The PK/PD Study of SHR0532 Tablets in Healthy Subjects

Hypertension Clinical Trial

Official title:

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR0532 Tablets in Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03645278
• Other study ID #: SHR0532-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 24, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: August 2018
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Yuanwei Jia, Ph.D.
• Phone: +86-15155324471
• Email: jiayuanwei123925[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 30, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. males or females, aged 18-45

2. subjects have no cardiovascular disease, with sitting blood pressure: 90mmHg =SBP<140mmHg and 60mmHg =DBP<90mmHg;

3. 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

4. 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

Exclusion Criteria:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin > 1.5 x ULN during screening/baseline;

2. Serum creatinine>ULN)during screening/baseline;

3. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) test positive;

4. Known postural hypotension; the numeric difference of systolic blood pressure between both upper limbs >20mmHg;

5. A clinical history of arrhythmia;subjects with Electrocardiogram QTc prolongation(male>450ms;female>460ms)during screening;

6. A clinical history of hyperuricemia;serum uric acid > the upper limit of normal value (ULN) during screening;

7. A clinical history of diabetes;fasting plasma glucose or hemoglobin A1c exceeded the upper limit of normal value (ULN) during screening;

8. Subjects with previous GI discomfort -abdominal pain, diarrhea, and nausea 3 months prior to screening;

9. A clinical history of acute or chronic kidney disease;

10. 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;

12.Pregnant or Serum ß-hCG > 5mIU/mL at baseline or women who are breastfeeding; etc.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• SHR0532
Ascending dose oral adminstration
• Placebo
Ascending dose oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events and serious adverse events		Pre-dose to 5 days after dose administration
Secondary	Area under the plasma concentration versus time curve (AUC) of SHR-0532		Pre-dose to 5 days after dose administration
Secondary	Maximum observed serum concentration (Cmax) of SHR-0532		Pre-dose to 5 days after dose administration
Secondary	Time to maximum observed serum concentration (tmax) of SHR-0532		Pre-dose to 5 days after dose administration
Secondary	Time to elimination half-life (t1/2) of SHR-0532		Pre-dose to 5 days after dose administration
Secondary	Apparent total clearance of the drug from plasma after oral administration (CL/F) of SHR-0532		Pre-dose to 5 days after dose administration
Secondary	Apparent volume of distribution after non-intravenous administration (V/F) of SHR-0532		Pre-dose to 5 days after dose administration
Secondary	Renal clearance of the drug from plasma (CLR) of SHR-0532		Pre-dose to 5 days after dose administration
Secondary	Cumulative amount of unchanged drug excreted into the urine(Ae) of SHR-0532		Pre-dose to 5 days after dose administration