Phase1, STP7 Cocaine Drug-Drug Interaction Study

NCT ID: NCT06273540

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2024-10-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

STP7 (mavoglurant) modified release film-coated tablet

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.

Group Type: EXPERIMENTAL

STP7 (mavoglurant)

Intervention Type: 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.

Cocaine / Saline

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Cocaine / Saline

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.

Interventions

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.

Cocaine / Saline

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.

Intervention Type: DRUG

Placebo

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

Cocaine / Saline

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.

Intervention Type: DRUG

Other Intervention Names

Cocaine; Saline infusion; Cocaine; Saline infusion

Eligibility Criteria

Inclusion Criteria

1. Be participants who are cocaine-experienced and not seeking treatment for cocaine use disorder.

2. Males and females between 18 and 59 years of age, inclusive.

3. 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.

4. 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.

5. Provide a urine sample positive for cocaine at least once during screening (Days -28 to -4).

6. Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.

7. 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.

8. Be able to comply with protocol requirements, rules and regulations of the study site, and be likely to complete all the study treatments.

Exclusion Criteria

1. 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.

2. Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, paranoid reaction or seizure.

3. Have clinically significant findings in the opinion of an investigator based on the MINI (version 7.0) neuropsychiatric interview.

4. Be pregnant or lactating.

5. 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.

6. 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.

7. 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.

8. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening.

9. Plasma donation within 7 days prior to screening.

10. Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening.

11. Have consumed grapefruit or other foods that inhibit or induce CYP3A4 within 7 days of Study Day 1.

12. Have any clinically significant finding on medical history, physical examination, clinical laboratory test, vital signs or ECGs that contraindicate participation in the study.

13. Have a history of suicide attempts or current or recent evidence of suicidal ideation in the past 12 months based on the Columbia-Suicide Severity Rating Scale.

14. Have a positive urine drug screen upon clinic intake (Day -3) for any of the following drugs: alcohol, amphetamine/methamphetamine, barbiturates, benzodiazepines, buprenorphine, cocaine, fentanyl, 3,4 methylenedioxymethamphetamine (MDMA), methadone, phencyclidine/phenylcyclohexyl piperidine (PCP), propoxyphene, and opioids (e.g., codeine, heroin, morphine, oxycodone, etc.).

15. Have used any prescription drugs within 14 days of clinic intake or non-prescription drugs or herbal remedies within 7 days of clinic intake.

16. Be unable to distinguish between a 20 mg and 40 mg dose of cocaine i.v. based on the high effects VAS at either the 5 or 10 minute time point during the screening infusion.

17. Have a positive serology for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCVab), or human immunodeficiency virus (HIV).

18. Have positive results for a coronavirus disease 2019 (COVID-19) test performed after screening is complete and participant is confirmed, but prior to admission.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Stalicla SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debra Kelsh, MD

Role: PRINCIPAL_INVESTIGATOR

Altasciences Clinical Kansas, Inc.

Locations

Altasciences Clinical Kansas

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

C-043-2023

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STA-P7-C001

Identifier Type: -

Identifier Source: org_study_id