Healthy VolunteersPhase 1NCT05029518

3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability

A Phase 1 study testing SMP-100 in people with Healthy Volunteers, run by Chengdu SciMount Pharmatech Co., Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: SMP-100
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteAustralia
Study dates: 9 Sep 2021to 10 Dec 2021
Phase: Phase 1
Are there results?: None posted in the registry

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 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.
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.
Healthy as defined by:
the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
the absence of clinically significant history of constipation, diarrhea, or irregular bowel transit in the last 4 weeks.

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the absence of clinically significant history of irritable bowel syndrome (IBS) of any type.
the absence of current or history of ischemic colitis.
the absence of any other gastrointestinal disease which could interfere with the absorption of orally-administered medication.
Female subjects of non-childbearing potential must be:
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
surgically sterile (bilateral oophorectomy, hysterectomy or tubal ligation at least 3 months prior to dosing).
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.
Willing to take off dentures or mouth piercing at the time of dosing (for Treatment A).
Able to understand the study procedures and provide signed informed consent form (ICF) to participate in the study.

Who cannot join

Any clinically significant (in the opinion of the Investigator) abnormal finding at physical examination at screening.
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.
Positive pregnancy test or lactating female subject.
Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or Day -1.
Known allergic reactions to any excipient in the formulations.
History of hypersensitivity to 5-hydroxytryptamine 3 receptor (5-HT3) receptor antagonists or agonists.

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Clinically significant ECG abnormalities (Fridericia's corrected QT interval [QTcF] >450 ms for males and >470 ms for females).
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.
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.
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.
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%).
Use of medications within the timeframes specified in section 11.2.
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.
Previous participation in a clinical research study involving the administration of SMP-100.
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.
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.
Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Trial locations and contacts

1 site in 1 country.

Australia1 site

CMAX Clinical Research Pty Ltd
Adelaide, SA 5000

Other trials in Australia

About this study

Official 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

Read the detailed description

SMP-100 is a novel serotonin receptor 3 (5-HT3) partial agonist. The compound is under development in an oral dosage form for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-d). The study drug also has the potential to treat chemotherapy induced nausea and emesis and diarrhea due to carcinoid syndrome.

A single ascending dose (SAD) and multiple ascending dose (MAD) clinical study (study number SMP-100-101) evaluating the safety, tolerability, and PK profile of orally administered SMP-100 in healthy volunteers is ongoing. Regarding safety, there have been no clinically relevant abnormal vital signs, ECGs, laboratory results or SAEs.

In each period, subjects will receive a single 4 mg 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.

The study will include a screening visit from Day -28 to Day -2. Eligible subjects will be admitted to the clinical site on Day -1 and will be confined until completion of the assessments on Day 9. There will be a washout period of at least 72 hours between doses.

Primary objectives:

To compare the PK of SMP-100 dissolved in water for oral administration with SMP-100 tablets under fasting conditions, following a single dose in healthy subjects.
To evaluate the effect of a high-fat, high-calorie meal on the bioavailability of SMP-100 tablets, following a single dose in healthy subjects.

Secondary objective:

To evaluate the safety and tolerability of two SMP-100 oral formulations when administered to healthy subjects.

Conditions: Healthy Volunteers
Being tested: SMP-100

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SMP-100Drug
Also called ALB-137391(a), CSTI-300, SMP-100 oral solution, SMP-100 tablet
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.

Study groups in NCT05029518
Study group	Role	What they receive
Treatment A: SMP-100 dissolved in water administered under fasting conditions	Experimental	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. Receives: Drug: SMP-100
Treatment B: SMP-100 tablets administered under fasting conditions	Experimental	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. Receives: Drug: SMP-100
Treatment C: SMP-100 tablets administered under fed conditions	Experimental	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. Receives: Drug: SMP-100

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary PK endpoints: AUC( 0-inf)
Area under the concentration-time curve from time zero to infinity (extrapolated)
Measured: 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 PK endpoint: AUC(0-t)
Area under the concentration-time curve from time zero until the last observed concentration
Measured: 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 PK endpoint: Cmax
Maximal observed concentration
Measured: 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 outcomes (7)

Secondary PK endpoint: Tmax
Time when the maximal concentration is observed
Measured: 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 PK endpoint: Tlag
Time of observation prior to the first observation with a measurable (non-zero)
Measured: 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 PK endpoint: T½ el
Terminal elimination half-life
Measured: 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 PK endpoint: Kel
Elimination rate constant
Measured: 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 PK endpoint: Cl/F
Apparent body clearance
Measured: 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 PK endpoint: Vz/F
Apparent volume of distribution
Measured: 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
Adverse event profile
Nature, incidence and severity of treatment-emergent adverse events
Measured: Day -1 to Day 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 202110 Dec 2021

First posted31 Aug 2021
Study start9 Sep 2021
Primary completion30 Nov 2021
Study completion10 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies 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: Crossover
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05029518
Sponsor's protocol ID: SciMount
Status last verified: Aug 2021
First submitted: 22 Aug 2021
Last updated: 11 Mar 2022
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT05029518
Acronym / sponsor ID: SciMount
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Chengdu SciMount Pharmatech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 9 Sep 2021 (actual)
Primary completion: 30 Nov 2021 (actual)
Study completion: 10 Dec 2021 (actual)
First posted: 31 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary objectives:

To compare the PK of SMP-100 dissolved in water for oral administration with SMP-100 tablets under fasting conditions, following a single dose in healthy subjects.
To evaluate the effect of a high-fat, high-calorie meal on the bioavailability of SMP-100 tablets, following a single dose in healthy subjects.

Secondary objective:

To evaluate the safety and tolerability of two SMP-100 oral formulations when administered to healthy subjects.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment A: SMP-100 dissolved in water administered under fasting conditions	Experimental	Drug: SMP-10012 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.
Treatment B: SMP-100 tablets administered under fasting conditions	Experimental	Drug: SMP-10012 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.
Treatment C: SMP-100 tablets administered under fed conditions	Experimental	Drug: SMP-10012 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.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (15 listed)

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.
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.
Healthy as defined by:
Female subjects of non-childbearing potential must be:
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.

Key exclusion criteria (17 listed)

Any clinically significant (in the opinion of the Investigator) abnormal finding at physical examination at screening.
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.
Positive pregnancy test or lactating female subject.
Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or Day -1.
Known allergic reactions to any excipient in the formulations.

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
SMP-100Also: ALB-137391(a), CSTI-300, SMP-100 oral solution, SMP-100 tabletIn 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.	Drug	Treatment A: SMP-100 dissolved in water administered under fasting conditions, Treatment B: SMP-100 tablets administered under fasting conditions, Treatment C: SMP-100 tablets administered under fed conditions

Primary outcome

Primary PK endpoints: AUC( 0-inf)
Time frame: 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
Area under the concentration-time curve from time zero to infinity (extrapolated)
Primary PK endpoint: AUC(0-t)
Time frame: 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
Area under the concentration-time curve from time zero until the last observed concentration
Primary PK endpoint: Cmax
Time frame: 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
Maximal observed concentration

7 secondary outcomes

Secondary PK endpoint: Tmax
Time frame: 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 PK endpoint: Tlag
Time frame: 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 PK endpoint: T½ el
Time frame: 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 PK endpoint: Kel
Time frame: 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 PK endpoint: Cl/F
Time frame: 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 PK endpoint: Vz/F
Time frame: 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
Adverse event profile
Time frame: Day -1 to Day 9

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.

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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.

Thomas Polasek principal investigator

CMAX Clinical Research Pty Ltd

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 SMP-100 in people with Healthy Volunteers, run by Chengdu SciMount Pharmatech Co., Ltd. at 1 site in Australia.

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 15 inclusion and 17 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 11 Mar 2022. 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 Australia. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Primary PK endpoints: AUC( 0-inf) (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05029518.

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 11 Mar 2022.