Title
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
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
Phase
Phase 1Lead Sponsor
Promentis Pharmaceuticals, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
HealthyIntervention/Treatment
SXC-2023 ...Study Participants
48This 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.
Oral capsule
Placebo given as oral capsule.
Placebo comparator, given once orally in matching capsule form.
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.
| Event Type | Organ System | Event Term | SXC-2023, 50 mg | SXC-2023, 100 mg | SXC-2023, 200 mg | SXC-2023, 400 mg | SXC-2023, 800 mg | SXC-2023, 1600 mg | Placebo |
|---|
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.
Peak plasma concentration
Time to peak plasma concentration
Area under the plasma concentration-time curve
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.
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.
