Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Food Effect of SXC-2023 When Administered Orally to Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: SXC-2023
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male or females (women of non child bearing potential), 18-55 years of age (inclusive). Medically healthy with no clinically significant screening results. Non-vasectomized male subjects must agree to use birth control or abstain from sexual intercourse during and until 90 days beyond the last dose of study drug/placebo. Continuous non-smoker, at least 3 months prior to first dose and throughout the study. Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol Exclusion Criteria: Subject is mentally or legally incapacitated. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subjects by their participation in the study. History or presence of alcoholism or drug abuse within the past 2 years Female subject of childbearing potential. Blood donation or significant blood loss within 56 days prior to first dose. Plasma donation within 7 days prior to first dose. Participation in another clinical trial within 30 days prior to first dose.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SXC-2023, 50 mg<br>Single dose of 50 mg, given orally in capsule form. | Drug: SXC-2023<br>* Oral capsule<br>|
| Experimental: SXC-2023, 100 mg<br>Single dose of 100 mg, given orally in capsule form. | Drug: SXC-2023<br>* Oral capsule<br>|
| Experimental: SXC-2023, 200 mg<br>Single dose of 200mg, given orally in capsule form. | Drug: SXC-2023<br>* Oral capsule<br>|
| Experimental: SXC-2023, 400 mg<br>Single dose of 400mg, given orally in capsule form. | Drug: SXC-2023<br>* Oral capsule<br>|
| Experimental: SXC-2023, 800 mg<br>Single dose of 800mg, given orally in capsule form. | Drug: SXC-2023<br>* Oral capsule<br>|
| Experimental: SXC-2023, 1600 mg<br>Single dose of 1600 mg, given orally in capsule form. | Drug: SXC-2023<br>* Oral capsule<br>|
| Placebo Comparator: Placebo oral capsule<br>Placebo comparator, given once orally in matching capsule form. | Drug: Placebo oral capsule<br>* Placebo given as oral capsule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |