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Trial registered on ANZCTR


Registration number
ACTRN12619000448145
Ethics application status
Approved
Date submitted
16/08/2018
Date registered
19/03/2019
Date last updated
19/03/2019
Date data sharing statement initially provided
19/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 295827 0
None
Universal Trial Number (UTN)
U1111-1176-1673
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Pain 309272 0
Condition category
Condition code
Anaesthesiology 308145 308145 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SP 102 consists of dexamethasone sodium phosphate equivalent to 10 mg dexamethasone in 2 mL of injectable gel administered by epidural injection. The washout period between treatments is 4 weeks.
Intervention code [1] 312160 0
Treatment: Drugs
Comparator / control treatment
Dexamethasone sodium phosphate injection, USP (10 mg dexamethasone) administered by intravenous (IV) injection.
Control group
Active

Outcomes
Primary outcome [1] 307118 0
SP-102 plasma bioavailability will be determined by comparing the PK parameters (Cmax and AUCinf) following Treatment 1 to the same parameters following Treatment 2.
Timepoint [1] 307118 0
8am (±10 mins) predose, and postdose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 20, 24, and 48 hours.
Secondary outcome [1] 350759 0
Safety and Tolerability of SP-102. Measured by physical examinations, vital signs, ECG, patient reported pain rating scale (NPRS), laboratory tests, collection and follow-up on all Adverse Events during the study.
Timepoint [1] 350759 0
Throughout study from pre-dose to End of study visit.
Secondary outcome [2] 368328 0
Pharmacodynamics of SP-102 as measured by cortisol levels and WBC.
Timepoint [2] 368328 0
Treatment 1: 8am (±10 mins) predose on T1-Day 1, then at 8am (±10 mins) on T1-Days 2, 3, 4, 8, 15, 22, and 28.
• Treatment 2: 8am (±10 mins) predose on T2-Day 1, then at 8am (±10 mins) on T2-Days 2, 3, 4, 8, 15, 22, and 28 (EOS).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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/breastfeeding, plan to breastfeed, or plan to become pregnant while participating in the study.
21. A history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of the Screening Visit.
22. The presence of any disorder, condition, laboratory abnormality, or circumstance (with the exception of the condition under study) as determined by a medical and psychiatric history, medical examination, ECG, serum chemistry, hematology, and urinalysis that, in the opinion of the investigator, has the potential to compromise subject safety, prevent study completion, and/or to have a confounding effect on outcome measures.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
Pharmacokinetic parameters will be derived using noncompartmental methods using validated PK software.
Dexamethasone and dexamethasone phosphate (SP-102 treatment only) plasma concentrations will be summarized by treatment using descriptive statistics (including N, mean, standard deviation [SD], %CV, median, minimum, and maximum) for each treatment. Concentrations below the limit of quantification (BLQ) will be treated as zero for the computation of descriptive statistics and for construction of mean concentration-time profiles. Concentrations assigned a value of missing will be omitted from the calculation of descriptive statistics.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/01/2016
Date of last participant enrolment
Anticipated
Actual
7/07/2016
Date of last data collection
Anticipated
Actual
30/08/2016
Sample size
Target
16
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 20783 0
New Zealand
State/province [1] 20783 0

Funding & Sponsors
Funding source category [1] 300423 0
Commercial sector/Industry
Name [1] 300423 0
Semnur Pharmaceuticals
Country [1] 300423 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Semnur Pharmceuticals
Address
Semnur Pharmaceuticals, Inc.
4970 El Camino Real Suite 205
Los Altos, CA 94022
Country
United States of America
Secondary sponsor category [1] 299883 0
None
Name [1] 299883 0
Address [1] 299883 0
Country [1] 299883 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301225 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 301225 0
Ethics committee country [1] 301225 0
New Zealand
Date submitted for ethics approval [1] 301225 0
05/11/2015
Approval date [1] 301225 0
08/12/2015
Ethics approval number [1] 301225 0
NZ/14/FD59015

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86294 0
Prof Richard Robson
Address 86294 0
Christchurch Clinical Studies
31 Tuam Street, Christchurch, 8011
Country 86294 0
New Zealand
Phone 86294 0
+6433729477
Fax 86294 0
Email 86294 0
richard@ccst.co.nz
Contact person for public queries
Name 86295 0
Josephine Harris
Address 86295 0
IQVIA Ltd
C/- Unit A, 2 Rothwell Avenue
Rosedale
Auckland 0632
New Zealand
Country 86295 0
New Zealand
Phone 86295 0
+642179687
Fax 86295 0
Email 86295 0
josephine.harris@quintiles.com
Contact person for scientific queries
Name 86296 0
Josephine Harris
Address 86296 0
IQVIA Ltd
C/- Unit A, 2 Rothwell Avenue
Rosedale
Auckland 0632
New Zealand
Country 86296 0
New Zealand
Phone 86296 0
+642179687
Fax 86296 0
Email 86296 0
josephine.harris@quintiles.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only group summarised data will be published, no individual participant data will be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe pharmacokinetics and pharmacodynamics of dexamethasone following epidural SP-102 or intravenous dexamethasone sodium phosphate injection in subjects with lumbosacral radicular pain.2022https://dx.doi.org/10.5414/CP204221
N.B. These documents automatically identified may not have been verified by the study sponsor.