boehringer Ingelheim
Pharmacological effects of the novel NR2B modulator BI 1569912 on electroencephalography and eye-tracking in a Phase I study (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_593;
P1
Changes in MMN amplitude for duration and frequency deviants occurred at later timepoints (no available timepoint close to Tmax), which may indicate late or lasting effects of exposure, and could be relevant to the clinical efficacy of BI 1569912. Overall, these data indicate central target engagement by BI 1569912, and support further clinical development of the compound for the treatment of MDD.
- ||| BI 1569912 / Boehringer Ingelheim
Enrollment open: A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication (clinicaltrials.gov) - Sep 7, 2022
P1, N=66, Recruiting, Sponsor: Boehringer Ingelheim
Overall, these data indicate central target engagement by BI 1569912, and support further clinical development of the compound for the treatment of MDD. Suspended --> Recruiting
- BI 1569912 / Boehringer Ingelheim
Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of Bi 1569912 in Healthy Males: A Phase I Study () - May 6, 2022 - Abstract #SOBP2022SOBP_287;
Suspended --> Recruiting Preliminary data indicate that BI 1569912 was well tolerated across all doses.Plasma exposure of BI 1569912 increased dose-proportionally across the tested dose range.
- BI 1569912 / Boehringer Ingelheim
Preclinical Pharmacological Characterization of the Selective NR2b Negative Allosteric Modulator BI 1569912 With Potential to Treat MDD () - May 6, 2022 - Abstract #SOBP2022SOBP_286;
Taken together, these findings indicate that BI 1569912 is a potent and selective negative modulator of NMDA receptors. The vivo preclinical efficacy and favorable adverse effect profile of BI 1569912 suggests a promising therapeutic option for treatment of MDD.
- BI 1569912 / Boehringer Ingelheim
Pharmacological Effects of the Novel NR2B Modulator Bi 1569912 on Electroencephalography and Eye-Tracking in a Phase I Study () - May 6, 2022 - Abstract #SOBP2022SOBP_285;
P1
The vivo preclinical efficacy and favorable adverse effect profile of BI 1569912 suggests a promising therapeutic option for treatment of MDD. Treatment-dependent changes in resting state EEG and MMN readouts indicate central target engagement by BI 1569912, and support further clinical development of the compound.
- | BI 1569912 / Boehringer Ingelheim
Trial completion date, Trial primary completion date: A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated (clinicaltrials.gov) - Feb 10, 2022
P1, N=44, Recruiting, Sponsor: Boehringer Ingelheim
Treatment-dependent changes in resting state EEG and MMN readouts indicate central target engagement by BI 1569912, and support further clinical development of the compound. Trial completion date: Feb 2022 --> Feb 2023 | Trial primary completion date: Feb 2022 --> Feb 2023
- BI 1569912 / Boehringer Ingelheim
Trial completion date, Trial primary completion date: A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated (clinicaltrials.gov) - Dec 15, 2021
P1, N=60, Suspended, Sponsor: Boehringer Ingelheim
Trial completion date: Feb 2022 --> Feb 2023 | Trial primary completion date: Feb 2022 --> Feb 2023 Trial completion date: Jul 2022 --> Jul 2023 | Trial primary completion date: Jul 2022 --> Jul 2023
- BI 1569912 / Boehringer Ingelheim
Trial completion date, Trial primary completion date: A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication (clinicaltrials.gov) - Dec 13, 2021
P1, N=87, Suspended, Sponsor: Boehringer Ingelheim
Trial completion date: Jul 2022 --> Jul 2023 | Trial primary completion date: Jul 2022 --> Jul 2023 Trial completion date: May 2022 --> May 2023 | Trial primary completion date: Apr 2022 --> Apr 2023
- |||| BI 1569912 / Boehringer Ingelheim
Trial termination: A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood (clinicaltrials.gov) - Nov 12, 2021
P1, N=68, Terminated, Sponsor: Boehringer Ingelheim
Trial completion date: May 2022 --> May 2023 | Trial primary completion date: Apr 2022 --> Apr 2023 Suspended --> Terminated; Identification of potential mutagenic metabolite in human plasma
- |||| BI 1569912 / Boehringer Ingelheim
Trial suspension: A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication (clinicaltrials.gov) - Sep 27, 2021
P1, N=87, Suspended, Sponsor: Boehringer Ingelheim
Suspended --> Terminated; Identification of potential mutagenic metabolite in human plasma Recruiting --> Suspended
- |||| BI 1569912 / Boehringer Ingelheim
Trial suspension: A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood (clinicaltrials.gov) - Sep 24, 2021
P1, N=88, Suspended, Sponsor: Boehringer Ingelheim
Recruiting --> Suspended Recruiting --> Suspended
- |||| BI 1569912 / Boehringer Ingelheim
Trial suspension: A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated (clinicaltrials.gov) - Sep 17, 2021
P1, N=60, Suspended, Sponsor: Boehringer Ingelheim
Recruiting --> Suspended Recruiting --> Suspended
- || BI 1569912 / Boehringer Ingelheim
Enrollment open: A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated (clinicaltrials.gov) - Aug 12, 2021
P1, N=44, Recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Suspended Not yet recruiting --> Recruiting
- ||| BI 1569912 / Boehringer Ingelheim
Enrollment open: A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated (clinicaltrials.gov) - Aug 12, 2021
P1, N=60, Recruiting, Sponsor: Boehringer Ingelheim
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||| BI 1569912 / Boehringer Ingelheim
New P1 trial: A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated (clinicaltrials.gov) - Jul 27, 2021
P1, N=60, Not yet recruiting, Sponsor: Boehringer Ingelheim
- ||| BI 1569912 / Boehringer Ingelheim
Enrollment open: A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication (clinicaltrials.gov) - Jul 22, 2021
P1, N=87, Recruiting, Sponsor: Boehringer Ingelheim
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || BI 1569912 / Boehringer Ingelheim
New P1 trial: A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated (clinicaltrials.gov) - Jul 12, 2021
P1, N=44, Not yet recruiting, Sponsor: Boehringer Ingelheim
- ||| BI 1569912 / Boehringer Ingelheim
New P1 trial: A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication (clinicaltrials.gov) - Jun 24, 2021
P1, N=87, Not yet recruiting, Sponsor: Boehringer Ingelheim
- ||| BI 1569912 / Boehringer Ingelheim
Enrollment open: A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood (clinicaltrials.gov) - Aug 7, 2020
P1, N=88, Recruiting, Sponsor: Boehringer Ingelheim
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||| BI 1569912 / Boehringer Ingelheim
New P1 trial: A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood (clinicaltrials.gov) - Jun 23, 2020
P1, N=88, Not yet recruiting, Sponsor: Boehringer Ingelheim