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

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
SXC-2023, 50 mg	SXC-2023	Single dose of 50 mg, given orally in capsule form.
Placebo oral capsule	Placebo oral capsule	Placebo comparator, given once orally in matching capsule form.
SXC-2023, 100 mg	SXC-2023	Single dose of 100 mg, given orally in capsule form.
SXC-2023, 400 mg	SXC-2023	Single dose of 400mg, given orally in capsule form.
SXC-2023, 1600 mg	SXC-2023	Single dose of 1600 mg, given orally in capsule form.
SXC-2023, 200 mg	SXC-2023	Single dose of 200mg, given orally in capsule form.
SXC-2023, 800 mg	SXC-2023	Single dose of 800mg, given orally in capsule form.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Experiencing TEAEs.	8 days	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Assessments: Cmax	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.	Peak plasma concentration
Pharmacokinetics Assessments: Tmax	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.	Time to peak plasma concentration
Pharmacokinetic Assessments: AUC	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.	Area under the plasma concentration-time curve
Pharmacokinetic: Food Effect, AUC	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.	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.
Pharmacokinetic: Food Effect, CMax	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.	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.