Healthy VolunteerPhase 1NCT04006860
A Food-Effect Study of SHC014748M in Healthy Subjects
A Phase 1 study testing SHC014748M Capsules in people with Healthy Volunteer, run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of SHC014748M Capsules following single dose administration with and without a meal. 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?
- SHC014748M Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- 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
- 1. Healthy male subject,18-45 years of age.
- 2. BMI between 19 and 26; Weight between 50 and 80 kg.
- 3. Healthy medical examination ,various laboratory inspection indicators normal, or the abnormal signs have no clinical significance.
- 4. Subjects (including their partners) who are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose.
- 5. Sign the informed consent form before the study and fully understand the study content, process and possible adverse reactions.
Who cannot join
- 1. Nervous system, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, musculoskeletal system, etc. are abnormal and have clinical significance as determined by investigator.
- 2. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity.
- 3. Addicted to smoking and drinking in 3 months before the trial.
- 4. Hemorrhage over 200mL , receive blood transfusions or use blood products in 3 months before the trial.
- 5. Other conditions not suitable for trial, by judgement of investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233070
Huan Zhou, associate professor, 13665527160, zhouhuan@bbmc.edu.cn
Huaiquan Gao, associate
About this study
Official title: A Single-center, Open-label, Randomized, Two-period Crossover Food-effect Study of SHC014748M in Healthy Subjects
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of SHC014748M Capsules following single dose administration with and without a meal.
Read the detailed description
This study will be an open-label, randomized, two-period, crossover PK food effect study of SHC014748M Capsules administered orally at 200 mg.
For each of 2 study periods, subjects will be admitted to the clinical research unit on the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for each of the 2 study periods, subjects will receive a single oral dose of 200 mg SHC014748M Capsules in either the fasted or fed state. Subjects will remain at the clinical research unit for at least 72 hours after administration of study drug for collection of serial blood samples for pharmacokinetic (PK) analysis and safety monitoring.
- Conditions
- Healthy Volunteer
- Being tested
- SHC014748M Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHC014748M CapsulesDrug
SHC014748M Capsules: 200mg
| Study group | Role | What they receive |
|---|---|---|
| SHC014748M: Fast + Fed | Experimental | Participants will receive a single oral dose of SHC014748M capsules in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of SHC014748M capsules in fed condition on Day 8 of treatment period 2. Receives: Drug: SHC014748M Capsules |
| SHC014748M: Fed + Fast | Experimental | Participants will receive a single oral dose of SHC014748M capsules in fed condition on Day 1 of treatment period 1 followed by a single oral dose of SHC014748M capsules in fasted condition on Day 8 of treatment period 2. Receives: Drug: SHC014748M Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-t)
Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to last measurable concentration.
Measured: 72 hours
AUC(0-∞)
Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to infinity
Measured: 72 hours
Cmax
Pharmacokinetic of SHC014748M Capsules by assessment of maximum plasma concentration
Measured: 72 hours
Secondary outcomes (7)
tmax
Pharmacokinetic of SHC014748M Capsules by assessment of time to Cmax
Measured: 72 hours
AUC[%Extrap obs]
Pharmacokinetic of SHC014748M Capsules by assessment of AUC[%Extrap obs],the rate of AUC(t-∞) to AUC
Measured: 72 hours
t l/2
Pharmacokinetic of SHC014748M Capsules by assessment of Terminal half life
Measured: 72 hours
λz
Pharmacokinetic of SHC014748M Capsules by assessment of terminal rate constant
Measured: 72 hours
CL/F
Pharmacokinetic of SHC014748M Capsules by assessment of apparent plasma clearance
Measured: 72 hours
Vz/F
Pharmacokinetic of SHC014748M Capsules by assessment of apparent volume of distribution
Measured: 72 hours
MRT
Pharmacokinetic of SHC014748M Capsules by assessment of Mean Residence Time
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 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
- NCT04006860
- Sponsor's protocol ID
- SHC014-I-02
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 5 Jul 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 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Randomized, Two-period Crossover Food-effect Study of SHC014748M in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04006860
- Acronym / sponsor ID
- SHC014-I-02
- 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
- 5 Jul 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.
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of SHC014748M Capsules following single dose administration with and without a meal.
Detailed description
This study will be an open-label, randomized, two-period, crossover PK food effect study of SHC014748M Capsules administered orally at 200 mg.
For each of 2 study periods, subjects will be admitted to the clinical research unit on the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for each of the 2 study periods, subjects will receive a single oral dose of 200 mg SHC014748M Capsules in either the fasted or fed state. Subjects will remain at the clinical research unit for at least 72 hours after administration of study drug for collection of serial blood samples for pharmacokinetic (PK) analysis and safety monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHC014748M: Fast + Fed | Experimental | Drug: SHC014748M CapsulesParticipants will receive a single oral dose of SHC014748M capsules in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of SHC014748M capsules in fed condition on Day 8 of treatment period 2. |
| SHC014748M: Fed + Fast | Experimental | Drug: SHC014748M CapsulesParticipants will receive a single oral dose of SHC014748M capsules in fed condition on Day 1 of treatment period 1 followed by a single oral dose of SHC014748M capsules in fasted condition on Day 8 of treatment period 2. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Healthy male subject,18-45 years of age.
- 2. BMI between 19 and 26; Weight between 50 and 80 kg.
- 3. Healthy medical examination ,various laboratory inspection indicators normal, or the abnormal signs have no clinical significance.
- 4. Subjects (including their partners) who are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose.
- 5. Sign the informed consent form before the study and fully understand the study content, process and possible adverse reactions.
Key exclusion criteria (5 listed)
- 1. Nervous system, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, musculoskeletal system, etc. are abnormal and have clinical significance as determined by investigator.
- 2. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity.
- 3. Addicted to smoking and drinking in 3 months before the trial.
- 4. Hemorrhage over 200mL , receive blood transfusions or use blood products in 3 months before the trial.
- 5. 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 |
|---|---|---|
| SHC014748M CapsulesSHC014748M Capsules: 200mg | Drug | SHC014748M: Fast + Fed, SHC014748M: Fed + Fast |
Primary outcome
AUC(0-t)
Time frame: 72 hours
Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to last measurable concentration.
AUC(0-∞)
Time frame: 72 hours
Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to infinity
Cmax
Time frame: 72 hours
Pharmacokinetic of SHC014748M Capsules by assessment of maximum plasma concentration
7 secondary outcomes
tmax
Time frame: 72 hours
AUC[%Extrap obs]
Time frame: 72 hours
t l/2
Time frame: 72 hours
λz
Time frame: 72 hours
CL/F
Time frame: 72 hours
Vz/F
Time frame: 72 hours
MRT
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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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.
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 SHC014748M Capsules in people with Healthy Volunteer, run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 1 site in China.
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 5 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 5 Jul 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC(0-t) (time frame: 72 hours). 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 5 Jul 2019.