Healthy VolunteersPhase 1NCT04301804
A Trial of SHR6390 in Healthy Caucasian Volunteers
A Phase 1 study testing SHR6390 in people with Healthy Volunteers, run by Atridia Pty Ltd. at 1 site in Australia.
Trial summary
This is a Phase 1, single center, single dose, open-label clinical study to evaluate the pharmacokinetics, safety and tolerability of SHR6390 under fasting conditions in healthy caucasian volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- SHR6390
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Mar 2020to 28 Sep 2020
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy Caucasian male and female subjects aged 18 to 45 years, inclusive at screening
- 2. Male body weight ≥50 kg, female body weight ≥45 kg, BMI between 19.0 and 29.0 kg/m2, inclusive
- 3. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests
- 4. Female subjects agree not to be pregnant or lactating from beginning of the study screening and will maintain contraception for 90 days after trial completion
- 5. Males agree to use contraception with their female partner and refrain from donating sperm during the study and for at least 90 days after SHR6390 administration
- 6. Able and willing to abstain from caffeine- and xanthine-containing products, alcohol, grapefruit-related fruit juices, tobacco/nicotine-containing products, and alcohol for 48 hours prior to check-in until final PK blood sample
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- 7. Able and willing to abstain from eating and drinking poppy seed-containing products and grapefruit-related fruits and juices
- 8. Able and willing to abstain from strenuous exercise
- 9. Willing and able to comply with all scheduled visits, study procedures, and provides written informed consent
Who cannot join
- 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neuropsychiatric, or allergic disease
- 2. Had a severe infection, trauma or major surgery within 4 weeks of screening; plan to have a surgery during the trial
- 3. A past medical history of clinically significant cardiovascular conditions
- 4. Sitting systolic blood pressure (BP) ≥140 mmHg or <90 mmHg; diastolic BP ≥90 mmHg or <50 mmHg on a single measurement
- 5. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy
- 6. Subject has a history of type 1 hypersensitivity to any medication
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- 7. Evidence of substance abuse or a history of substance abuse in the last two years
- 8. Subject is positive for drugs of abuse,cotinine or alcohol at screening and check-in; may be repeated once at the discretion of the investigator
- 9. History of severe hypoglycemia
- 10. Subjects who use more than 5 tobacco or nicotine-containing products per day or will not abstain from using these products starting from at least 48 hours prior to check-in and during the study
- 11. History of regular alcohol consumption in the past 3 months exceeding an average weekly intake of 14 standard drinks
- 12. Use of medications affecting liver metabolism within 1 month prior to dosing
- 13. Treatment with an investigational drug within 3 months or 5 half-lives
- 14. Blood donation or loss of more than 200 mL of blood within 1 month of dosing or 400 mL of blood within 3 months, or 400 mL within 3 months.
- 15. Any other major illness/condition that, in the investigator's judgment, substantially increased the risk associated with the subject's participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Single Center, Open-Label, Single Dose Pharmacokinetic Study of Reformulated SHR6390 Tablets Under Fasting Conditions in Healthy Caucasian Volunteers
This is a Phase 1, single center, single dose, open-label clinical study to evaluate the pharmacokinetics, safety and tolerability of SHR6390 under fasting conditions in healthy caucasian volunteers
Read the detailed description
The objective of this study is to determine the comparative pharmacokinetics, safety and tolerability of single oral dose of reformulated SHR6390 in healthy volunteers under fasting conditions.
Each subject will receive a single dose of SHR6390, blood samples will be collected before dosing and at various time points up to 144 hours after drug administration, safety and the statistical analysis of the pharmacokinetic data will be obtained from this study
- Conditions
- Healthy Volunteers
- Being tested
- SHR6390
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR6390Drug
a selective small-molecule CDK4/6 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 | Experimental | Subjects will be randomised to receive a single dose of SHR6390 at Dose level 1 Receives: Drug: SHR6390 |
| Dose level 2 | Experimental | Subjects will be randomised to receive a single dose of SHR6390 at Dose level 2 Receives: Drug: SHR6390 |
| Dose level 3 | Experimental | Subjects will be randomised to receive a single dose of SHR6390 at Dose level 3 Receives: Drug: SHR6390 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with laboratory tests findings of potential clinical importance
Measured: through study completion, an average of 1 year
Number of subjects with adverse events (AEs)
Measured: Screening up to study completion, an average of 1 year
Number of subjects with clinically significant abnormal ECG QT Interval
Measured: Screening up to study completion, an average of 1 year
Secondary outcomes (8)
Pharmacokinetic - Cmax
Maximum observed plasma concentration (Cmax) of SHR6390
Measured: 7 days
Pharmacokinetic - AUC∞
Area under the concentration-time curve from time 0 to infinity of SHR6390
Measured: 7 days
AUC from time 0 to the time of the last quantifiable concentration (AUClast) of SHR6390
Measured: Day 1 pre-dose to Day 7 (144h) post-dose
Pharmacokinetic - AUClast
Area under the concentration-time curve from time 0 to time of last quantifiable concentration
Measured: 7 days
Pharmacokinetic - Tmax
Time to Cmax of SHR6390
Measured: 7 days
Pharmacokinetic - CL/F
Apparent clearance of SHR6390
Measured: 7 days
Pharmacokinetic - Vz/F
Apparent volume of distribution during terminal phase of SHR6390
Measured: 7 days
Pharmacokinetic - t1/2
Terminal elimination half-life
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start12 Mar 2020
- Primary completion28 May 2020
- Study completion28 Sep 2020
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 36 healthy volunteer subjects will be enrolled in this study. 12 subjects subjects will take a single dose of SHR6390 in each of the 3 dose cohorts
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301804
- Sponsor's protocol ID
- SHR6390-001AUS
- Status last verified
- Sep 2020
- First submitted
- 1 Mar 2020
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Single Center, Open-Label, Single Dose Pharmacokinetic Study of Reformulated SHR6390 Tablets Under Fasting Conditions in Healthy Caucasian Volunteers
- ClinicalTrials.gov ID
- NCT04301804
- Acronym / sponsor ID
- SHR6390-001AUS
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 10 Mar 2020 (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.
This is a Phase 1, single center, single dose, open-label clinical study to evaluate the pharmacokinetics, safety and tolerability of SHR6390 under fasting conditions in healthy caucasian volunteers
Detailed description
The objective of this study is to determine the comparative pharmacokinetics, safety and tolerability of single oral dose of reformulated SHR6390 in healthy volunteers under fasting conditions.
Each subject will receive a single dose of SHR6390, blood samples will be collected before dosing and at various time points up to 144 hours after drug administration, safety and the statistical analysis of the pharmacokinetic data will be obtained from this study
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A total of 36 healthy volunteer subjects will be enrolled in this study. 12 subjects subjects will take a single dose of SHR6390 in each of the 3 dose cohorts
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 | Experimental | Drug: SHR6390Subjects will be randomised to receive a single dose of SHR6390 at Dose level 1 |
| Dose level 2 | Experimental | Drug: SHR6390Subjects will be randomised to receive a single dose of SHR6390 at Dose level 2 |
| Dose level 3 | Experimental | Drug: SHR6390Subjects will be randomised to receive a single dose of SHR6390 at Dose level 3 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 1. Healthy Caucasian male and female subjects aged 18 to 45 years, inclusive at screening
- 2. Male body weight ≥50 kg, female body weight ≥45 kg, BMI between 19.0 and 29.0 kg/m2, inclusive
- 3. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests
- 4. Female subjects agree not to be pregnant or lactating from beginning of the study screening and will maintain contraception for 90 days after trial completion
- 5. Males agree to use contraception with their female partner and refrain from donating sperm during the study and for at least 90 days after SHR6390 administration
Key exclusion criteria (15 listed)
- 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neuropsychiatric, or allergic disease
- 2. Had a severe infection, trauma or major surgery within 4 weeks of screening; plan to have a surgery during the trial
- 3. A past medical history of clinically significant cardiovascular conditions
- 4. Sitting systolic blood pressure (BP) ≥140 mmHg or <90 mmHg; diastolic BP ≥90 mmHg or <50 mmHg on a single measurement
- 5. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy
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 |
|---|---|---|
| SHR6390a selective small-molecule CDK4/6 inhibitor | Drug | Dose level 1, Dose level 2, Dose level 3 |
Primary outcome
Number of subjects with laboratory tests findings of potential clinical importance
Time frame: through study completion, an average of 1 year
Number of subjects with adverse events (AEs)
Time frame: Screening up to study completion, an average of 1 year
Number of subjects with clinically significant abnormal ECG QT Interval
Time frame: Screening up to study completion, an average of 1 year
8 secondary outcomes
Pharmacokinetic - Cmax
Time frame: 7 days
Pharmacokinetic - AUC∞
Time frame: 7 days
AUC from time 0 to the time of the last quantifiable concentration (AUClast) of SHR6390
Time frame: Day 1 pre-dose to Day 7 (144h) post-dose
Pharmacokinetic - AUClast
Time frame: 7 days
Pharmacokinetic - Tmax
Time frame: 7 days
Pharmacokinetic - CL/F
Time frame: 7 days
Pharmacokinetic - Vz/F
Time frame: 7 days
Pharmacokinetic - t1/2
Time frame: 7 days
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 14 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
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 SHR6390 in people with Healthy Volunteers, run by Atridia Pty 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 9 inclusion and 15 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 14 Jul 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?
Number of subjects with laboratory tests findings of potential clinical importance (time frame: through study completion, an average of 1 year). 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 14 Jul 2022.