Healthy VolunteerPhase 1NCT03973632
Pharmacokinetic Study of SH-1028 Tablets in Healthy Subjects Under Fasting and Fed Conditions
A Phase 1 study testing SH-1028 Tablets in people with Healthy Volunteer, run by Nanjing Sanhome Pharmaceutical, Co., Ltd..
Trial summary
To evaluate the food-effect of SH-1028 Tablets by pharmacokinetics in healthy subjects under fasting and fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- SH-1028 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Dec 2019
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Subject with acceptable laboratory results.
- BMI between 19 and 26; Weight between 50 and 80 kg
- Not allowed to smoke or drink during the trial.
- Subject should be willing to contracept during the study and until 6 months after completion of study.
Who cannot join
- Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.
- History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity
- Addicted to smoking and drinking.
- Hemorrhage over 200mL in 3 months before the trial.
- Other conditions not suitable for trial, by judgement of investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I, Open-label, Single-center, Crossover Design of Food-effect Study of SH-1028 Tablets in Healthy Subjects
To evaluate the food-effect of SH-1028 Tablets by pharmacokinetics in healthy subjects under fasting and fed conditions.
Read the detailed description
By analyzing safety and pharmacokinetics of SH-1028 Tablets in healthy subjects, pharmacokinetic characteristic will be evaluated mainly under fasting and fed conditions.Safety including AE/SAE is also a significant secondary objective.
- Conditions
- Healthy Volunteer
- Being tested
- SH-1028 Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SH-1028 TabletsDrug
200mg of SH-1028 Tablets, orally once every cycle.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Fasting at last 10h before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 1，Feeding with high-fat diet within 30 minutes before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 2. Each cycle is 4 days with a 3-days interval. Receives: Drug: SH-1028 Tablets |
| Group B | Experimental | Feeding with high-fat diet within 30 minutes before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 1，Fasting at last 10h before taking 200mg（two pills） of SH-1028 tablets on Day 1 of cycle 2. Each cycle is 4 days with a 3-days interval. Receives: Drug: SH-1028 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to infinity (AUC)
Measured: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2(Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to last measurable concentration [AUC(0-t)]
Measured: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Every cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of time to Cmax (tmax)
Measured: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Every cycle is 4 days with a 3-days interval).
Secondary outcomes (8)
Adverse event（AE）rate and serious adverse event（SAE）rate
Measured: From signing of informed consent to ending of the trial, about 25 days.
Pharmacokinetic of SH-1028 Tablets by assessment of maximum plasma concentration (Cmax)
Measured: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of terminal rate constant (λz) [
Measured: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of Terminal half life (t1/2）
Measured: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of apparent plasma clearance (CL/F)
Measured: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of apparent volume of distribution (Vz/F)
Measured: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of Mean Residence Time（MRT）
Measured: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of AUC[%Extrap obs],the rate of AUC(t-∞) to AUC
Measured: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study startJul 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973632
- Sponsor's protocol ID
- SHC013-I-03
- Status last verified
- May 2019
- First submitted
- 31 May 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Single-center, Crossover Design of Food-effect Study of SH-1028 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03973632
- Acronym / sponsor ID
- SHC013-I-03
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Jun 2019 (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.
To evaluate the food-effect of SH-1028 Tablets by pharmacokinetics in healthy subjects under fasting and fed conditions.
Detailed description
By analyzing safety and pharmacokinetics of SH-1028 Tablets in healthy subjects, pharmacokinetic characteristic will be evaluated mainly under fasting and fed conditions.Safety including AE/SAE is also a significant secondary objective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: SH-1028 TabletsFasting at last 10h before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 1，Feeding with high-fat diet within 30 minutes before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 2. Each cycle is 4 days with a 3-days interval. |
| Group B | Experimental | Drug: SH-1028 TabletsFeeding with high-fat diet within 30 minutes before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 1，Fasting at last 10h before taking 200mg（two pills） of SH-1028 tablets on Day 1 of cycle 2. Each cycle is 4 days with a 3-days interval. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Subject with acceptable laboratory results.
- BMI between 19 and 26; Weight between 50 and 80 kg
- Not allowed to smoke or drink during the trial.
- Subject should be willing to contracept during the study and until 6 months after completion of study.
Key exclusion criteria (5 listed)
- Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.
- History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity
- Addicted to smoking and drinking.
- Hemorrhage over 200mL in 3 months before the trial.
- Other conditions not suitable for trial, by judgement of investigator.
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 |
|---|---|---|
| SH-1028 Tablets200mg of SH-1028 Tablets, orally once every cycle. | Drug | Group A, Group B |
Primary outcome
Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to infinity (AUC)
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2(Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to last measurable concentration [AUC(0-t)]
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Every cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of time to Cmax (tmax)
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Every cycle is 4 days with a 3-days interval).
8 secondary outcomes
Adverse event（AE）rate and serious adverse event（SAE）rate
Time frame: From signing of informed consent to ending of the trial, about 25 days.
Pharmacokinetic of SH-1028 Tablets by assessment of maximum plasma concentration (Cmax)
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of terminal rate constant (λz) [
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of Terminal half life (t1/2）
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of apparent plasma clearance (CL/F)
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of apparent volume of distribution (Vz/F)
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of Mean Residence Time（MRT）
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of AUC[%Extrap obs],the rate of AUC(t-∞) to AUC
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SH-1028 Tablets in people with Healthy Volunteer, run by Nanjing Sanhome Pharmaceutical, Co., Ltd..
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhou Huan, associate professor (13665527160, zhouhuan@bbmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to infinity (AUC) (time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2(Each cycle is 4 days with a 3-days interval).). 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?
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 4 Jun 2019.