- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03301298
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
August 26, 2019 updated by: Promentis Pharmaceuticals, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85283
- Celerion
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SXC-2023, 50 mg
Single dose of 50 mg, given orally in capsule form.
|
Oral capsule
|
EXPERIMENTAL: SXC-2023, 100 mg
Single dose of 100 mg, given orally in capsule form.
|
Oral capsule
|
EXPERIMENTAL: SXC-2023, 200 mg
Single dose of 200mg, given orally in capsule form.
|
Oral capsule
|
EXPERIMENTAL: SXC-2023, 400 mg
Single dose of 400mg, given orally in capsule form.
|
Oral capsule
|
EXPERIMENTAL: SXC-2023, 800 mg
Single dose of 800mg, given orally in capsule form.
|
Oral capsule
|
EXPERIMENTAL: SXC-2023, 1600 mg
Single dose of 1600 mg, given orally in capsule form.
|
Oral capsule
|
PLACEBO_COMPARATOR: Placebo oral capsule
Placebo comparator, given once orally in matching capsule form.
|
Placebo given as oral capsule.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Tricia Cotter, Promentis Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 11, 2017
Primary Completion (ACTUAL)
February 13, 2018
Study Completion (ACTUAL)
February 13, 2018
Study Registration Dates
First Submitted
September 26, 2017
First Submitted That Met QC Criteria
September 28, 2017
First Posted (ACTUAL)
October 4, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 26, 2019
Last Update Submitted That Met QC Criteria
August 26, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- PRO-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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