Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects

NCT05088343 | Completed Phase 1

• 1 other identifier: SHR8735-110
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of hetrombopag on the pharmacokinetics of rosuvastatin in healthy subjects.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Peak plasma concentration (Cmax)

  0-72 hours post dose

• Area Under the plasma concentration vs time curve (AUC0-72)

  0-72 hours post dose

• Area under the blood concentration vs time curve (AUC0-inf)

  0-infinity

Secondary Outcomes (2)

• Other pharmacokinetics parameters of rosuvastatin

  0-72 hours post dose

• The number of volunteers with adverse events as a measure of safety and tolerability

  up to Day 20

Study Arms (1)

Treatment

EXPERIMENTAL

rosuvastatin alone and then in combination with hetrombopag

Drug: Rosuvastatin; Drug: Hetrombopag

Interventions

Rosuvastatin DRUG

Single oral dose of rosuvastatin on Day 1 or co-administered with hetrombopag on Day 11.

Treatment

Hetrombopag DRUG

7.5 mg hetrombopag was administered on Day 6 to Day 11.

Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
• Ability to complete the study as required by the protocol;
• Healthy male or female subjects aged 18 to 55 (including 18 and 55) at the date of signing the informed consent;
• Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26).

You may not qualify if:

• Allergic constitution;
• History of drug use, or drug abuse screening positive;
• Alcoholic or often drinkers;
• History of deep vein thrombosis, or any other thromboembolic event;
• A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
• Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Xueying General Ding

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

Rosuvastatin Calcium; hetrombopag

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xueying Ding

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: rosuvastatin alone and then in combination with hetrombopag

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: October 21, 2021
• Study Start: September 7, 2020
• Primary Completion: January 16, 2021
• Study Completion: January 16, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-02

Locations

CN (1)