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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05029518




Registration number
NCT05029518
Ethics application status
Date submitted
22/08/2021
Date registered
31/08/2021
Date last updated
11/03/2022

Titles & IDs
Public title
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
Scientific title
A Phase 1, Randomized, Open-Label, Single-Dose, 3-Way Crossover Study to Compare the PK of Two Oral Formulations of SMP-100 and to Evaluate the Effect of Food on the Bioavailability of SMP-100 Tablets in Normal Healthy Volunteers
Secondary ID [1] 0 0
SciMount
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SMP-100

Experimental: Treatment A: SMP-100 dissolved in water administered under fasting conditions - 12 subjects,For Treatment A, SMP-100 will be dissolved in a total of 240 mL of water and administered orally to each subjects, and a hand and mouth check will be performed to ensure consumption of the medication. Subjects will be required not to wear dentures or mouth piercing at the time of dosing. No food will be allowed from at least 10 hours before dosing until at least 4 hours post-dose.

Experimental: Treatment B: SMP-100 tablets administered under fasting conditions - 12 subjects,For Treatment B, SMP-100 tablets will be administered to each subject with 240 mL of water and a hand and mouth check will be performed to ensure consumption of the medication. The dosing procedure must be completed within 2 minutes. In the event that subjects cannot swallow all tablets with 240 mL of water, additional water may be allowed up to a maximum total volume of 400 mL. No food will be allowed from at least 10 hours before dosing until at least 4 hours post-dose.

Experimental: Treatment C: SMP-100 tablets administered under fed conditions - 12 subjects,For Treatment C, SMP-100 tablets will be administered to each subject with 240 mL of water and a hand and mouth check will be performed to ensure consumption of the medication. The dosing procedure must be completed within 2 minutes. In the event that subjects cannot swallow all tablets with 240 mL of water, additional water may be allowed up to a maximum total volume of 400 mL.

After a supervised fast of at least 10 hours, subjects will be served a high-fat, high-calorie meal of approximately 800 to 1000 calories (approximately 50% of total caloric content of the meal derived from fat). This test meal should derive approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively. Subjects should start the meal approximately 30 minutes prior to drug administration. Subjects will be required to completely eat the meal in 30 minutes or less. No food will be allowed until at least 4 hours post-dose.


Treatment: Drugs: SMP-100
In each period, subjects will receive a single dose of SMP-100 on Day 1 (Period 1), Day 4 (Period 2), and Day 7 (Period 3), under fasting or fed conditions, followed by 48 hours of PK and safety assessments.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary PK endpoints: AUC( 0-inf)
Timepoint [1] 0 0
pre-dose and 0.25, 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, and 48 hours post-dose
Primary outcome [2] 0 0
Primary PK endpoint: AUC(0-t)
Timepoint [2] 0 0
pre-dose and 0.25, 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, and 48 hours post-dose
Primary outcome [3] 0 0
Primary PK endpoint: Cmax
Timepoint [3] 0 0
pre-dose and 0.25, 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, and 48 hours post-dose
Secondary outcome [1] 0 0
Secondary PK endpoint: Tmax
Timepoint [1] 0 0
pre-dose and 0.25, 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, and 48 hours post-dose
Secondary outcome [2] 0 0
Secondary PK endpoint: Tlag
Timepoint [2] 0 0
pre-dose and 0.25, 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, and 48 hours post-dose
Secondary outcome [3] 0 0
Secondary PK endpoint: T½ el
Timepoint [3] 0 0
pre-dose and 0.25, 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, and 48 hours post-dose
Secondary outcome [4] 0 0
Secondary PK endpoint: Kel
Timepoint [4] 0 0
pre-dose and 0.25, 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, and 48 hours post-dose
Secondary outcome [5] 0 0
Secondary PK endpoint: Cl/F
Timepoint [5] 0 0
pre-dose and 0.25, 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, and 48 hours post-dose
Secondary outcome [6] 0 0
Secondary PK endpoint: Vz/F
Timepoint [6] 0 0
pre-dose and 0.25, 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, and 48 hours post-dose
Secondary outcome [7] 0 0
Adverse event profile
Timepoint [7] 0 0
Day -1 to Day 9

Eligibility
Key inclusion criteria
1. Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), =18 and =59 years old at time of screening.
2. Body mass index (BMI) >18.5 and <30.0 kg/m2 and body weight =50.0 kg for males and =45.0 kg for females.
3. Healthy as defined by:

1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
3. the absence of clinically significant history of constipation, diarrhea, or irregular bowel transit in the last 4 weeks.
4. the absence of clinically significant history of irritable bowel syndrome (IBS) of any type.
5. the absence of current or history of ischemic colitis.
6. the absence of any other gastrointestinal disease which could interfere with the absorption of orally-administered medication.
4. Female subjects of non-childbearing potential must be:

1. post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented follicle-stimulating hormone (FSH) levels =40 mIU/mL at screening; or
2. surgically sterile (bilateral oophorectomy, hysterectomy or tubal ligation at least 3 months prior to dosing).
5. Sexually active female subjects of childbearing potential and non-sterile male subjects must be willing to use an acceptable contraceptive method throughout the study as detailed in section 11.1.
6. Willing to take off dentures or mouth piercing at the time of dosing (for Treatment A).
7. Able to understand the study procedures and provide signed informed consent form (ICF) to participate in the study.
Minimum age
18 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any clinically significant (in the opinion of the Investigator) abnormal finding at physical examination at screening.
2. Any clinically significant (in the opinion of the Investigator) abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
3. Positive pregnancy test or lactating female subject.
4. Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or Day -1.
5. Known allergic reactions to any excipient in the formulations.
6. History of hypersensitivity to 5-hydroxytryptamine 3 receptor (5-HT3) receptor antagonists or agonists.
7. Clinically significant ECG abnormalities (Fridericia's corrected QT interval [QTcF] >450 ms for males and >470 ms for females).
8. Clinically significant vital signs abnormalities (systolic BP lower than 90 or over 160 mmHg, diastolic BP lower than 50 or over 95 mmHg, or HR less than 45 bpm) at screening.
9. Clinically significant orthostatic vital signs abnormalities such as decrease in systolic BP of 20 mmHg or higher, decrease in diastolic BP of 10 mmHg or higher, or increase in HR of 30 bpm or higher within 3 minutes after passing from a supine to a standing position.
10. History of significant drug abuse within 1 year prior to screening or use of drugs such as marijuana within 3 months prior to the screening visit or drugs such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives within 1 year prior to screening.
11. History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit that exceeds 14 units of alcohol per week (1 unit = 150 mL of wine, 375 mL of mid strength beer, or 30 mL of distilled alcohol 40%).
12. Use of medications within the timeframes specified in section 11.2.
13. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing or of a biological product within 90 days prior to dosing.
14. Previous participation in a clinical research study involving the administration of SMP-100.
15. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
16. Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would be likely to interfere with successful completion of the dosing procedure.
17. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/12/2021
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Chengdu SciMount Pharmatech Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a single center, Phase 1, randomized, open-label, single-dose, 3 treatment, 3-period, 6-sequence, crossover study designed to compare the PK of SMP-100 dissolved in water for oral administration with SMP-100 tablets under fasting conditions, and to evaluate the effect of food on the bioavailability of SMP-100 tablets in healthy subjects.
Trial website
https://clinicaltrials.gov/study/NCT05029518
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Polasek
Address 0 0
CMAX Clinical Research Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05029518