Alcohol interaction trial enhanced with responsive, collaborative approach, says CRO
An Altasciences company, Vince & Associates Clinical Research is a contract research organization (CRO) based in Overland Park, KS.
The proof-of-concept, dose-ranging study will evaluate the safety of the co-administration of ascending doses of ANS-6637 and ethanol in healthy male alcohol drinkers, according to the company.
Amygdala Neurosciences Inc. acquired ANS-6637 (previously GS-6637) from Gilead Sciences, Inc. earlier this year. Its potential clinical indication is the treatment of substance abuse, including alcohol and cocaine dependence.
As for the challenges of conducting the trial, Bradley Vince, D.O., CEO and medical director at Vince & Associates Clinical Research told us the study requires “significant investigator and clinical operations staffing secondary to the necessary safety monitoring and medical hypervigilance.”
Additionally, recruitment will also be a challenge – as it is across the industry – though specifically, the alcohol interaction trial will require recruitment of qualified volunteers that meet protocol specified eligibility with respect to alcohol consumption history, Vince explained.
“It is imperative to utilize a CRO with significant expertise in special populations as well as depth in the Investigator staff secondary to the extensive medical procedures required in alcohol interaction trials,” he added.
“Further, a responsive and collaborative approach by the sponsor with respect to dose escalations further enhances the successful study conduct of these complex clinical trials,” said Vince.
The CRO has completed five of six dosing cohorts.
