A Trial of SHR6390 in Healthy Caucasian Volunteers

NCT04301804 | Completed Phase 1 DMC

• 1 other identifier: SHR6390-001AUS
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Number of subjects with laboratory tests findings of potential clinical importance

  through study completion, an average of 1 year

• Number of subjects with adverse events (AEs)

  Screening up to study completion, an average of 1 year

• Number of subjects with clinically significant abnormal ECG QT Interval

  Screening up to study completion, an average of 1 year

Secondary Outcomes (8)

• Pharmacokinetic - Cmax

  7 days

• Pharmacokinetic - AUC∞

  7 days

• 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

• Pharmacokinetic - AUClast

  7 days

• Pharmacokinetic - Tmax

  7 days

Study Arms (3)

Dose level 1

EXPERIMENTAL

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

Drug: SHR6390

Dose level 2

EXPERIMENTAL

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

Drug: SHR6390

Dose level 3

EXPERIMENTAL

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

Drug: SHR6390

Interventions

SHR6390 DRUG

a selective small-molecule CDK4/6 inhibitor

Dose level 1; Dose level 2; Dose level 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy Caucasian male and female subjects aged 18 to 45 years, inclusive at screening
• \. Male body weight ≥50 kg, female body weight ≥45 kg, BMI between 19.0 and 29.0 kg/m2, inclusive
• \. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests
• \. 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
• \. 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
• \. 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
• \. Able and willing to abstain from eating and drinking poppy seed-containing products and grapefruit-related fruits and juices
• \. Able and willing to abstain from strenuous exercise
• \. Willing and able to comply with all scheduled visits, study procedures, and provides written informed consent

You may not qualify if:

• \. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neuropsychiatric, or allergic disease
• \. Had a severe infection, trauma or major surgery within 4 weeks of screening; plan to have a surgery during the trial
• \. A past medical history of clinically significant cardiovascular conditions
• \. Sitting systolic blood pressure (BP) ≥140 mmHg or \<90 mmHg; diastolic BP ≥90 mmHg or \<50 mmHg on a single measurement
• \. 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
• \. Subject has a history of type 1 hypersensitivity to any medication
• \. Evidence of substance abuse or a history of substance abuse in the last two years
• \. 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
• \. History of severe hypoglycemia
• \. 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
• \. History of regular alcohol consumption in the past 3 months exceeding an average weekly intake of 14 standard drinks
• \. Use of medications affecting liver metabolism within 1 month prior to dosing
• \. Treatment with an investigational drug within 3 months or 5 half-lives
• \. 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.
• \. Any other major illness/condition that, in the investigator's judgment, substantially increased the risk associated with the subject's participation

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (1)

Linear Clinical Research

Melbourne, Western Australia, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: March 10, 2020
• Study Start: March 12, 2020
• Primary Completion: May 28, 2020
• Study Completion: September 28, 2020
• Last Updated: July 14, 2022

Record last verified: 2020-09

Locations

AU (1)