ACTRN12619000448145CompletedPhase 1
An Open-label, Single-arm, Two-period, Fixed Sequential-dose Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of SP 102 (Dexamethasone Sodium Phosphate Injectable Gel) Administered by Epidural Injection Compared with Dexamethasone Sodium Phosphate Injection, Administered by Intravenous Injection in Subjects with Lumbosacral Radiculopathy
Semnur Pharmceuticals0 sites16 target enrollmentStarted: March 19, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 16
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (—)
- Sex
- All
Inclusion Criteria
- •1.Able and willing to provide written informed consent prior to beginning any study procedures.
- •2.Age 18 to 70 years (inclusive) at the Screening Visit.
- •3.A diagnosis of lumbar or lumbosacral radicular pain at the Screening Visit. Pain must radiate unilaterally or bilaterally into the leg(s) in a dermatomal distribution, consistent with the diagnosis of lumbosacral radicular pain in the suspected involved nerve root(s).
- •4.The duration of the current episode of radicular pain must be at least 2 months, based on history and available medical records at the time of the Screening Visit.
- •5.If female, subjects of childbearing potential (i.e., not surgically sterile or 2 years postmenopausal) must have a negative pregnancy test at the Screening and Baseline Visits and agree to use a medically accepted method of contraception for the duration of the study.
- •6.A negative qualitative urine screen for drugs of abuse, including cocaine, marijuana, amphetamines, and barbiturates at the Screening and Baseline Visit;
- •7.The subject must agree not to take foods, drugs, and substances that are known to affect the activity of cytochrome P450 3A4 (CYP3A4) during the study.
- •8.Agrees to comply with all study requirements throughout the entire study period.
- •9.Screening Visit values for specific PD parameters (cortisol, WBC count, and glucose levels) are within specified normal ranges.
Exclusion Criteria
- •EXCLUSION CRITERIA
- •1.Body mass index (BMI) greater than or equal to 40 kg/m2 at the Screening Visit.
- •2.Insulin-dependent diabetes mellitus at the Screening or Baseline Visit.
- •3.Any active clinically significant uncontrolled, treated or untreated, medical condition (e.g., fungal, bacterial, or viral infections, cardiovascular disease, or renal and/or hepatic disease) at the Screening or Baseline Visit that would preclude the use of dexamethasone in this study.
- •4.Has a major psychiatric disorder not controlled with medication at the Screening or Baseline Visit that would interfere with clinical pain scores or participation in the trial.
- •5.History of any disorder related to cortisol production (e.g., hyper- or hypo-cortisolism, Cushing’s syndrome, pituitary tumor, Addison’s disease, Nelson syndrome) at the Screening or Baseline Visit.
- •6.History of malignancy or evidence of malignancy or lymphoproliferative or neoplastic disease with the exception of successfully treated basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia within 5 years of the Screening Visit.
- •7.History of allergy to corticosteroids or anaphylactoid reaction to any other drug at the Screening or Baseline Visit.
- •8.Known allergy or idiosyncratic (atopic) reaction to contrast agent, local anesthetic, dexamethasone, any ingredient listed as being present in a study formulation, or any other pain management compound likely to be prescribed in the study.
- •9.Use of anticoagulants such as roviraxaban, apixiban, coumadin, or heparin in the 7 days prior to the Baseline Visit.
- •10.Clinically significant abnormalities in clinical chemistry, hematology or urinalysis, including serum glutamic-oxaloacetic transaminase/aspartate aminotransferase (AST) or serum glutamic-pyruvic transaminase/alanine aminotransferase (ALT) greater than or equal to 3 times the upper limit of the reference range at the Screening Visit.
- •11.Creatinine clearance (CLcr) < 60 mL/min as estimated by Cockcroft-Gault equation at the Screening Visit.
- •12.Serology positive for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV) antibodies at the Screening Visit.
- •13.Significant pain unrelated to nerve root impingement at the Screening Visit or Baseline Visit that would significantly compromise assessment of the radicular back and leg pain related to the disk herniation.
- •14.Chronic use (i.e., more than 5 consecutive days) of oral or parenteral steroid medication during the 2 months prior to the Screening Visit and any oral or parenteral steroid medication in the 2 weeks prior to the Screening Visit or to the Baseline Visit.
- •15.Opioid use greater than an average of 30 mg morphine equivalents per day in the 2 weeks prior to the Baseline Visit.
- •16.An epidural steroid injection for the treatment of the current episode of lumbosacral radicular pain during the 2 months prior to the Screening Visit.
- •17.History of spine surgery prior to the Screening or Baseline Visit, which may interfere with inter-laminar epidural injection, or plans to undergo spine surgical intervention while in the study.
- •18.Has donated blood exceeding 500 mL during the 45 days before Baseline Visit.
- •19.Use of any investigational drug or device within 30 days prior to the Screening Visit, or is scheduled to receive an investigational drug other than blinded study drug during the course of this study.
- •20.If female, are lactating/brea
Investigators
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