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Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
Phase 1 trial testing SXC-2023 in Healthy in 48 participants. Completed in 13 February 2018.
| Lead sponsor | Promentis Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 11 September 2017 |
| Primary completion | 13 February 2018 |
| Estimated completion | 13 February 2018 |
| Sites | 1 location across United States |
Promentis Pharmaceuticals, Inc. — full company profile →
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| SXC-2023, 50 mg | 3 | |
| SXC-2023, 100 mg | 0 | |
| SXC-2023, 200 mg | 4 | |
| SXC-2023, 400 mg | 1 | |
| SXC-2023, 800 mg | 2 | |
| SXC-2023, 1600 mg | 1 | |
| Placebo Oral Capsule | 4 |
Peak plasma concentration
| Group | Value | 95% CI |
|---|---|---|
| SXC-2023, 50 mg | 758.2 | ± 157.3 |
| SXC-2023, 100 mg | 2181 | ± 58.3 |
| SXC-2023, 200 mg | 5145 | ± 38.1 |
| SXC-2023, 400 mg | 9005 | ± 60.4 |
| SXC-2023, 800 mg | 25510 | ± 49.5 |
| SXC-2023, 1600 mg | 33700 | ± 35 |
Time to peak plasma concentration
| Group | Value | 95% CI |
|---|---|---|
| SXC-2023, 50 mg | 3.111 | 3.01 – 4.02 |
| SXC-2023, 100 mg | 3.016 | 2.01 – 6 |
| SXC-2023, 200 mg | 4 | 2 – 6 |
| SXC-2023, 400 mg | 4 | 2 – 4.01 |
| SXC-2023, 800 mg | 2.501 | 1.5 – 6 |
| SXC-2023, 1600 mg | 3.5 | 2 – 4 |
Area under the plasma concentration-time curve
| Group | Value | 95% CI |
|---|---|---|
| SXC-2023, 50 mg | 3213 | ± 154.1 |
| SXC-2023, 100 mg | 9732 | ± 73.9 |
| SXC-2023, 200 mg | 25180 | ± 43.2 |
| SXC-2023, 400 mg | 57170 | ± 54 |
| SXC-2023, 800 mg | 139500 | ± 28.6 |
| SXC-2023, 1600 mg | 239700 | ± 29.8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| SXC-2023, 800 mg Fed | 158700 | ± 31.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| SXC-2023, 800 mg Fed | 17160 | ± 26.3 |
Time frame: Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | SXC-2023, 50 mg | SXC-2023, 100 mg | SXC-2023, 200 mg | SXC-2023, 400 mg | SXC-2023, 800 mg | SXC-2023, 1600 mg | Placebo |
|---|---|---|---|---|---|---|---|---|
| Headache | Nervous system disorders | — | — | — | — | — | — | — |
| Photophobia | Eye disorders | — | — | — | — | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Dysphagia | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Mouth ulceration | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Feeling hot | General disorders | — | — | — | — | — | — | — |
| Thirst | General disorders | — | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — | — | — |
| Dizziness postural | Nervous system disorders | — | — | — | — | — | — | — |
| Presyncope | Nervous system disorders | — | — | — | — | — | — | — |
| Somnolence | Nervous system disorders | — | — | — | — | — | — | — |
| Tremor | Nervous system disorders | — | — | — | — | — | — | — |
| Nervousness | Psychiatric disorders | — | — | — | — | — | — | — |
| Micturation urgency | Renal and urinary disorders | — | — | — | — | — | — | — |
| Pollakiuria | Renal and urinary disorders | — | — | — | — | — | — | — |
| Polyuria | Renal and urinary disorders | — | — | — | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — |
| Pruritis | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — |
| Rash papular | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — |
Data from ClinicalTrials.gov NCT03301298 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03301298.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing