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

• ClinicalTrials.gov Identifier: NCT03301298
• Recruitment Status: Completed
• First Posted: October 4, 2017
• Results First Posted: September 26, 2019
• Last Update Posted: September 26, 2019
• Sponsor: Promentis Pharmaceuticals, Inc.
• Collaborator: Celerion
• Information provided by (Responsible Party): Promentis Pharmaceuticals, Inc.

Study Description

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; Drug: Placebo oral capsule	Phase 1

Study Design

• 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

Arm	Intervention/treatment
Experimental: SXC-2023, 50 mg; Single dose of 50 mg, given orally in capsule form.	Drug: SXC-2023; Oral capsule
Experimental: SXC-2023, 100 mg; Single dose of 100 mg, given orally in capsule form.	Drug: SXC-2023; Oral capsule
Experimental: SXC-2023, 200 mg; Single dose of 200mg, given orally in capsule form.	Drug: SXC-2023; Oral capsule
Experimental: SXC-2023, 400 mg; Single dose of 400mg, given orally in capsule form.	Drug: SXC-2023; Oral capsule
Experimental: SXC-2023, 800 mg; Single dose of 800mg, given orally in capsule form.	Drug: SXC-2023; Oral capsule
Experimental: SXC-2023, 1600 mg; Single dose of 1600 mg, given orally in capsule form.	Drug: SXC-2023; Oral capsule
Placebo Comparator: Placebo oral capsule; Placebo comparator, given once orally in matching capsule form.	Drug: Placebo oral capsule; Placebo given as oral capsule.

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects Experiencing TEAEs. [ Time Frame: 8 days ]
   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.

Secondary Outcome Measures :

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

• 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

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.

  Study Documents (Full-Text)

Documents provided by Promentis Pharmaceuticals, Inc.:

Statistical Analysis Plan  [PDF] February 28, 2018

Study Protocol  [PDF] January 5, 2018

More Information

• Responsible Party: Promentis Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03301298
• Other Study ID Numbers: PRO-101
• First Posted: October 4, 2017
• Results First Posted: September 26, 2019
• Last Update Posted: September 26, 2019
• Last Verified: August 2019

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