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

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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:
Collaborator:
Celerion
Information provided by (Responsible Party):
Promentis Pharmaceuticals, Inc.

Study Description
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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
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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
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301298


Locations
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United States, Arizona
Celerion
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Promentis Pharmaceuticals, Inc.
Celerion
Investigators
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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
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Responsible Party: Promentis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03301298    
Other Study ID Numbers: PRO-101
First Posted: October 4, 2017    Key Record Dates
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

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