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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food effect study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SXC-2023, 50 mg | Experimental | Single dose of 50 mg, given orally in capsule form. |
|
| SXC-2023, 100 mg | Experimental | Single dose of 100 mg, given orally in capsule form. |
|
| SXC-2023, 200 mg | Experimental | Single dose of 200mg, given orally in capsule form. |
|
| SXC-2023, 400 mg | Experimental | Single dose of 400mg, given orally in capsule form. |
|
| SXC-2023, 800 mg | Experimental | Single dose of 800mg, given orally in capsule form. |
|
| SXC-2023, 1600 mg | Experimental | Single dose of 1600 mg, given orally in capsule form. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SXC-2023 | Drug | Oral capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Experiencing TEAEs. | Treatment related adverse events as a measure of safety and tolerability of SXC-2023. Measured by patient reporting, assessment of vital signs and laboratory assessments. | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Assessments: Cmax | Peak plasma concentration | Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing. |
| Pharmacokinetics Assessments: Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tricia Cotter | Promentis Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SXC-2023, 50 mg | Single dose of 50 mg, given orally in capsule form. SXC-2023: Oral capsule |
| FG001 | SXC-2023, 100 mg | Single dose of 100 mg, given orally in capsule form. SXC-2023: Oral capsule |
| FG002 | SXC-2023, 200 mg | Single dose of 200mg, given orally in capsule form. SXC-2023: Oral capsule |
| FG003 | SXC-2023, 400 mg | Single dose of 400mg, given orally in capsule form. SXC-2023: Oral capsule |
| FG004 | SXC-2023, 800 mg | Single dose of 800mg, given orally in capsule form. SXC-2023: Oral capsule |
| FG005 | SXC-2023, 1600 mg | Single dose of 1600 mg, given orally in capsule form. SXC-2023: Oral capsule |
| FG006 | Placebo | Placebo comparator, given once orally in matching capsule form. Placebo oral capsule: Placebo given as oral capsule. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Unfed Conditions |
| |||||||||||||
| Fed Conditions |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SXC-2023, 50 mg | Single dose of 50 mg, given orally in capsule form. SXC-2023: Oral capsule |
| BG001 | SXC-2023, 100 mg | Single dose of 100 mg, given orally in capsule form. SXC-2023: Oral capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Subjects Experiencing TEAEs. | Treatment related adverse events as a measure of safety and tolerability of SXC-2023. Measured by patient reporting, assessment of vital signs and laboratory assessments. | Posted | Number | participants | 8 days |
|
Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
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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 | SXC-2023, 50 mg | Single dose of 50 mg, given orally in capsule form. SXC-2023: Oral capsule |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Photophobia | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dean Brostowin | Promentis Pharmaceuticals | 617-300-6172 | dbrostowin@promentispharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2018 | Dec 11, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 5, 2018 | Dec 11, 2018 | Prot_001.pdf |
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| Placebo oral capsule | Placebo Comparator | Placebo comparator, given once orally in matching capsule form. |
|
| Placebo oral capsule | Drug | Placebo given as oral capsule. |
|
Time to peak plasma concentration
| Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing. |
| Pharmacokinetic Assessments: AUC | Area under the plasma concentration-time curve | Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing. |
| Pharmacokinetic: Food Effect, AUC | To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total AUC will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect. | Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing. |
| Pharmacokinetic: Food Effect, CMax | To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total CMax will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect. | Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing. |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | SXC-2023, 200 mg | Single dose of 200mg, given orally in capsule form. SXC-2023: Oral capsule |
| BG003 | SXC-2023, 400 mg | Single dose of 400mg, given orally in capsule form. SXC-2023: Oral capsule |
| BG004 | SXC-2023, 800 mg | Single dose of 800mg, given orally in capsule form. SXC-2023: Oral capsule |
| BG005 | SXC-2023, 1600 mg | Single dose of 1600 mg, given orally in capsule form. SXC-2023: Oral capsule |
| BG006 | Placebo | Placebo comparator, given once orally in matching capsule form. Placebo oral capsule: Placebo given as oral capsule. |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
Single dose of 200mg, given orally in capsule form.
SXC-2023: Oral capsule
| OG003 | SXC-2023, 400 mg | Single dose of 400mg, given orally in capsule form. SXC-2023: Oral capsule |
| OG004 | SXC-2023, 800 mg | Single dose of 800mg, given orally in capsule form. SXC-2023: Oral capsule |
| OG005 | SXC-2023, 1600 mg | Single dose of 1600 mg, given orally in capsule form. SXC-2023: Oral capsule |
| OG006 | Placebo Oral Capsule | Placebo comparator, given once orally in matching capsule form. Placebo oral capsule: Placebo given as oral capsule. |
|
|
| Secondary | Pharmacokinetic Assessments: Cmax | Peak plasma concentration | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing. |
|
|
|
| Secondary | Pharmacokinetics Assessments: Tmax | Time to peak plasma concentration | Subject 1008 who received Treatment A in Cohort 1 did not have any measureable concentration of SXC-2023, NAC, or p-toluic acid and was excluded from the PK population. | Posted | Mean | Full Range | hours | Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing. |
|
|
|
| Secondary | Pharmacokinetic Assessments: AUC | Area under the plasma concentration-time curve | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing. |
|
|
|
| Secondary | Pharmacokinetic: Food Effect, AUC | To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total AUC will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect. | Cohort 5 participated in treatment under fasted conditions, followed by treatment under fed conditions. Other Cohorts did not participate. Subject 5004 received fasted treatment but discontinued prior to fed treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing. |
|
|
|
| Secondary | Pharmacokinetic: Food Effect, CMax | To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total CMax will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect. | Cohort 5 participated in treatment under fasted conditions, followed by treatment under fed conditions. Other Cohorts did not participate. Subject 5004 received fasted treatment but discontinued prior to fed treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing. |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | SXC-2023, 100 mg | Single dose of 100 mg, given orally in capsule form. SXC-2023: Oral capsule | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | SXC-2023, 200 mg | Single dose of 200mg, given orally in capsule form. SXC-2023: Oral capsule | 0 | 6 | 0 | 6 | 4 | 6 |
| EG003 | SXC-2023, 400 mg | Single dose of 400mg, given orally in capsule form. SXC-2023: Oral capsule | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | SXC-2023, 800 mg | Single dose of 800mg, given orally in capsule form. SXC-2023: Oral capsule | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | SXC-2023, 1600 mg | Single dose of 1600 mg, given orally in capsule form. SXC-2023: Oral capsule | 0 | 6 | 0 | 6 | 1 | 6 |
| EG006 | Placebo | Placebo comparator, given once orally in matching capsule form. Placebo oral capsule: Placebo given as oral capsule. | 0 | 12 | 0 | 12 | 4 | 12 |
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Feeling hot | General disorders | Non-systematic Assessment |
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| Thirst | General disorders | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Presyncope | Nervous system disorders | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Nervousness | Psychiatric disorders | Systematic Assessment |
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| Micturation urgency | Renal and urinary disorders | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
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| Polyuria | Renal and urinary disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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