The PK/PD Study of SHR0532 Tablets in Healthy Subjects

NCT03645278 | Unknown Phase 1 DMC

• 1 other identifier: SHR0532-101
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the last four decades, several classes of diuretics have been the first line option for the therapy of widespread hypertension. However, all the classes of diuretics cause alteration of potassium homeostasis. The primary objective of this study is to assess the safety and tolerability of SHR0532 tablets in healthy subjects. In addition, this study will provide information on Pharmacokinetics and Pharmacodynamics of SHR0532 tablets in healthy subjects.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse events and serious adverse events

  Pre-dose to 5 days after dose administration

Secondary Outcomes (8)

• Area under the plasma concentration versus time curve (AUC) of SHR-0532

  Pre-dose to 5 days after dose administration

• Maximum observed serum concentration (Cmax) of SHR-0532

  Pre-dose to 5 days after dose administration

• Time to maximum observed serum concentration (tmax) of SHR-0532

  Pre-dose to 5 days after dose administration

• Time to elimination half-life (t1/2) of SHR-0532

  Pre-dose to 5 days after dose administration

• Apparent total clearance of the drug from plasma after oral administration (CL/F) of SHR-0532

  Pre-dose to 5 days after dose administration

Study Arms (2)

SHR0532

EXPERIMENTAL

Up to 5 cohorts of healthy subjects will receive a single dose of oral SHR0532 tablet.

Drug: SHR0532

Placebo

EXPERIMENTAL

Up to 5 cohorts of healthy subjects will receive a single dose of oral placebo.

Drug: Placebo

Interventions

SHR0532 DRUG

Ascending dose oral adminstration

SHR0532

Placebo DRUG

Ascending dose oral administration

Placebo

Eligibility Criteria

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

You may qualify if:

• males or females, aged 18-45
• subjects have no cardiovascular disease, with sitting blood pressure: 90mmHg ≤SBP\<140mmHg and 60mmHg ≤DBP\<90mmHg;
• body mass index (BMI) between 19 to 26, and a total body weight: male ≥50.0 kg and \<90.0 kg; female ≥45.0 kg and \<90.0 kg
• Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on electrocardiogram, X-ray, Echocardiograph and B-type ultrasonic

You may not qualify if:

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin \> 1.5 x ULN during screening/baseline;
• Serum creatinine\>ULN)during screening/baseline;
• Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) test positive;
• Known postural hypotension; the numeric difference of systolic blood pressure between both upper limbs \>20mmHg；
• A clinical history of arrhythmia；subjects with Electrocardiogram QTc prolongation（male\>450ms；female\>460ms）during screening；
• A clinical history of hyperuricemia；serum uric acid \> the upper limit of normal value (ULN) during screening;
• A clinical history of diabetes；fasting plasma glucose or hemoglobin A1c exceeded the upper limit of normal value (ULN) during screening;
• Subjects with previous GI discomfort -abdominal pain, diarrhea, and nausea 3 months prior to screening；
• A clinical history of acute or chronic kidney disease;
• Subjects with severe trauma or surgery within 3 months prior to the screening； 11.3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs (test drug half-life more than 3 months) before screening;
• Pregnant or Serum β-hCG \> 5mIU/mL at baseline or women who are breastfeeding; etc.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yuanwei Jia, Ph.D.

CONTACT

+86-15155324471; jiayuanwei123925@foxmail.com

Jie Shen, Ph.D.

CONTACT

+86-15155324471; shenjie-yjs@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2018
• First Posted: August 24, 2018
• Study Start: August 24, 2018
• Primary Completion: December 15, 2018
• Study Completion: April 30, 2019
• Last Updated: August 24, 2018

Record last verified: 2018-08