A Phase I Study of Hetrombopag Olamine in Healthy Adult Volunteers

NCT01830660 | Completed Phase 1

• 1 other identifier: SHR-TPOP1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Adverse events

  up to 4 weeks

• Change in vital signs

  up to 4 weeks

• Change in clinical laboratory parameters

  up to 4 weeks

Study Arms (2)

hetrombopag

EXPERIMENTAL

hetrombopag either at 2.5,5,10,20,30 or 40mg, p.o. once daily

Drug: Hetrombopag Olamine Tablets

placebo

PLACEBO COMPARATOR

Subjects will be randomized (5:1 eltrombopag : placebo) to receive either eltrombopag or placebo.

Drug: placebo

Interventions

Hetrombopag Olamine Tablets DRUG

hetrombopag

placebo DRUG

placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• Must be a healthy male between the ages of 18 to 45 years, inclusive.
• Must have a BMI between 19 to 28 kg/m2, inclusive and a total body weight ≥50 kg.
• Platelet counts must be within the normal range.
• Subjects must be free of any clinically significant disease based on medical history and physical examination.
• Clinical laboratory tests (complete blood count \[CBC\], blood chemistries, and urinalysis) must be within the normal limits or clinically acceptable.
• Must be nonsmokers, defined as not having smoked tobacco or used chewing tobacco or nicotine.
• 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.

You may not qualify if:

• History of hypersensitivity to hetrombopag olamine or its components.
• 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.
• History of deep vein thrombosis, or any other thromboembolic event.
• History or presence of conditions that may place the subject at increased risk as determined by the investigator.
• History of thrombocytopenia or bleeding due to abnormal platelet number or function.
• History of platelet clumping that prevents reliable measurement of platelet counts.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Study Officials

• Maozhi Liang, Dr

  West China Hospital

  PRINCIPAL INVESTIGATOR

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: December 25, 2012
• First Posted: April 12, 2013
• Study Start: April 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 6, 2015

Record last verified: 2013-04

Locations

CN (1)