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
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: SXC-2023 Drug: Placebo oral capsule | Phase 1 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: SXC-2023, 50 mg
Single dose of 50 mg, given orally in capsule form.
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Drug: SXC-2023
Oral capsule |
Experimental: SXC-2023, 100 mg
Single dose of 100 mg, given orally in capsule form.
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Drug: SXC-2023
Oral capsule |
Experimental: SXC-2023, 200 mg
Single dose of 200mg, given orally in capsule form.
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Drug: SXC-2023
Oral capsule |
Experimental: SXC-2023, 400 mg
Single dose of 400mg, given orally in capsule form.
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Drug: SXC-2023
Oral capsule |
Experimental: SXC-2023, 800 mg
Single dose of 800mg, given orally in capsule form.
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Drug: SXC-2023
Oral capsule |
Experimental: SXC-2023, 1600 mg
Single dose of 1600 mg, given orally in capsule form.
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Drug: SXC-2023
Oral capsule |
Placebo Comparator: Placebo oral capsule
Placebo comparator, given once orally in matching capsule form.
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Drug: Placebo oral capsule
Placebo given as oral capsule. |
- 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.
- 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
- 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
- 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
- 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.
- 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.

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

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
United States, Arizona | |
Celerion | |
Tempe, Arizona, United States, 85283 |
Study Director: | Tricia Cotter | Promentis Pharmaceuticals, Inc. |
Documents provided by Promentis Pharmaceuticals, Inc.:
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |