A Phase I Study of Hetrombopag Olamine in Healthy Adult Volunteers

A Phase I, Randomized, Placebo-controlled, Ascending Single And Multiple Oral Dose Study To Investigate Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Hetrombopag Olamine (SHR8735 Olamine) In Healthy Subjects

Hetrombopag Olamine made by Jiangsu Hengrui Medicine co Ltd. has shown an effect of increasing platelet count in animal and human. This study is designed in dose escalation fashion to evaluate safety, pharmacokinetics and efficacy of Hetrombopag Olamine.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: placebo; Drug: Hetrombopag Olamine Tablets

Detailed Description

1. To evaluate safety and tolerability of Hetrombopag Olamine.
2. To investigate pharmacokinetics of Hetrombopag Olamine Under fasting conditions.
3. To obtain pharmacodynamics information of Hetrombopag Olamine on platelet count elevation in healthy volunteers.
4. To determine preliminary regimen for phase II study.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Subject must be adequately informed of the nature and risks of the study, able to understand the risks associated with the study, and are willing to provide written informed consent prior to screening.
2. Must be a healthy male between the ages of 18 to 45 years, inclusive.
3. Must have a BMI between 19 to 28 kg/m2, inclusive and a total body weight ≥50 kg.
4. Platelet counts must be within the normal range.
5. Subjects must be free of any clinically significant disease based on medical history and physical examination.
6. Clinical laboratory tests (complete blood count [CBC], blood chemistries, and urinalysis) must be within the normal limits or clinically acceptable.
7. Must be nonsmokers, defined as not having smoked tobacco or used chewing tobacco or nicotine.
8. Subjects of reproductive potential with partners who are women of childbearing potential, will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 6 months after discontinuing treatment with the investigational product.

Exclusion Criteria:

1. History of hypersensitivity to hetrombopag olamine or its components.
2. History or presence of significant cardiovascular deficient, pulmonary, hepatic, gallbladder or biliary tract, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, neurological, or psychiatric disease, or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
3. History of deep vein thrombosis, or any other thromboembolic event.
4. History or presence of conditions that may place the subject at increased risk as determined by the investigator.
5. History of thrombocytopenia or bleeding due to abnormal platelet number or function.
6. History of platelet clumping that prevents reliable measurement of platelet counts.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: hetrombopag; hetrombopag either at 2.5,5,10,20,30 or 40mg, p.o. once daily	Drug: Hetrombopag Olamine Tablets
PLACEBO_COMPARATOR: placebo; Subjects will be randomized (5:1 eltrombopag : placebo) to receive either eltrombopag or placebo.	Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in platelet count above baseline(%)on Day1,3,5,8,10,12,15,17,19,22,25,28 after dosing	up to 4 weeks
Composite pharmacokinetic (PK) parameters of eltrombopag following a single dose of eltrombopag	For 5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	up to 4 weeks
Change in vital signs	up to 4 weeks
Change in clinical laboratory parameters	up to 4 weeks

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Maozhi Liang, Dr, West China Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: December 25, 2012
• First Submitted That Met QC Criteria: April 11, 2013
• First Posted (ESTIMATE): April 12, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 6, 2015
• Last Update Submitted That Met QC Criteria: April 3, 2015
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: SHR-TPOP1