A phase 1 study to assess potential interaction between ASP8062 and alcohol in healthy adult subjects

2022 ◽  
pp. 026988112110589
Author(s):  
Mototsugu Ito ◽  
Anna Spence ◽  
Mary Beth Blauwet ◽  
Nakyo Heo ◽  
Ronald Goldwater ◽  
...  
Keyword(s):  
Phase 1 ◽  
Pharmacokinetic Interaction ◽  
Opioid Use Disorder ◽  
Potential Interaction ◽  
Analysis Of Covariance ◽  
Opioid Use ◽  
Phase 1 Study ◽  
Double Blind ◽  
Pharmacodynamic Interaction ◽  
Crossover Phase

Background: ASP8062 is a novel orally active GABAB receptor positive allosteric modulator in clinical development for the treatment of alcohol use disorder (AUD) and opioid use disorder (OUD). Aims: This study assessed the potential pharmacokinetic/pharmacodynamic interaction between ASP8062 and alcohol under single-dose conditions in healthy adults. Methods: A double-blind, placebo-controlled, crossover phase 1 study was conducted in which 20 subjects were randomly assigned to four treatment sequences (ASP8062 + alcohol; ASP8062 + placebo alcohol; placebo + alcohol; placebo + placebo alcohol) each consisting of four treatment periods, separated by washout periods of at least 14 days. An analysis of variance was used to assess pharmacokinetic interaction and a mixed-effects analysis of covariance was used to assess pharmacodynamic interaction. Results/outcomes: After administration of alcohol, a mild to minimal increase in plasma exposure (AUCinf and Cmax) of ASP8062 was observed, but tmax and t½ for ASP8062 remained unchanged after administration of alcohol. In contrast, ASP8062 did not affect the AUClast and Cmax of ethanol. No clinically relevant differences in cognition measurements were observed with ASP8062 compared with placebo, but there were expected impairments in psychomotor and executive function with alcohol alone. ASP8062 in combination with alcohol resulted in worse scores in cognition measurements than alcohol alone, but this potentiation was not consistent. ASP8062 administered alone was safe and well-tolerated and safety findings in subjects administered alcohol alone were not augmented when ASP8062 was administered in combination with alcohol. Conclusion/interpretation: The data support further clinical studies investigating ASP8062 in patients with AUD.

Using Bilateral tDCS to Modulate EEG Amplitude and Coherence of Men With Opioid Use Disorder Under Methadone Therapy: A Sham-controlled Clinical Trial

2021 ◽  
pp. 155005942110221
Author(s):  
Hossein Mostafavi ◽  
Mohsen Dadashi ◽  
Alireza Faridi ◽  
Fatemeh Kazemzadeh ◽  
Zakaria Eskandari
Keyword(s):  
Clinical Trial ◽  
Quantitative Eeg ◽  
Opioid Use Disorder ◽  
Controlled Clinical Trial ◽  
Opioid Use ◽  
Double Blind ◽  
Theta Waves ◽  
Dorsolateral Prefrontal ◽  
Male Patients ◽  
The Right

Objective. This study aimed to investigate the effect of bilateral transcranial direct current stimulation (tDCS) on the electroencephalography (EEG) amplitude and coherence in male patients with opioid use disorder (OUD), who were under methadone therapy. It compares the effects of active versus sham tDCS. Methods. This is a double-blind sham-controlled clinical trial. Participants were 30 male patients with OUD; they were divided into 3 groups of left anode/right cathode tDCS, right anode/left cathode tDCS, and sham tDCS. Their brainwave activity was measured by quantitative EEG before study and then active groups underwent tDCS (2 mA, 20 min) applied over their right/left dorsolateral prefrontal cortex (DLPFC) for 10 consecutive days. After stimulation, they were re-assessed. The collected data were analyzed in SPSS, MATLAB, and NeuroGuide v.2 applications. Results. After active tDCS, a significant decrease in amplitude of slow brain waves (delta, theta, and alpha) in prefrontal, frontal, occipital, and parietal areas, and an increase in the coherence of beta, delta, and theta frequency bands in the parietal, central, and temporal regions of addicts were reported. In the sham group, there was a significant decrease in the amplitude of the alpha wave and in the coherence of delta and theta waves. Conclusion. The active tDCS over the right/left DLPFC, as a noninvasive and complementary treatment, can modulate the amplitude and coherence of brainwaves in patients with OUD.

A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study of Ad26.ZIKV.001, an Ad26-Vectored Anti–Zika Virus Vaccine

2021 ◽  
Author(s):  
Nadine C. Salisch ◽  
Kathryn E. Stephenson ◽  
Kristi Williams ◽  
Freek Cox ◽  
Leslie van der Fits ◽  
...  
Keyword(s):  
Virus Vaccine ◽  
Zika Virus ◽  
Phase 1 ◽  
Phase 1 Study ◽  
Double Blind

Are AutoCPAP Devices Reliable? A Double Blind Dummy Controlled Phase 1 Study

2010 ◽  
Author(s):  
Benny Mwenge ◽  
Myriam Dury ◽  
Pierre Delguste ◽  
Daniel Rodenstein
Keyword(s):  
Phase 1 ◽  
Phase 1 Study ◽  
Double Blind

ARASENS: A phase 3 trial of darolutamide in combination with docetaxel for men with metastatic hormone-sensitive prostate cancer (mHSPC).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. TPS383-TPS383 ◽  
Author(s):  
Matthew Raymond Smith ◽  
Fred Saad ◽  
Maha Hussain ◽  
Cora N. Sternberg ◽  
Karim Fizazi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase 1 ◽  
Performance Status ◽  
Physical Symptoms ◽  
Castration Resistant Prostate Cancer ◽  
Opioid Use ◽  
Phase 3 ◽  
Ecog Performance Status ◽  
Double Blind ◽  
Disease Extent

TPS383 Background: The addition of either docetaxel or abiraterone acetate plus prednisone to androgen deprivation therapy (ADT) improves overall survival (OS) compared with ADT alone in men with mHSPC. It is hypothesized that other androgen receptor (AR)-targeted therapies could be combined with docetaxel for mHSPC. Darolutamide (ODM-201) is an investigational oral AR antagonist with a unique chemical structure and negligible blood-brain barrier penetration that inhibits tumor growth by binding to AR and AR mutants (eg, W742L and F877L) with high affinity and specificity. In phase 1/2 ARADES and phase 1 ARAFOR trials, darolutamide demonstrated antitumor activity and was well tolerated in men with metastatic castration-resistant prostate cancer (mCRPC). ARASENS will evaluate the addition of darolutamide to standard ADT and docetaxel in men with mHSPC. Methods: This international, randomized, double-blind, placebo-controlled phase 3 trial (NCT02799602) is being conducted at > 300 sites in 23 countries. ~1300 men with newly diagnosed mHSPC will be randomized 1:1 to darolutamide (600 mg orally twice daily) or matching placebo. All patients will receive standard ADT + docetaxel (6 cycles). Patients will be stratified by disease extent and alkaline phosphatase level. Key inclusion criteria: histologically or cytologically confirmed PC with documented metastases, started ADT ± first-generation antiandrogen therapy ≤12 weeks before randomization, and ECOG performance status 0-1. The primary end point is OS. Secondary end points include time to mCRPC, initiation of subsequent anticancer therapy, symptomatic skeletal event (SSE)-free survival, time to first SSE, first opioid use, pain progression, and worsening of physical symptoms. Safety will be assessed. ARASENS is actively enrolling at > 280 sites across 23 countries. Clinical trial information: NCT02799602.

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