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Completed

NCT Number: NCT03301298

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult male or females (women of non child bearing potential), 18-55 years of age (inclusive).
  • Medically healthy with no clinically significant screening results.
  • 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.
  • Continuous non-smoker, at least 3 months prior to first dose and throughout the study.
  • Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol

Exclusion criteria

  • Subject is mentally or legally incapacitated.
  • 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.
  • History or presence of alcoholism or drug abuse within the past 2 years
  • Female subject of childbearing potential.
  • Blood donation or significant blood loss within 56 days prior to first dose.
  • Plasma donation within 7 days prior to first dose.
  • Participation in another clinical trial within 30 days prior to first dose.

Treatment and study plan

SXC-2023

Drug

Oral capsule

Placebo oral capsule

Drug

Placebo given as oral capsule.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Promentis Pharmaceuticals, Inc.

Industry

Collaborators

  • Celerion

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 4, 2017
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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