Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 4/17/2018 |
Start Date: | September 11, 2017 |
End Date: | February 13, 2018 |
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
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.
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.
Inclusion Criteria:
1. Healthy adult male or females (women of non child bearing potential), 18-55 years of
age (inclusive).
2. Medically healthy with no clinically significant screening results.
3. 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.
4. Continuous non-smoker, at least 3 months prior to first dose and throughout the study.
5. Understands the study procedures in the informed consent form, and be willing and able
to comply with the protocol
Exclusion Criteria:
1. Subject is mentally or legally incapacitated.
2. 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.
3. History or presence of alcoholism or drug abuse within the past 2 years
4. Female subject of childbearing potential.
5. Blood donation or significant blood loss within 56 days prior to first dose.
6. Plasma donation within 7 days prior to first dose.
7. Participation in another clinical trial within 30 days prior to first dose.
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