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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04301804




Registration number
NCT04301804
Ethics application status
Date submitted
1/03/2020
Date registered
10/03/2020
Date last updated
1/10/2020

Titles & IDs
Public title
A Trial of SHR6390 in Healthy Caucasian Volunteers
Scientific title
A Phase I, Randomized, Single Center, Open-Label, Single Dose Pharmacokinetic Study of Reformulated SHR6390 Tablets Under Fasting Conditions in Healthy Caucasian Volunteers
Secondary ID [1] 0 0
SHR6390-001AUS
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 - SHR6390

Experimental: Dose level 1 - Subjects will be randomised to receive a single dose of SHR6390 at Dose level 1

Experimental: Dose level 2 - Subjects will be randomised to receive a single dose of SHR6390 at Dose level 2

Experimental: Dose level 3 - Subjects will be randomised to receive a single dose of SHR6390 at Dose level 3


Treatment: Drugs: SHR6390
a selective small-molecule CDK4/6 inhibitor

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with laboratory tests findings of potential clinical importance
Timepoint [1] 0 0
through study completion, an average of 1 year
Primary outcome [2] 0 0
Number of subjects with adverse events (AEs)
Timepoint [2] 0 0
Screening up to study completion, an average of 1 year
Primary outcome [3] 0 0
Number of subjects with clinically significant abnormal ECG QT Interval
Timepoint [3] 0 0
Screening up to study completion, an average of 1 year
Secondary outcome [1] 0 0
Pharmacokinetic - Cmax - Maximum observed plasma concentration (Cmax) of SHR6390
Timepoint [1] 0 0
7 days
Secondary outcome [2] 0 0
Pharmacokinetic - AUC8 - Area under the concentration-time curve from time 0 to infinity of SHR6390
Timepoint [2] 0 0
7 days
Secondary outcome [3] 0 0
AUC from time 0 to the time of the last quantifiable concentration (AUClast) of SHR6390
Timepoint [3] 0 0
Day 1 pre-dose to Day 7 (144h) post-dose
Secondary outcome [4] 0 0
Pharmacokinetic - AUClast - Area under the concentration-time curve from time 0 to time of last quantifiable concentration
Timepoint [4] 0 0
7 days
Secondary outcome [5] 0 0
Pharmacokinetic - Tmax - Time to Cmax of SHR6390
Timepoint [5] 0 0
7 days
Secondary outcome [6] 0 0
Pharmacokinetic - CL/F - Apparent clearance of SHR6390
Timepoint [6] 0 0
7 days
Secondary outcome [7] 0 0
Pharmacokinetic - Vz/F - Apparent volume of distribution during terminal phase of SHR6390
Timepoint [7] 0 0
7 days
Secondary outcome [8] 0 0
Pharmacokinetic - t1/2 - Terminal elimination half-life
Timepoint [8] 0 0
7 days

Eligibility
Key inclusion criteria
- 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

- 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
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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

- 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

Study design
Purpose of the study
Other
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
Parallel
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/show/NCT04301804
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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
Other publications