Phase1, STP7 Cocaine Drug-Drug Interaction Study

Summary

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).

Conditions

• Cocaine Use Disorder

Interventions

DRUG

STP7 (mavoglurant)

STP7 (mavoglurant) twice a day (BID) from Days 3 to 9 according to the following dosing schedule: Day 3: 50 mg BID; Day 4: 100 mg BID; Days 5-9: 200 mg BID, and will take only the morning dose of STP7 (200 mg) on Day 10.

DRUG

Placebo

Placebo twice a day (BID) from Days 3 to 9, and will take only the morning dose of Placebo on Day 10.

DRUG

Cocaine Hydrochloride

Participants will undergo cocaine/saline i.v. challenge sessions according to the schedule and doses: * Screening (Session 1, Day -2): 20 mg cocaine, followed by a saline infusion, followed by 40 mg cocaine * Baseline (Session 2, Day 1): saline or 20 mg cocaine followed by either 20 mg cocaine or saline. * Baseline (Session 3, Day 2): saline or 40 mg cocaine followed by either 40 mg cocaine or saline. * Treatment (Session 4, Day 9): saline or 20 mg cocaine followed by either 20 mg cocaine or saline. * Treatment (Session 5, Day 10): saline or 40 mg cocaine followed by either 40 mg cocaine or saline.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Stalicla SA

  lead INDUSTRY

Principal Investigators

• Debra Kelsh, MD · Altasciences Clinical Kansas, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-15

Primary Completion

2024-10-07

Completion

2024-10-07

FDA Drug

Yes

Countries

• United States

Study Locations