HealthyPhase 1NCT03301298
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
A Phase 1 study testing SXC-2023 in people with Healthy, run by Promentis Pharmaceuticals, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SXC-2023
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2017to 13 Feb 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- SXC-2023, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SXC-2023Drug
Oral capsule
Placebo oral capsuleDrug
Placebo given as oral capsule.
| Study group | Role | What they receive |
|---|---|---|
| SXC-2023, 50 mg | Experimental | Single dose of 50 mg, given orally in capsule form. Receives: Drug: SXC-2023 |
| SXC-2023, 100 mg | Experimental | Single dose of 100 mg, given orally in capsule form. Receives: Drug: SXC-2023 |
| SXC-2023, 200 mg | Experimental | Single dose of 200mg, given orally in capsule form. Receives: Drug: SXC-2023 |
| SXC-2023, 400 mg | Experimental | Single dose of 400mg, given orally in capsule form. Receives: Drug: SXC-2023 |
| SXC-2023, 800 mg | Experimental | Single dose of 800mg, given orally in capsule form. Receives: Drug: SXC-2023 |
| SXC-2023, 1600 mg | Experimental | Single dose of 1600 mg, given orally in capsule form. Receives: Drug: SXC-2023 |
| Placebo oral capsule | Placebo comparator | Placebo comparator, given once orally in matching capsule form. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Experiencing TEAEs.
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.
Measured: 8 days
Secondary outcomes (5)
Pharmacokinetic Assessments: Cmax
Peak plasma concentration
Measured: 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 to peak plasma concentration
Measured: 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
Area under the plasma concentration-time curve
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start11 Sep 2017
- Primary completion13 Feb 2018
- Study completion13 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promentis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Tricia Cotter, Study director, Promentis Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301298
- Sponsor's protocol ID
- PRO-101
- Status last verified
- Aug 2019
- First submitted
- 26 Sep 2017
- Last updated
- 26 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03301298
- Acronym / sponsor ID
- PRO-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Promentis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 13 Feb 2018 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Posted 26 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| SXC-2023, 50 mg | Experimental | Drug: SXC-2023Single dose of 50 mg, given orally in capsule form. |
| SXC-2023, 100 mg | Experimental | Drug: SXC-2023Single dose of 100 mg, given orally in capsule form. |
| SXC-2023, 200 mg | Experimental | Drug: SXC-2023Single dose of 200mg, given orally in capsule form. |
| SXC-2023, 400 mg | Experimental | Drug: SXC-2023Single dose of 400mg, given orally in capsule form. |
| SXC-2023, 800 mg | Experimental | Drug: SXC-2023Single dose of 800mg, given orally in capsule form. |
| SXC-2023, 1600 mg | Experimental | Drug: SXC-2023Single dose of 1600 mg, given orally in capsule form. |
| Placebo oral capsule | Placebo comparator | Drug: Placebo oral capsulePlacebo comparator, given once orally in matching capsule form. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SXC-2023Oral capsule | Drug | SXC-2023, 100 mg, SXC-2023, 1600 mg, SXC-2023, 200 mg, SXC-2023, 400 mg, SXC-2023, 50 mg, SXC-2023, 800 mg |
| Placebo oral capsulePlacebo given as oral capsule. | Drug | Placebo oral capsule |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tricia Cotter study director
Promentis Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SXC-2023 in people with Healthy, run by Promentis Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Experiencing TEAEs. (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.