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| ID | Type | Description | Link |
|---|---|---|---|
| U01DA051077 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Sanford Burnham Prebys | OTHER |
| University of California, San Diego | OTHER |
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This is a single center, first-in-human, randomized, double-blind, placebo-controlled, Single-Ascending Dose (SAD) / Multiple-Ascending Dose (MAD) study incorporating a food-effect cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A1 - Single-Dose (Active; 150 mg ) | Experimental | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects were randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
|
| Part A3 - Single-Dose Food Effect (Active; 225 mg) | Experimental | In this two-period food-effect cohort, each healthy nonsmoker subject received the randomly assigned treatment (SBP-9330 or placebo) under fasting conditions (Period 1). After a 7- to 14-day washout period, subjects received the same single dose of SBP-9330 or placebo in a fed state (Period 2) 30 minutes after the start of an FDA High-Fat and High-Calorie Breakfast. A sentinel group of 2 subjects were randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
|
| Part A2 - Single-Dose (Active; 300 mg) | Experimental | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects were randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
|
| Part A4 - Single-Dose (Active; 450 mg) | Experimental | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects were randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBP-9330 | Drug | SBP-9330 oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of drug-related adverse events as determined by clinically significant changes in vital signs, physical examination findings, ECG parameters, C-SSRS questionnaire results, and clinical laboratory results | Part A: 8 days Part B: 21 days Part C: 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of SBP-9330: Cmax | Maximum observed concentration (Cmax) | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Pharmacokinetics of SBP-9330: Tmax |
| Measure | Description | Time Frame |
|---|---|---|
| Expired Carbon Monoxide (ECO) Level | Expired breath CO was measured with a Bedfont Smokerlyzerâ„¢ | Daily from Screening through Day 14 |
| Plasma Cotinine Level | Blood samples were collected to measure plasma cotinine levels |
Inclusion Criteria:
Provision of written informed consent prior to the initiation of any protocol-specific procedures
Stated willingness to comply with all study procedures and availability for the duration of the study
Healthy male or female subject ≥ 18 and ≤ 55 years of age
Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 32.0 kg/m2
Body weight ≥ 50.0 kg at Screening
A female subject must meet at least one of the following criteria: a. Is of childbearing potential and agrees to use an acceptable contraceptive method. b. Is of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a postmenopausal state (i.e., at least 1 year without menses prior to the first study drug administration without an alternative medical condition and confirmed with a serum follicle-stimulating hormone [FSH] > 40 IU/L at Screening)
Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from the first admission to the CRU until 90 days after the last study drug administration.
Part A and B only: Never- or nonsmoker (a nonsmoker is defined as someone who completely stopped using nicotine products for at least 2 years prior to the first study drug administration)
Have no clinically significant medical or mental health conditions captured in the medical history or evidence of clinically significant findings on the physical examination and/or ECG, as determined by an Investigator
No clinically significant abnormalities in blood pressure, heart rate, body temperature and respiratory rate and no evidence of orthostatic hypotension or postural tachycardia at Screening.
Part C Only:
Are current tobacco cigarette smokers who smoke an average of 10 or more cigarettes per day in the 30 days prior to Screening
Expired breath CO level ≥10 parts per million (ppm) at Screening and prior to the first study drug administration
Positive test result for cotinine at Screening and prior to the first study drug administration
Are not motivated to try to quit smoking from Screening through 30 days from the first study drug administration
Exclusion Criteria:
Female who is lactating
Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration
Female who is planning to become pregnant during this study or within 90 days after the last study drug administration
Male with female partner who is pregnant, lactating, or planning to become pregnant during this study or within 90 days after the last study drug administration
Poor venous access as determined by an Investigator at Screening
History of significant hypersensitivity to SBP-9330 or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
Presence of any medical condition that, in the opinion of an Investigator, poses an unacceptable risk to the subjects
Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug absorption
Evidence or history of clinically significant cardiovascular, pulmonary, hematologic, psychiatric (including mood and substance use disorders), neurological (including migraines, seizures, and epilepsy), endocrine, renal, hepatic, gastrointestinal, immunologic or dermatologic disease
History of malignancy within the past five years, except for successfully treated basal cell carcinoma of the skin
History of suicidal ideation or suicidal behavior as per the C-SSRS questionnaire administered at Screening
Evidence or history of significant psychiatric disease or any DSM-5 disorder as assessed by the Mini International Neuropsychiatric Interview (M.I.N.I.) administered at Screening
Routine or chronic use of more than three grams of acetaminophen daily
Strenuous activity, sunbathing, and contact sports within 48 hours prior to (first) admission to the CRU
Current alcohol consumption exceeding two standard drinks per day on average (1 standard drink=10 grams of alcohol) for male subjects and one standard drink per day on average for female subjects
History of alcohol or drug (other than caffeine) use disorder within 12 months prior to Screening
Any clinically significant illness in the 28 days prior to the first study drug administration
QTcF interval (QT interval corrected for heart rate according to Fridericia) > 450 ms for males and > 470 ms for females at Screening or on Day -1
Parts A and B only: Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first drug administration
Positive test results for HIV-1/HIV-2 antibodies, hepatitis B surface antigen or hepatitis C antibody
Consumption of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) or over-the-counter medications and nutrients known to modulate cytochrome P450 (CYP450) enzymes activity (e.g., grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville [blood] orange products) or St. John's Wort within 14 days prior to the first study drug administration
Consumption of other prescription and over-the-counter medication not specifically excluded by Exclusion Criterion 21 including health supplements and herbal remedies within 7 days prior to the first study drug administration (an exception is made for paracetamol [acetaminophen], which is allowed up to admission to the clinic).
Any other clinically significant abnormalities in laboratory test results at Screening that would, in the opinion of an Investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data
Intake of an investigational product in the 30 days or 5 half-lives (whichever is longer) prior to Screening
Inclusion in a previous cohort of this clinical study
Employee of the contract research organization (CRO) or the Sponsor.
Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening
Plasma donation within 7 days prior to Screening
Part C Only:
History of generalized rash reaction to any drugs
Positive test result (except cotinine) for alcohol and/or drugs of abuse at Screening or prior to the first study drug administration
Use of smoking cessation aids (NRT, bupropion, or varenicline) within 30 days prior to the first study drug administration
Unable to abstain from smoking tobacco cigarettes for at least 1 hour before and 2 hours after study drug administration
Unable to abstain from using nicotine-containing products other than tobacco cigarettes (e.g., pipes, cigars, e-cigarettes or vapes, nicotine topical patches, nicotine gum, or nicotine lozenges) during the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Kansas, Inc | Overland Park | Kansas | 66212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A1 Single Dose (Active; 150 mg) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
| FG001 | Part A3 - Single-Dose Food-Effect (Active; 225 mg) | In this two-period food-effect cohort, each healthy nonsmoker subject received the randomly assigned treatment (SBP-9330 or placebo) under fasting conditions (Period 1). After a 7- to 14-day washout period, subjects received the same single dose of SBP-9330 or placebo in a fed state (Period 2) 30 minutes after the start of an FDA High-Fat and High-Calorie Breakfast. A sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
| FG002 | Part A2 - Single-Dose (Active; 300 mg) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
| FG003 | Part A4 - Single-Dose (Active; 450 mg) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
| FG004 | Part A5 - Single-Dose (Active; 600 mg) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
| FG005 | Part A - Single Dose - Placebo (Pooled) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
| FG006 | Part B1 - Multiple-Dose (Active; 150 mg) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
| FG007 | Part B2 - Multiple-Dose (Active; 225 mg) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
| FG008 | Part B3 - Multiple-Dose (Active; 300 mg) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
| FG009 | Part B - Multiple-Dose Placebo (Pooled) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
| FG010 | Part C1 - Smoker Phase (Active; 150 mg) | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
| FG011 | Part C2 - Smoker Phase (Active; 225 mg) | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
| FG012 | Part C - Smoker Phase Placebo (Pooled) | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A1 - Single-Dose (Active; 150 mg ) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. SBP-9330: SBP-9330 oral capsules |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of drug-related adverse events as determined by clinically significant changes in vital signs, physical examination findings, ECG parameters, C-SSRS questionnaire results, and clinical laboratory results | Posted | Count of Participants | Participants | Part A: 8 days Part B: 21 days Part C: 21 days |
|
Part A: 8 days Part B: 21 days Part C: 21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A1 Single Dose (Active; 150 mg) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gonul Velicelebi | Camino Pharma | 858-201-2901 | gonul@caminopharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 14, 2022 | Feb 17, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2023 | Feb 17, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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|
| Part A5 - Single-Dose (Active; 600 mg) | Experimental | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects were randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
|
| Part A - Single-Dose (Placebo; pooled) | Placebo Comparator | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects were randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
|
| Part B1 - Multiple-Dose Active (150 mg) | Experimental | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
|
| Part B2 - Multiple-Dose Active (225 mg) | Experimental | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
|
| Part B3 - Multiple-Dose Active (300 mg) | Experimental | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
|
| Part B - Multiple-Dose Placebo (pooled) | Placebo Comparator | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
|
| Part C1 - Smoker Phase (Active; 150 mg) | Experimental | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
|
| Part C2 - Smoker Phase (Active; 225 mg) | Experimental | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
|
| Part C - Smoker Phase (Placebo; pooled) | Placebo Comparator | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
|
| Placebo | Drug | Placebo oral capsules |
|
Time to reach maximum observed concentration (Tmax)
| PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Pharmacokinetics of SBP-9330: AUC 0-24 | Area under the concentration time curve from time 0 (dose administration) to 24 hours | PK samples were obtained at selected timepoints from pre-dose until 24 hours post-dose |
| Pharmacokinetics of SBP-9330: AUC 0-T | Area under the concentration time curve from time 0 (dose administration) to the time of last quantifiable concentration | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Pharmacokinetics of SBP-9330: AUC 0-∞ | Area under the concentration time curve extrapolated to infinity | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Pharmacokinetics of SBP-9330: T½ | Terminal elimination half-life | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Pharmacokinetics of SBP-9330: CL/F | Apparent total clearance | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Pharmacokinetics of SBP-9330: Vz/F | Apparent volume of distribution | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Pharmacokinetics of SBP-9330: C Trough | Observed concentration at the end of the dosing interval | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Pharmacokinetics of SBP-9330: CÏ„ | Concentration at the end of the dosing interval. | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Pharmacokinetics of SBP-9330: AUCÏ„ | Area under the concentration time curve over the dosing interval at steady state, calculated from 0 to 24 hours (dosing interval) | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Pharmacokinetics of SBP-9330: T½, Eff | Effective half-life | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Pharmacokinetics of SBP-9330: CL/Fss | Apparent total clearance at steady state | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Pharmacokinetics of SBP-9330: Vz/Fss | Apparent volume of distribution at steady state | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Pharmacokinetics of SBP-9330: RAC(Cmax) | Accumulation ratio evaluated by comparing Day 14 Cmax to Day 1 Cmax | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Pharmacokinetics of SBP-9330: RAC(AUC) | Accumulation ratio evaluated by comparing Day 14 AUCÏ„ to Day 1 AUC0-24 | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose |
| Predose, Day 7 and Day 14 |
| Number of Cigarettes Smoked | A daily smoking log was kept to document the number of cigarettes smoked | Daily from Screening through Day 14 |
| Minnesota Nicotine Withdrawal Scale (MNWS) | A self-report measure used to monitor symptoms of tobacco withdrawal. | Screening through Day 14 |
| Questionnaire on Smoking Urges - Brief Version (QSU-Brief) | A self-report questionnaire used to measure cravings to smoke. | Screening through Day 15 |
| BG001 | Part A2 - Single-Dose Food-Effect (Active; 225 mg) | In this two-period food-effect cohort, each healthy nonsmoker subject received the randomly assigned treatment (SBP-9330 or placebo) under fasting conditions (Period 1). After a 7- to 14-day washout period, subjects received the same single dose of SBP-9330 or placebo in a fed state (Period 2) 30 minutes after the start of an FDA High-Fat and High-Calorie Breakfast. A sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. SBP-9330: SBP-9330 oral capsules |
| BG002 | Part A3 - Single-Dose (Active; 300 mg) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. SBP-9330: SBP-9330 oral capsules |
| BG003 | Part A4 - Single-Dose (Active; 450 mg) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. SBP-9330: SBP-9330 oral capsules |
| BG004 | Part A5 - Single-Dose (Active; 600 mg) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. SBP-9330: SBP-9330 oral capsules |
| BG005 | Part A - Single Dose - Placebo (Pooled) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. Placebo: Placebo oral capsules |
| BG006 | Part B1 - Multiple-Dose (Active; 150 mg) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. SBP-9330: SBP-9330 oral capsules |
| BG007 | Part B2 - Multiple-Dose (Active; 225 mg) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. SBP-9330: SBP-9330 oral capsules |
| BG008 | Part B3 - Multiple-Dose (Active; 300 mg) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. SBP-9330: SBP-9330 oral capsules |
| BG009 | Part B - Multiple-Dose Placebo (Pooled) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. Placebo: Placebo oral capsules |
| BG010 | Part C1 - Smoker Phase (Active; 150 mg) | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. SBP-9330: SBP-9330 oral capsules |
| BG011 | Part C2 - Smoker Phase (Active; 225 mg) | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. SBP-9330: SBP-9330 oral capsules |
| BG012 | Part C - Smoker Phase Placebo (Pooled) | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. Placebo: Placebo oral capsules |
| BG013 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
In this two-period food-effect cohort, each healthy nonsmoker subject received the randomly assigned treatment (SBP-9330 or placebo) under fasting conditions (Period 1). After a 7- to 14-day washout period, subjects received the same single dose of SBP-9330 or placebo in a fed state (Period 2) 30 minutes after the start of an FDA High-Fat and High-Calorie Breakfast. A sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
| OG002 | Part A3 - Single-Dose (Active; 300 mg) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
| OG003 | Part A4 - Single-Dose (Active; 450 mg) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
| OG004 | Part A5 - Single-Dose (Active; 600 mg) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
| OG005 | Part A - Single Dose - Placebo (Pooled) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. |
| OG006 | Part B1 - Multiple-Dose (Active; 150 mg) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
| OG007 | Active Comparator: Part B2 - Multiple-Dose (Active; 225 mg) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
| OG008 | Active Comparator: Part B3 - Multiple-Dose (Active; 300 mg) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
| OG009 | Part B - Multiple-Dose Placebo (Pooled) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
| OG010 | Part C1 - Smoker Phase (Active; 150 mg) | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
| OG011 | Part C2 - Smoker Phase (Active; 225 mg) | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
| OG012 | Part C - Smoker Phase Placebo (Pooled) | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. |
|
|
| Secondary | Pharmacokinetics of SBP-9330: Cmax | Maximum observed concentration (Cmax) | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: Tmax | Time to reach maximum observed concentration (Tmax) | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: AUC 0-24 | Area under the concentration time curve from time 0 (dose administration) to 24 hours | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 24 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: AUC 0-T | Area under the concentration time curve from time 0 (dose administration) to the time of last quantifiable concentration | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: AUC 0-∞ | Area under the concentration time curve extrapolated to infinity | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: T½ | Terminal elimination half-life | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: CL/F | Apparent total clearance | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: Vz/F | Apparent volume of distribution | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: C Trough | Observed concentration at the end of the dosing interval | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: CÏ„ | Concentration at the end of the dosing interval. | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: AUCÏ„ | Area under the concentration time curve over the dosing interval at steady state, calculated from 0 to 24 hours (dosing interval) | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: T½, Eff | Effective half-life | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: CL/Fss | Apparent total clearance at steady state | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: Vz/Fss | Apparent volume of distribution at steady state | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: RAC(Cmax) | Accumulation ratio evaluated by comparing Day 14 Cmax to Day 1 Cmax | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Secondary | Pharmacokinetics of SBP-9330: RAC(AUC) | Accumulation ratio evaluated by comparing Day 14 AUCÏ„ to Day 1 AUC0-24 | Not Posted | PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose | Participants |
| Other Pre-specified | Expired Carbon Monoxide (ECO) Level | Expired breath CO was measured with a Bedfont Smokerlyzerâ„¢ | Not Posted | Daily from Screening through Day 14 | Participants |
| Other Pre-specified | Plasma Cotinine Level | Blood samples were collected to measure plasma cotinine levels | Not Posted | Predose, Day 7 and Day 14 | Participants |
| Other Pre-specified | Number of Cigarettes Smoked | A daily smoking log was kept to document the number of cigarettes smoked | Not Posted | Daily from Screening through Day 14 | Participants |
| Other Pre-specified | Minnesota Nicotine Withdrawal Scale (MNWS) | A self-report measure used to monitor symptoms of tobacco withdrawal. | Not Posted | Screening through Day 14 | Participants |
| Other Pre-specified | Questionnaire on Smoking Urges - Brief Version (QSU-Brief) | A self-report questionnaire used to measure cravings to smoke. | Not Posted | Screening through Day 15 | Participants |
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Part A3 - Single-Dose Food-Effect (Active; 225 mg) | In this two-period food-effect cohort, each healthy nonsmoker subject received the randomly assigned treatment (SBP-9330 or placebo) under fasting conditions (Period 1). After a 7- to 14-day washout period, subjects received the same single dose of SBP-9330 or placebo in a fed state (Period 2) 30 minutes after the start of an FDA High-Fat and High-Calorie Breakfast. A sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | Part A2 - Single-Dose (Active; 300 mg) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data will be completed prior to administration of doses to the remainder of the cohort. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | Part A4 - Single-Dose (Active; 450 mg) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data will be completed prior to administration of doses to the remainder of the cohort. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | Part A5 - Single-Dose (Active; 600 mg) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data will be completed prior to administration of doses to the remainder of the cohort. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG005 | Part A - Single Dose - Placebo (Pooled) | In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data will be completed prior to administration of doses to the remainder of the cohort. | 0 | 10 | 0 | 10 | 3 | 10 |
| EG006 | Part B1 - Multiple-Dose (Active; 150 mg) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG007 | Active Comparator: Part B3 - Multiple-Dose (Active; 225 mg) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG008 | Active Comparator: Part B2 - Multiple-Dose (Active; 300 mg) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG009 | Part B - Multiple-Dose Placebo (Pooled) | In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG010 | Part C1 - Smoker Phase (Active; 150 mg) | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG011 | Part C2 - Smoker Phase (Active; 225 mg) | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG012 | Part C - Smoker Phase Placebo (Pooled) | In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts. | 0 | 4 | 0 | 4 | 1 | 4 |
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
| Presyncope | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal distention | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Orthostatic heart rate response increased | Investigations | Systematic Assessment |
|
| White blood cell count decreased | Investigations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Chest discomfort | General disorders | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hypochloraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | Systematic Assessment |
|
| Vaginal hemorrhage | Reproductive system and breast disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | Systematic Assessment |
|
| Ingrown hair | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Paresthesia oral | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided