A Trial of SHR6390 in Healthy Caucasian Volunteers

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301804
• Other study ID #: SHR6390-001AUS
• Status: Completed
• Phase: Phase 1
• Start date: March 12, 2020
• Est. completion date: September 28, 2020

Study information

• Verified date: September 2020
• Source: Atridia Pty Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 28, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• SHR6390
a selective small-molecule CDK4/6 inhibitor

Locations

Country	Name	City	State
Australia	Linear Clinical Research	Melbourne	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Atridia Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

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