Phase 1
Completed N=48
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT03301298 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Number of Subjects Experiencing TEAEs. — 3; 0; 4; 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Experiencing TEAEs. |
3; 0; 4; 1; 2; 1 | — |
| SECONDARY Pharmacokinetic Assessments: Cmax |
758.2; 2181; 5145; 9005; 25510; 33700 | — |
| SECONDARY Pharmacokinetics Assessments: Tmax |
3.111; 3.016; 4; 4; 2.501; 3.5 | — |
| SECONDARY Pharmacokinetic Assessments: AUC |
3213; 9732; 25180; 57170; 139500; 239700 | — |
| SECONDARY Pharmacokinetic: Food Effect, AUC |
158700 | — |
| SECONDARY Pharmacokinetic: Food Effect, CMax |
17160 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03301298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.