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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: SXC-2023 or Placebo	Phase 1

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	48 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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
Actual Study Start Date :	September 11, 2017
Actual Primary Completion Date :	February 13, 2018
Actual Study Completion Date :	February 13, 2018

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: SXC-2023; Dose escalation	Drug: SXC-2023 or Placebo; Oral capsule
Placebo Comparator: Placebo; Dose escalation	Drug: SXC-2023 or Placebo; Oral capsule

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Treatment related adverse events [ Time Frame: 8 days ]
   Treatment related adverse events as a measure of safety and tolerability of SXC-2023

Secondary Outcome Measures :

1. Pharmacokinetic Assessments: Cmax [ Time Frame: 72 hours ]
   Peak plasma concentration
2. Pharmacokinetics Assessments: Tmax [ Time Frame: 72 hours ]
   Time to peak plasma concentration
3. Pharmacokinetic Assessments: AUC [ Time Frame: 72 hours ]
   Area under the plasma concentration-time curve
4. Pharmacokinetic: Food effect, AUC [ Time Frame: 72 hours ]
   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.
5. Pharmacokinetic: Food effect, CMax [ Time Frame: 72 hours ]
   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.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arizona
Celerion
Tempe, Arizona, United States, 85283

Sponsors and Collaborators

Promentis Pharmaceuticals, Inc.

Celerion

Investigators

Study Director:	Tricia Cotter	Promentis Pharmaceuticals, Inc.

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Promentis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT03301298 History of Changes
Other Study ID Numbers:	PRO-101
First Posted:	October 4, 2017
Last Update Posted:	March 16, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No