Cocaine Use DisorderPhase 1NCT06273540
Phase1, STP7 Cocaine Drug-Drug Interaction Study
A Phase 1 study testing STP7 (mavoglurant) and Cocaine Hydrochloride in people with Cocaine Use Disorder, run by Stalicla SA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- STP7 (mavoglurant) and Cocaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 7 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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:
- 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.
Who cannot join
- 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:
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- 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.
- Have any clinically significant finding on medical history, physical examination, clinical laboratory test, vital signs or ECGs that contraindicate participation in the study.
- 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.
- 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.).
- Have used any prescription drugs within 14 days of clinic intake or non-prescription drugs or herbal remedies within 7 days of clinic intake.
- 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.
- Have a positive serology for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCVab), or human immunodeficiency virus (HIV).
- Have positive results for a coronavirus disease 2019 (COVID-19) test performed after screening is complete and participant is confirmed, but prior to admission.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Kansas
Overland Park, Kansas, 66212
About this study
Official title: Phase 1, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess Potential Interactions Between Intravenous Cocaine and Oral STP7
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).
Read more
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
- Being tested
- STP7 (mavoglurant), Placebo, Cocaine Hydrochloride
- Keywords
- STP7, mavoglurant, Cocaine, AFQ056, metabotropic glutamate receptor 5, mGluR5, CUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STP7 (mavoglurant)Drug
Also called AFQ056
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.
PlaceboDrug
Placebo twice a day (BID) from Days 3 to 9, and will take only the morning dose of Placebo on Day 10.
Cocaine HydrochlorideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo; Drug: Cocaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events.
Any events spontaneously reported by the participant or observed by the investigative staff will also be recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Plasma concentration-time profiles of cocaine.
Measured: 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.
Plasma concentration-time profiles of benzoylecgonine.
Measured: 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.
Plasma concentration-time profiles of STP7.
Measured: 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.
Plasma concentration-time profiles of STP7.
Measured: 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.
Time to maximum plasma concentration of cocaine.
Measured: 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: time to maximum plasma concentration [Tmax] of benzoylecgonine.
Time to maximum plasma concentration of benzoylecgonine.
Measured: 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: time to maximum plasma concentration [Tmax] of STP7.
Time to maximum plasma concentration of STP7.
Measured: 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: time to maximum plasma concentration [Tmax] of STP7.
Time to maximum plasma concentration of STP7.
Measured: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: area under the concentration-time curve from time 0 to time t of cocaine.
Area under the concentration-time curve from time 0 to time t (AUC0-t) of cocaine.
Measured: 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: area under the concentration-time curve from time 0 to time t of benzoylecgonine.
Area under the concentration-time curve from time 0 to time t (AUC0-t) of benzoylecgonine.
Measured: 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: area under the concentration-time curve from time 0 to time of STP7.
Area under the concentration-time curve from time 0 to time t (AUC0-t) of STP7.
Measured: 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: area under the concentration-time curve from time 0 to time of STP7.
Area under the concentration-time curve from time 0 to time t (AUC0-t) of STP7.
Measured: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of cocaine.
Area under the concentration-time curve from time 0 to 12 hours post-dose (AUC0-12) of cocaine.
Measured: 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: area under the concentration-time curve from time 0 to 12 hours post-dose of benzoylecgonine.
Area under the concentration-time curve from time 0 to 12 hours post-dose (AUC0-12) of benzoylecgonine.
Measured: 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: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7.
Area under the concentration-time curve from time 0 to 12 hours post-dose (AUC0-12) of STP7.
Measured: 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: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7.
Area under the concentration-time curve from time 0 to 12 hours post-dose (AUC0-12) of STP7.
Measured: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of cocaine.
Area under the concentration-time curve from time 0 to time infinity post-dose of cocaine.
Measured: 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: area under the concentration-time curve from time 0 to time infinity post-dose of benzoylecgonine.
Area under the concentration-time curve from time 0 to time infinity post-dose of benzoylecgonine.
Measured: 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: area under the concentration-time curve from time 0 to time infinity post-dose of STP7.
Area under the concentration-time curve from time 0 to time infinity post-dose of STP7.
Measured: 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: area under the concentration-time curve from time 0 to time infinity post-dose of STP7.
Area under the concentration-time curve from time 0 to time infinity post-dose of STP7.
Measured: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: trough plasma concentration (Ctrough) of cocaine.
Trough plasma concentration (Ctrough) of cocaine.
Measured: 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: trough plasma concentration (Ctrough) of benzoylecgonine.
Trough plasma concentration (Ctrough) of benzoylecgonine.
Measured: 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: trough plasma concentration (Ctrough) of STP7.
Trough plasma concentration (Ctrough) of STP7.
Measured: 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: trough plasma concentration (Ctrough) of STP7.
Trough plasma concentration (Ctrough) of STP7.
Measured: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: terminal rate constant of cocaine.
Terminal rate constant of cocaine.
Measured: 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: terminal rate constant of benzoylecgonine.
Terminal rate constant of benzoylecgonine.
Measured: 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: terminal rate constant of STP7.
Terminal rate constant of STP7.
Measured: 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: terminal rate constant of STP7.
Terminal rate constant of STP7.
Measured: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: half-life of cocaine.
Half-life (t1/2) of cocaine
Measured: 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: half-life of benzoylecgonine.
Half-life (t1/2) of benzoylecgonine.
Measured: 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: half-life of STP7.
Half-life (t1/2) of STP7.
Measured: 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: half-life of STP7.
Half-life (t1/2) of STP7.
Measured: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: clearance of cocaine.
Clearance (CL) of cocaine.
Measured: 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: clearance of benzoylecgonine.
Clearance (CL) of benzoylecgonine.
Measured: 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: clearance of STP7.
Clearance (CL) of STP7.
Measured: 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: clearance of STP7.
Clearance (CL) of STP7.
Measured: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: Clearance from plasma after oral administration of cocaine.
Clearance from plasma after oral administration (CL/F) of cocaine.
Measured: 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: Clearance of benzoylecgonine from plasma after oral administration (CL/F) of cocaine.
Clearance of benzoylecgonine from plasma after oral administration (CL/F) of cocaine.
Measured: 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: Clearance from plasma after oral administration (CL/F) of STP7.
Clearance from plasma after oral administration (CL/F) of STP7.
Measured: 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: Clearance from plasma after oral administration (CL/F) of STP7.
Clearance from plasma after oral administration (CL/F) of STP7.
Measured: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Visual evaluation of the STP7 on the subjective effects of cocaine at screening
To evaluate whether STP7 treatment alters the subjective effects of cocaine measured by Visual Analog Scales (VAS).
Measured: Day -2: 30 minutes prior to cocaine infusion and at 5, 10, 15, 30, 45, 55, 65, 70, 75, 90, 105, 115, 125, 130, 135, 150, 165 and 180 minutes after the first infusion.
Visual evaluation of the STP7 on the subjective effects of cocaine at baseline and during treatment
To evaluate whether STP7 treatment alters the subjective effects of cocaine measured by Visual Analog Scales (VAS).
Measured: Day 1, day 2, day 9 and day 10: at -30, 5, 10, 15, 30, 45, 55, 65, 70, 75, 90, 105 and 120 minutes after the first infusion.
Craving evaluation of the STP7 on the subjective effects of cocaine.
To evaluate whether STP7 treatment alters the subjective effects of cocaine on craving measured by the score of the Brief Substance Craving Scale (BSCS).
Measured: Day -2, day 1, day 2, day 9 and day 10: at pre-infusion and 125 minutes after the start of the cocaine infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start15 Apr 2024
- Primary completion7 Oct 2024
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stalicla SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Debra Kelsh, MD, Principal investigator, Altasciences Company Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273540
- Sponsor's protocol ID
- STA-P7-C001
- Other IDs
- C-043-2023
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess Potential Interactions Between Intravenous Cocaine and Oral STP7
- ClinicalTrials.gov ID
- NCT06273540
- Acronym / sponsor ID
- STA-P7-C001
- Conditions
- Cocaine Use Disorder
- Keywords
- STP7, mavoglurant, Cocaine, AFQ056, metabotropic glutamate receptor 5, mGluR5, CUD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Stalicla SAIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STP7 (mavoglurant) modified release film-coated tablet | Experimental | Drug: STP7 (mavoglurant), Drug: Cocaine HydrochlorideParticipants 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. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Cocaine HydrochlorideParticipants 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STP7 (mavoglurant)Also: AFQ056STP7 (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 | STP7 (mavoglurant) modified release film-coated tablet |
| PlaceboPlacebo twice a day (BID) from Days 3 to 9, and will take only the morning dose of Placebo on Day 10. | Drug | Placebo |
| Cocaine HydrochlorideParticipants 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. | Drug | Placebo, STP7 (mavoglurant) modified release film-coated tablet |
Primary outcome
Incidence of Treatment-Emergent Adverse Events.
Time frame: 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).
Any events spontaneously reported by the participant or observed by the investigative staff will also be recorded.
Heart Rate response following the STP7 treatment with the cocaine infusion.
Time frame: 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
Change of the Heart Rate.
Heart Rate response following the STP7 treatment with the cocaine infusion.
Time frame: 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
Change of the Heart Rate.
Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion .
Time frame: 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
Change of the diastolic Blood Pressure.
Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion.
Time frame: 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
Change of the diastolic Blood Pressure.
Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion.
Time frame: 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
Change of the systolic Blood Pressure.
Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion.
Time frame: 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
Change of the systolic Blood Pressure.
ECG changes (HR) following the STP7 treatment with the cocaine infusion.
Time frame: 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.
Changes in ECG (HR) following STP7 treatment with the cocaine infusion at screening.
ECG changes (RR) following the STP7 treatment with the cocaine infusion.
Time frame: 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.
Changes in ECG (RR) following STP7 treatment with the cocaine infusion at screening.
ECG changes (PR) following the STP7 treatment with the cocaine infusion.
Time frame: 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.
Changes in ECG (PR) following STP7 treatment with the cocaine infusion at screening.
ECG changes (QRS) following the STP7 treatment with the cocaine infusion.
Time frame: 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.
Changes in ECG (QRS) following STP7 treatment with the cocaine infusion at screening.
ECG changes (QT) following the STP7 treatment with the cocaine infusion.
Time frame: 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.
Changes in ECG (QT) following STP7 treatment with the cocaine infusion at screening.
ECG changes (HR) following the STP7 treatment with the cocaine infusion.
Time frame: 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.
Changes in ECG (HR) following STP7 treatment with the cocaine infusion (baseline and treatment period).
ECG changes (RR) following the STP7 treatment with the cocaine infusion.
Time frame: 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.
Changes in ECG (RR) following STP7 treatment with the cocaine infusion (baseline and treatment period).
ECG changes (PR) following the STP7 treatment with the cocaine infusion.
Time frame: 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.
Changes in ECG (PR) following STP7 treatment with the cocaine infusion (baseline and treatment period).
ECG changes (QRS) following the STP7 treatment with the cocaine infusion.
Time frame: 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.
Changes in ECG (QRS) following STP7 treatment with the cocaine infusion (baseline and treatment period).
ECG changes (QT) following the STP7 treatment with the cocaine infusion.
Time frame: 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.
Changes in ECG (QT) following STP7 treatment with the cocaine infusion (baseline and treatment period).
43 secondary outcomes
Pharmacokinetics: Maximum Plasma Concentration [Cmax] of cocaine.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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: time to maximum plasma concentration [Tmax] of benzoylecgonine.
Time frame: 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: time to maximum plasma concentration [Tmax] of STP7.
Time frame: 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: time to maximum plasma concentration [Tmax] of STP7.
Time frame: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: area under the concentration-time curve from time 0 to time t of cocaine.
Time frame: 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: area under the concentration-time curve from time 0 to time t of benzoylecgonine.
Time frame: 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: area under the concentration-time curve from time 0 to time of STP7.
Time frame: 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: area under the concentration-time curve from time 0 to time of STP7.
Time frame: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of cocaine.
Time frame: 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: area under the concentration-time curve from time 0 to 12 hours post-dose of benzoylecgonine.
Time frame: 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: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7.
Time frame: 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: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7.
Time frame: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of cocaine.
Time frame: 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: area under the concentration-time curve from time 0 to time infinity post-dose of benzoylecgonine.
Time frame: 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: area under the concentration-time curve from time 0 to time infinity post-dose of STP7.
Time frame: 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: area under the concentration-time curve from time 0 to time infinity post-dose of STP7.
Time frame: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: trough plasma concentration (Ctrough) of cocaine.
Time frame: 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: trough plasma concentration (Ctrough) of benzoylecgonine.
Time frame: 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: trough plasma concentration (Ctrough) of STP7.
Time frame: 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: trough plasma concentration (Ctrough) of STP7.
Time frame: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: terminal rate constant of cocaine.
Time frame: 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: terminal rate constant of benzoylecgonine.
Time frame: 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: terminal rate constant of STP7.
Time frame: 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: terminal rate constant of STP7.
Time frame: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: half-life of cocaine.
Time frame: 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: half-life of benzoylecgonine.
Time frame: 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: half-life of STP7.
Time frame: 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: half-life of STP7.
Time frame: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: clearance of cocaine.
Time frame: 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: clearance of benzoylecgonine.
Time frame: 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: clearance of STP7.
Time frame: 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: clearance of STP7.
Time frame: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Pharmacokinetics: Clearance from plasma after oral administration of cocaine.
Time frame: 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: Clearance of benzoylecgonine from plasma after oral administration (CL/F) of cocaine.
Time frame: 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: Clearance from plasma after oral administration (CL/F) of STP7.
Time frame: 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: Clearance from plasma after oral administration (CL/F) of STP7.
Time frame: Day 10, at pre-dose, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Kelsh, MD principal investigator
Altasciences Company Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STP7 (mavoglurant) and Cocaine Hydrochloride in people with Cocaine Use Disorder, run by Stalicla SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events. (time frame: 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).). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.