Clinical trial NCT03301298: Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Promentis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2017-10-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects Experiencing TEAEs.
timeFrame: 8 days
Secondary outcomes:
measure: Pharmacokinetic Assessments: Cmax
timeFrame: 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.
measure: Pharmacokinetics Assessments: Tmax
timeFrame: 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.
measure: Pharmacokinetic Assessments: AUC
timeFrame: 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.
measure: Pharmacokinetic: Food Effect, AUC
timeFrame: 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.
measure: Pharmacokinetic: Food Effect, CMax
timeFrame: 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.
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Promentis Pharmaceuticals, Inc.
name: Tricia Cotter
role: STUDY_DIRECTOR
References: