protocolSection identificationModule nctId: NCT06273540, orgStudyIdInfo id: STA-P7-C001, briefTitle: Phase1, STP7 Cocaine Drug-Drug Interaction Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Stalicla SA, class: INDUSTRY, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This is a double-blind, placebo-controlled, parallel group study to compare the effects of STP7 (mavoglurant) vs placebo control on i.v. cocaine's physiological and subjective effects in non-treatment seeking, cocaine-experienced males or females participants between 18 and 59 years of age.The primary objective of this study is to determine if there are clinically meaningful interactions between oral STP7 (mavoglurant) treatment concurrent with 20 and 40 mg i.v. cocaine infusions by measuring adverse events and cardiovascular responses including heart rate, blood pressure, and electrocardiogram (including corrected QT interval).The secondary objectives are:* To evaluate whether administration of STP7 (mavoglurant) alters the pharmacokinetics of cocaine and/or its major metabolite, benzoylecgonine.* To determine the pharmacokinetic of STP7 (mavoglurant) administered at a dose of 200 mg twice a day.* To evaluate whether STP7 (mavoglurant) treatment alters the subjective effects of cocaine measured by Visual Analog Scales (VAS) and Brief Substance Craving Scale (BSCS)., conditionsModule conditions: Cocaine Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: STP7 (mavoglurant) or Placebo, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events., primaryOutcomes measure: Heart Rate response following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: Heart Rate response following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion ., primaryOutcomes measure: Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (HR) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (RR) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (PR) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (QRS) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (QT) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (HR) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (RR) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (PR) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (QRS) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (QT) following the STP7 treatment with the cocaine infusion., secondaryOutcomes measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of cocaine., secondaryOutcomes measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of STP7., secondaryOutcomes measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of STP7., secondaryOutcomes measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of cocaine., secondaryOutcomes measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of STP7., secondaryOutcomes measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of STP7., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time t of cocaine., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time t of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time of STP7., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time of STP7., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of cocaine., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of cocaine., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of STP7., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of STP7., secondaryOutcomes measure: Pharmacokinetics: trough plasma concentration (Ctrough) of cocaine., secondaryOutcomes measure: Pharmacokinetics: trough plasma concentration (Ctrough) of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: trough plasma concentration (Ctrough) of STP7., secondaryOutcomes measure: Pharmacokinetics: trough plasma concentration (Ctrough) of STP7., secondaryOutcomes measure: Pharmacokinetics: terminal rate constant of cocaine., secondaryOutcomes measure: Pharmacokinetics: terminal rate constant of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: terminal rate constant of STP7., secondaryOutcomes measure: Pharmacokinetics: terminal rate constant of STP7., secondaryOutcomes measure: Pharmacokinetics: half-life of cocaine., secondaryOutcomes measure: Pharmacokinetics: half-life of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: half-life of STP7., secondaryOutcomes measure: Pharmacokinetics: half-life of STP7., secondaryOutcomes measure: Pharmacokinetics: clearance of cocaine., secondaryOutcomes measure: Pharmacokinetics: clearance of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: clearance of STP7., secondaryOutcomes measure: Pharmacokinetics: clearance of STP7., secondaryOutcomes measure: Pharmacokinetics: Clearance from plasma after oral administration of cocaine., secondaryOutcomes measure: Pharmacokinetics: Clearance of benzoylecgonine from plasma after oral administration (CL/F) of cocaine., secondaryOutcomes measure: Pharmacokinetics: Clearance from plasma after oral administration (CL/F) of STP7., secondaryOutcomes measure: Pharmacokinetics: Clearance from plasma after oral administration (CL/F) of STP7., secondaryOutcomes measure: Visual evaluation of the STP7 on the subjective effects of cocaine at screening, secondaryOutcomes measure: Visual evaluation of the STP7 on the subjective effects of cocaine at baseline and during treatment, secondaryOutcomes measure: Craving evaluation of the STP7 on the subjective effects of cocaine., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Altasciences Clinical Kansas, status: RECRUITING, city: Overland Park, state: Kansas, zip: 66212, country: United States, contacts name: Debra Kelsh, MD, role: CONTACT, geoPoint lat: 38.98223, lon: -94.67079, hasResults: False