Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT06648668
Eligibility Criteria:
Inclusion Criteria:
1. Males and females between 18 and 55 years of age, inclusive.
2. Understand the study procedures, follow instructions, and provide written informed consent.
3. Have a body mass index (BMI) within a range of 18.0 to 34.0 kg/m2 and body weight ≥50.0 kg at Screening.
4. Healthy, as determined by no clinically significant medical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory results (including hematology, clinical chemistry, urinalysis, and serology) at Screening, as judged by the investigator.
5. ≥6 uses of cocaine by the smoked or IV route in the 12 months prior to Screening
6. Provide a positive urine drug screen (UDS) for cocaine at least once during the screening period or at admission. Repeat or rescheduled testing will be allowed at the investigator's discretion.
7. Have BP and Heart Rate (HR) within the following ranges after 5 minutes' rest at Screening and admission:
1. SBP: 90 to 139 mmHg, inclusive
2. DBP: 50 to 89 mmHg, inclusive
3. HR: 45 to 99 bpm, inclusive
8. If male, agree to use a double-barrier method (e.g., condom and spermicide) or agree to remain abstinent from heterosexual intercourse at the time of Screening, during the study, and for 90 days following the last administration of study drug. Male participants must agree not to donate sperm during the study and for 90 days following the last administration of study drug.
9. If female, meets one of the following criteria:
a. Physiological postmenopausal status, defined as the following: i. Absence of menses for at least 12 months prior to the first study drug administration (without an alternative medical condition); OR b. Surgically sterile (e.g., have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation/occlusion).
Exclusion Criteria:
1. Meet current Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for any SUDs other than cocaine, cannabis, or nicotine. Diagnosis of mild to moderate alcohol use disorder will not be considered exclusionary.
2. Have a DSM-5 psychiatric disorder other than SUD, including but not limited to, Bipolar Disorder, Major Depressive Disorder, or Schizophrenia, or have a neurological disorder requiring ongoing treatment and/or making study participation unsafe.
3. Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, paranoid reaction, or epileptic seizure.
4. Have a 12-lead ECG with repeated demonstration of corrected QT interval (QTcF) ≥470 msec in female participants or ≥450 msec in male participants at Screening.
5. Unable to tolerate a 20 mg cocaine IV infusion (Day -2) or a 40 mg cocaine IV infusion (Day -1) during the Baseline Phase, as judged by the investigator or designee and per criteria in protocol;
6. History or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, gastrointestinal, neurological, respiratory, or endocrine disorder, which would preclude safe or successful completion of the study, as determined by an investigator.
7. Have a history of any illness, or a family history of early significant cardiovascular disease that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the participant.
8. Have a significant risk of developing psychosis (assessed by Prevention through Risk Identification, Management, and Education \[PRIME\] screen) or have a personal history of psychotic symptoms (hallucinations or delusions), with or without a formal psychiatric diagnosis.
9. Have a family history of significant mental, behavioral, or neurodevelopmental disorders, unless determined by the investigator to be not clinically significant (NCS).
10. Have a current or past history of seizures, including alcohol- or stimulant-related seizures (excluding childhood febrile seizures), or significant family history of idiopathic seizure disorder or clinically significant (CS) head injury.
11. Have a diagnosis of adult (i.e., 21 years or older) asthma, or chronic obstructive pulmonary disease (COPD), including those with a history of acute asthma within the past two years, and those with current or recent (past 2 years) treatment with inhaled or oral beta-agonist.
12. Smoked \>40 cigarettes per day on average, in the month prior to Screening, or are unable to abstain from smoking (or use of any nicotine-containing substance) for at least 8 hours.
13. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by an investigator.
14. History of stomach or intestinal surgery, or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
15. Evidence of CS hepatic or renal impairment, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine \>1.5 × the upper limit of normal (ULN) at Screening or admission to the Baseline Phase. Retesting may be permitted at the discretion of an investigator.
16. Any clinically significant abnormalities in laboratory test results at Screening that would, in the opinion of an investigator, increase the participant's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data. Retesting may be permitted at the discretion of an investigator.
17. Are seropositive for hepatitis B surface antigen, hepatitis C antibody (asymptomatic hepatitis C virus infection at Screening is allowed), or human immunodeficiency virus (HIV).
18. Have significant current suicidal ideation or a history of suicide attempt within the past 12 months, as assessed by the C-SSRS (baseline version), or have significant current homicidal ideation.
19. If female, is currently pregnant (positive pregnancy test) or lactating, or who is planning to become pregnant within 30 days of last study drug administration.
20. Use of a prohibited medication or investigational drug, as specified in protocol.
21. Consumption of any foods or beverages that alter CYP1A2 activity (e.g., barbecued food or cruciferous vegetables, such as broccoli and cauliflower) or CYP3A4 activity (e.g., foods or beverages containing grapefruit or Seville-type oranges), within 7 days prior to admission to the Baseline Phase (a list of prohibited foods will be provided to participants).
22. Have received blood products within 2 months of admission to the Baseline Phase.
23. Positive UDS at admission to the Baseline Phase (Day -3), other than cocaine or tetrahydrocannabinol (THC). If THC is positive, a cannabis intoxication evaluation will be done by an investigator, and participants may be permitted to continue in the study at the discretion of an investigator. The UDS may be repeated and/or the participant may be rescheduled at the investigator's discretion.
24. Have donated or lost more than 500 mL whole blood within 56 days or have donated plasma within 7 days prior to Screening, or have participated in another clinical trial within the last 30 days prior to screening.
25. Have difficulty with venous access or are unsuitable or unwilling to undergo catheter insertion or direct venipuncture.
26. Currently on probation or have any pending legal action that could prohibit participation or compliance in the study.
27. Are an employee of the sponsor, a research site staff member directly affiliated with this study, or are an immediate family member, defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
28. Have any other condition that, in an investigator's opinion, (i) puts participant at increased risk, (ii) could confound the study results, (iii) may interfere significantly with participant's participation in the study, or (iv) have the potential to limit the participant's ability to complete the study .
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06648668
Study Brief:
Protocol Section:
NCT06648668