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- ANS-6637 / Amygdala Neurosci
Phase 2 Study of ANS-6637, a Specific Inhibitor of ALDH2, in Treatment Seeking Individuals With Alcohol Use Disorder: A Combined Human Laboratory and Outpatient Clinical Trial ([VIRTUAL]) - Nov 28, 2021 - Abstract #ACNP2021ACNP_967;
In addition, while the effects on alcohol craving measured in response to an alcohol cue-exposure paradigm after 1-week of dosing were small, data from the participants treated for 5 weeks provide preliminary evidence suggesting that selective ALDH2 inhibition may reduce drinking, alcohol consequences and craving. However, these results must be interpreted with caution as the effect sizes could be unreliable due to the small sample size.
- ANS-6637 / Amygdala Neurosci
Phase 2 Study of ANS-6637, a Specific Inhibitor of ALDH2, in Treatment Seeking Individuals With Alcohol Use Disorder: A Combined Human Laboratory and Outpatient Clinical Trial (Exhibit Hall C) - Nov 28, 2021 - Abstract #ACNP2021ACNP_262;
In addition, while the effects on alcohol craving measured in response to an alcohol cue-exposure paradigm after 1-week of dosing were small, data from the participants treated for 5 weeks provide preliminary evidence suggesting that selective ALDH2 inhibition may reduce drinking, alcohol consequences and craving. However, these results must be interpreted with caution as the effect sizes could be unreliable due to the small sample size.
- || ANS-6637 / Amygdala Neurosci
Clinical, Journal: Interaction of Ethanol and Oral ANS-6637, a Selective ALDH2 Inhibitor in Males: A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Cohort Study. (Pubmed Central) - Oct 9, 2021
A single oral dose of ANS-6637 with up to 5 standards drinks over 2.5 hrs was generally well tolerated in healthy males. The most common pharmacological response was flushing and an increase in HR, which are known effects of acetaldehyde accumulation and consistent with inhibition of ADLH2 with oral ANS-6637 in combination with alcohol. The results of this alcohol interaction study support further testing of ANS-6637 in individuals with substance use disorders who may consume alcohol.
- || ANS-6637 / Amygdala Neurosci
Clinical, PK/PD data, Journal: The Effect of GS-548351 on the Pharmacokinetics of Midazolam Following Multiple Doses of ANS-6637 in Healthy Adults. (Pubmed Central) - Aug 7, 2021
A single grade 3 adverse event (alanine aminotransferase elevation) was identified and resolved following discontinuation of the study drug. Overall, multidose ANS-6637 was well tolerated and did not alter the PK of midazolam beyond a small increase in AUC that is unlikely to be clinically significant.
- | ANS-6637 / Amygdala Neurosci
Enrollment change, Trial withdrawal: Development of a Selective ALDH2 Inhibitor to Treat AUD (clinicaltrials.gov) - May 25, 2021
P2, N=0, Withdrawn, Sponsor: University of California, Los Angeles
Overall, multidose ANS-6637 was well tolerated and did not alter the PK of midazolam beyond a small increase in AUC that is unlikely to be clinically significant. N=75 --> 0 | Not yet recruiting --> Withdrawn
- | ANS-6637 / Amygdala Neurosci
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder (clinicaltrials.gov) - Jan 28, 2021
P2, N=0, Withdrawn, Sponsor: University of Maryland, Baltimore
N=75 --> 0 | Not yet recruiting --> Withdrawn N=82 --> 0 | Trial completion date: Dec 2021 --> Jan 2021 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2021 --> Jan 2021
- | ANS-6637 / Amygdala Neurosci
Trial completion date, Trial primary completion date: Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder (clinicaltrials.gov) - Dec 11, 2020
P2, N=82, Not yet recruiting, Sponsor: University of Maryland, Baltimore
N=82 --> 0 | Trial completion date: Dec 2021 --> Jan 2021 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2021 --> Jan 2021 Trial completion date: May 2021 --> Dec 2021 | Trial primary completion date: May 2021 --> Dec 2021
- | ANS-6637 / Amygdala Neurosci
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: HLAB-002 of ANS-6637 for Alcohol Use Disorder (clinicaltrials.gov) - Sep 2, 2020
P2, N=43, Terminated, Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Trial completion date: May 2021 --> Dec 2021 | Trial primary completion date: May 2021 --> Dec 2021 N=81 --> 43 | Trial completion date: Dec 2020 --> Jul 2020 | Suspended --> Terminated | Trial primary completion date: Nov 2020 --> Jul 2020; The study was terminated early following enrollment of n=43 due to clinically significant increases in liver enzymes in 3 women following at least 3 weeks of dosing with both doses of ANS-6637.
- ANS 6637 / Amygdala Neurosci, ANS-6637 / Amygdala Neurosci
[VIRTUAL] Cardiovascular Safety of ANS-6637, a Reversible, Selective Aldehyde Dehydrogenase-2 Inhibitor to Treat Cocaine Use Disorder () - Jun 13, 2020 - Abstract #CPDD2020CPDD_572;
Disulfiram, a nonselective ALDH and dopamine beta-hydroxylase inhibitor, decreased cocaine use in clinical trials, but it increased QT interval after ethanol (cocaine and alcohol are frequently used together). These studies suggest it may be safe to evaluate the effects of ANS-6637 in human clinical studies in combination with cocaine.
- | ANS-6637 / Amygdala Neurosci
Trial suspension: HLAB-002 of ANS-6637 for Alcohol Use Disorder (clinicaltrials.gov) - Jun 4, 2020
P2, N=81, Suspended, Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
These studies suggest it may be safe to evaluate the effects of ANS-6637 in human clinical studies in combination with cocaine. Active, not recruiting --> Suspended
- | ANS-6637 / Amygdala Neurosci
Enrollment closed: HLAB-002 of ANS-6637 for Alcohol Use Disorder (clinicaltrials.gov) - Apr 9, 2020
P2, N=81, Active, not recruiting, Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Active, not recruiting --> Suspended Recruiting --> Active, not recruiting
- | ANS-6637 / Amygdala Neurosci
Trial initiation date: Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder (clinicaltrials.gov) - Mar 24, 2020
P2, N=82, Not yet recruiting, Sponsor: University of Maryland, Baltimore
Recruiting --> Active, not recruiting Initiation date: Jan 2020 --> Aug 2020
- | ANS-6637 / Amygdala Neurosci
New P2 trial: Development of a Selective ALDH2 Inhibitor to Treat AUD (clinicaltrials.gov) - Mar 16, 2020
P2, N=75, Not yet recruiting, Sponsor: University of California, Los Angeles
- | ANS-6637 / Amygdala Neurosci
Trial completion, Enrollment change: The Influence of ANS-6637 on Midazolam Pharmacokinetics in Healthy Volunteers (clinicaltrials.gov) - Jan 2, 2020
P1, N=26, Completed, Sponsor: National Institutes of Health Clinical Center (CC)
Initiation date: Jan 2020 --> Aug 2020 Active, not recruiting --> Completed | N=50 --> 26
- | ANS-6637 / Amygdala Neurosci
New P2 trial: Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder (clinicaltrials.gov) - Nov 18, 2019
P2, N=82, Not yet recruiting, Sponsor: University of Maryland, Baltimore
- | ANS-6637 / Amygdala Neurosci
Enrollment open, Trial completion date, Trial primary completion date: HLAB-002 of ANS-6637 for Alcohol Use Disorder (clinicaltrials.gov) - Oct 2, 2019
P2, N=81, Recruiting, Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Active, not recruiting --> Completed | N=50 --> 26 Not yet recruiting --> Recruiting | Trial completion date: Sep 2020 --> Dec 2020 | Trial primary completion date: Aug 2020 --> Nov 2020
- | ANS-6637 / Amygdala Neurosci
Trial initiation date: HLAB-002 of ANS-6637 for Alcohol Use Disorder (clinicaltrials.gov) - Sep 4, 2019
P2, N=81, Not yet recruiting, Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Not yet recruiting --> Recruiting | Trial completion date: Sep 2020 --> Dec 2020 | Trial primary completion date: Aug 2020 --> Nov 2020 Initiation date: Jul 2019 --> Oct 2019
- | ANS-6637 / Amygdala Neurosci
Trial completion date: The Influence of ANS-6637 on Midazolam Pharmacokinetics in Healthy Volunteers (clinicaltrials.gov) - Aug 21, 2019
P1, N=50, Active, not recruiting, Sponsor: National Institutes of Health Clinical Center (CC)
Initiation date: Jul 2019 --> Oct 2019 Trial completion date: Aug 2019 --> Jan 2020
- | ANS-6637 / Amygdala Neurosci
New P2 trial: HLAB-002 of ANS-6637 for Alcohol Use Disorder (clinicaltrials.gov) - May 30, 2019
P2, N=81, Not yet recruiting, Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- | ANS-6637 / Amygdala Neurosci
Enrollment closed: The Influence of ANS-6637 on Midazolam Pharmacokinetics in Healthy Volunteers (clinicaltrials.gov) - May 22, 2019
P1, N=50, Active, not recruiting, Sponsor: National Institutes of Health Clinical Center (CC)
Trial completion date: Aug 2019 --> Jan 2020 Recruiting --> Active, not recruiting
- | ANS-6637 / Amygdala Neurosci
New P1 trial: The Influence of ANS-6637 on Midazolam Pharmacokinetics in Healthy Volunteers (clinicaltrials.gov) - Feb 6, 2019
P1, N=50, Recruiting, Sponsor: National Institutes of Health Clinical Center (CC)
- | ANS-6637 / Amygdala Neurosci
Trial completion, Trial initiation date: A Study to Evaluate the Safety of the Coadministration of ANS-6637 and Ethanol (clinicaltrials.gov) - Jan 17, 2018
P1b, N=48, Completed, Sponsor: Amygdala Neurosciences, Inc.
Recruiting --> Active, not recruiting Recruiting --> Completed | Initiation date: Jul 2017 --> Feb 2017
- | ANS-6637 / Amygdala Neurosci
Enrollment open: A Study to Evaluate the Safety of the Coadministration of ANS-6637 and Ethanol (clinicaltrials.gov) - Jul 30, 2017
P1b, N=48, Recruiting, Sponsor: Amygdala Neurosciences, Inc.
Recruiting --> Completed | Initiation date: Jul 2017 --> Feb 2017 Not yet recruiting --> Recruiting
- | ANS-6637 / Amygdala Neurosci
New P1 trial: A Study to Evaluate the Safety of the Coadministration of ANS-6637 and Ethanol (clinicaltrials.gov) - Jun 29, 2017
P1b, N=48, Not yet recruiting, Sponsor: Amygdala Neurosciences, Inc.