Phase1, STP7 Cocaine Drug-Drug Interaction Study

NCT06273540 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: STA-P7-C001C-043-2023
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

STP7; mavoglurant; Cocaine; AFQ056; metabotropic glutamate receptor 5; mGluR5; CUD

Outcome Measures

Primary Outcomes (17)

• Incidence of Treatment-Emergent Adverse Events.

  Any events spontaneously reported by the participant or observed by the investigative staff will also be recorded.

  On day -2, day -1, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day10, day 11, day 12 and the follow-up (window from day 19 to day 26).

• Heart Rate response following the STP7 treatment with the cocaine infusion.

  Change of the Heart Rate.

  Collected at day -2 at the time points (relative to the first infusion of the day): -30, - 15, 5, 10, 15, 20, 25, 30, 45, 55, 65, 70, 75, 80, 85, 90, 105, 115, 125, 130, 135, 140, 145, 150, 165, 180, 210, 240, 270, 300, 330 and 360 minutes

• Heart Rate response following the STP7 treatment with the cocaine infusion.

  Change of the Heart Rate.

  Collected at day 1, day 2, day 9 and day 10 at the time points (relative to the first infusion of the day): -30, -15, 5, 10, 15, 20, 25, 30, 45, 55, 65, 70, 75, 80, 85, 90, 105, 120, 150, 180, 210, 240, 270 and 300 minutes

• Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion .

  Change of the diastolic Blood Pressure.

  Collected at day -2 at the time points (relative to the first infusion of the day): -30, - 15, 5, 10, 15, 20, 25, 30, 45, 55, 65, 70, 75, 80, 85, 90, 105, 115, 125, 130, 135, 140, 145, 150, 165, 180, 210, 240, 270, 300, 330 and 360 minutes

• Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion.

  Change of the diastolic Blood Pressure.

  Collected at day 1, day 2, day 9 and day 10 at the time points (relative to the first infusion of the day): -30, -15, 5, 10, 15, 20, 25, 30, 45, 55, 65, 70, 75, 80, 85, 90, 105, 120, 150, 180, 210, 240, 270 and 300 minutes

• Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion.

  Change of the systolic Blood Pressure.

  Collected at day -2 at the time points (relative to the first infusion of the day): -30, - 15, 5, 10, 15, 20, 25, 30, 45, 55, 65, 70, 75, 80, 85, 90, 105, 115, 125, 130, 135, 140, 145, 150, 165, 180, 210, 240, 270, 300, 330 and 360 minutes

• Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion.

  Change of the systolic Blood Pressure.

  Collected at day 1, day 2, day 9 and day 10 at the time points (relative to the first infusion of the day): -30, -15, 5, 10, 15, 20, 25, 30, 45, 55, 65, 70, 75, 80, 85, 90, 105, 120, 150, 180, 210, 240, 270 and 300 minutes

• ECG changes (HR) following the STP7 treatment with the cocaine infusion.

  Changes in ECG (HR) following STP7 treatment with the cocaine infusion at screening.

  As collected at day -2 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 105, 125, 130, 135, 150, 165, 180 and 360 minutes after the first infusion.

• ECG changes (RR) following the STP7 treatment with the cocaine infusion.

  Changes in ECG (RR) following STP7 treatment with the cocaine infusion at screening.

  As collected at day -2 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 105, 125, 130, 135, 150, 165, 180 and 360 minutes after the first infusion.

• ECG changes (PR) following the STP7 treatment with the cocaine infusion.

  Changes in ECG (PR) following STP7 treatment with the cocaine infusion at screening.

  As collected at day -2 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 105, 125, 130, 135, 150, 165, 180 and 360 minutes after the first infusion.

• ECG changes (QRS) following the STP7 treatment with the cocaine infusion.

  Changes in ECG (QRS) following STP7 treatment with the cocaine infusion at screening.

  As collected at day -2 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 105, 125, 130, 135, 150, 165, 180 and 360 minutes after the first infusion.

• ECG changes (QT) following the STP7 treatment with the cocaine infusion.

  Changes in ECG (QT) following STP7 treatment with the cocaine infusion at screening.

  As collected at day -2 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 105, 125, 130, 135, 150, 165, 180 and 360 minutes after the first infusion.

• ECG changes (HR) following the STP7 treatment with the cocaine infusion.

  Changes in ECG (HR) following STP7 treatment with the cocaine infusion (baseline and treatment period).

  As collected at day 1, day 2, day 9 and day 10 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 120, 150, 180 and 300 minutes after the first infusion.

• ECG changes (RR) following the STP7 treatment with the cocaine infusion.

  Changes in ECG (RR) following STP7 treatment with the cocaine infusion (baseline and treatment period).

  As collected at day 1, day 2, day 9 and day 10 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 120, 150, 180 and 300 minutes after the first infusion.

• ECG changes (PR) following the STP7 treatment with the cocaine infusion.

  Changes in ECG (PR) following STP7 treatment with the cocaine infusion (baseline and treatment period).

  As collected at day 1, day 2, day 9 and day 10 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 120, 150, 180 and 300 minutes after the first infusion.

• ECG changes (QRS) following the STP7 treatment with the cocaine infusion.

  Changes in ECG (QRS) following STP7 treatment with the cocaine infusion (baseline and treatment period).

  As collected at day 1, day 2, day 9 and day 10 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 120, 150, 180 and 300 minutes after the first infusion.

• ECG changes (QT) following the STP7 treatment with the cocaine infusion.

  Changes in ECG (QT) following STP7 treatment with the cocaine infusion (baseline and treatment period).

  As collected at day 1, day 2, day 9 and day 10 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 120, 150, 180 and 300 minutes after the first infusion.

Secondary Outcomes (43)

• Pharmacokinetics: Maximum Plasma Concentration [Cmax] of cocaine.

  Day 2 and day 10: at 15 minutes before the first infusion, and at 5, 15, 30, 65, 75, 90, 120, 150, and 180 minutes, and at 4, 8, 12, 20 and 32 hours after the first infusion.

• Pharmacokinetics: Maximum Plasma Concentration [Cmax] of benzoylecgonine.

  Day 2 and day 10: at 15 minutes before the first infusion, and at 5, 15, 30, 65, 75, 90, 120, 150, and 180 minutes, and at 4, 8, 12, 20 and 32 hours after the first infusion.

• Pharmacokinetics: Maximum Plasma Concentration [Cmax] of STP7.

  Day 5, day 6, day 7, day 8 and day 9: prior to the morning dose and 4 hours post-dose for each day.

• Pharmacokinetics: Maximum Plasma Concentration [Cmax] of STP7.

  Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.

• Pharmacokinetics: time to maximum plasma concentration [Tmax] of cocaine.

  Day 2 and day 10: at 15 minutes before the first infusion, and at 5, 15, 30, 65, 75, 90, 120, 150, and 180 minutes, and at 4, 8, 12, 20 and 32 hours after the first infusion.

Study Arms (2)

STP7 (mavoglurant) modified release film-coated tablet

EXPERIMENTAL

Participants will take 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, * Day 10: 200 mg only the morning dose. Morning STP7 (mavoglurant) doses must be taken within 30 minutes of beginning a meal.

Drug: STP7 (mavoglurant); Drug: Cocaine Hydrochloride

Placebo

PLACEBO COMPARATOR

Participants will take matched placebo twice a day (BID) from Days 3 to 9 and only the morning dose on Day 10. Morning Placebo must be taken within 30 minutes of beginning a meal.

Drug: Placebo; Drug: Cocaine Hydrochloride

Interventions

STP7 (mavoglurant) DRUG

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.

Also known as: AFQ056

STP7 (mavoglurant) modified release film-coated tablet

Cocaine Hydrochloride DRUG

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.

Placebo; STP7 (mavoglurant) modified release film-coated tablet

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be participants who are cocaine-experienced and not seeking treatment for cocaine use disorder.
• Males and females between 18 and 59 years of age, inclusive.
• Have a body mass index (BMI) within a range of 17.0 to 36.0 kg/m2 and a minimum weight of at least 50.0 kg at screening.
• Have experience using cocaine by the smoked or i.v. route at least 6 times in the past 12 months prior to clinic intake (Day -3) and at least one use (smoked, i.v., or nasal route) within the past 3 months.
• Provide a urine sample positive for cocaine at least once during screening (Days -28 to -4).
• Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
• A female study participant must meet one of the following criteria:
• If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first administration of the study medication, during the study, and for at least 30 days after the last dose of the study medication. An acceptable method of contraception includes one of the following:
• i. Abstinence from heterosexual intercourse ii. Hormonal contraceptives (injectable/implant/insertable hormonal birth control products, transdermal patch) iii. Intrauterine device (with or without hormones) OR agrees to use a double barrier method (e.g. condom and spermicide) during the study and for at least 30 days after the last dose of the study medication. If a female of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses), as confirmed by FSH levels.
• A male study participant that engages in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g. condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication.
• Be able to comply with protocol requirements, rules and regulations of the study site, and be likely to complete all the study treatments.

You may not qualify if:

• Have a current or past history of seizure disorder, including alcohol- or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
• Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, paranoid reaction or seizure.
• Have clinically significant findings in the opinion of an investigator based on the MINI (version 7.0) neuropsychiatric interview.
• Be pregnant or lactating.
• Have a sitting systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg and heart rate \> 100 beats per minute at screening and clinic intake.
• Have a history of liver disease or current elevation of liver function test (LFT) values as follows:
• aspartate aminotransferase (AST) \>2x the upper limit of normal
• alanine aminotransferase (ALT) \>2 × the upper limit of normal.
• Have a history of renal disease or current renal function test values as follows:
• blood urea nitrogen (BUN) \>2× ULN, or
• creatinine \>1.5 mg/dL.
• Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening.
• Plasma donation within 7 days prior to screening.
• Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening.
• Have consumed grapefruit or other foods that inhibit or induce CYP3A4 within 7 days of Study Day 1.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Stalicla SA: lead

Study Sites (1)

Altasciences Clinical Kansas

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Interventions

mavoglurant; Cocaine

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Debra Kelsh, MD

  Altasciences Clinical Kansas, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: February 22, 2024
• Study Start: April 15, 2024
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)