A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective of this study is to assess the safety and tolerability of a single dose of up to 800 mg in Part A (evaluated in planned steps of 5, 20, 50, 100, 200, 300 mg under fasted conditions, followed by 300, 400, 600 and 800 mg HMPL-523 under fed conditions of a standard meal, followed by multiple doses of 200, 300, 400 and 500 mg of HMPL-523 in Part B, in healthy male volunteers.

The secondary objective is to determine the pharmacokinetic profile of single (Part A) and multiple (Part B) oral doses of HMPL-523 in healthy male volunteers and to determine the preliminary effect of food (Part C）

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hutchison Medipharma Limited

Criteria

Inclusion Criteria:

• Informed consent must be obtained in writing for all subjects before enrollment into the study

• Healthy male subjects aged 18 to 45years inclusive at the time of screening

• Body mass index ≥19.0 and ≤ 30.0 kg/m2

• No clinically significant abnormalities as determined by medical history and physical examination, especially with regard to the liver, bile and gastrointestinal systems

• No clinically significant laboratory values and urinalysis, as determined by the clinical Investigator.

• No clinically significant findings in ECG, blood pressure and heart rate, as determined by the clinical Investigator.

• Willing to comply with the contraceptive requirements of the study and must not donate sperm during the study or for 3 months afterwards. Subjects must agree to use a condom or to abstain from sexual intercourse throughout the trial and for 30 days afterwards.

Exclusion Criteria:

• Family history of premature Coronary Heart Disease

• Any condition requiring the regular use of any medication

• Exposure to prescription medications or to drugs known to interfere with metabolism of drugs within 30 days prior to Day 1

• Exposure to any other medication, including over-the counter medications, herbal remedies and vitamins 14 days prior to first dose

• Participation in another study with any investigational drug in the 30 days preceding Day 1 of the study

• Treatment in the previous 3 months with any drug known to have a well defined potential for toxicity to a major organ

• Current smoker of more than 10 cigarettes or equivalent / day prior to commencing the study and unable to completely stop smoking during the study

• Be in the exclusion period of any previous study with investigational drugs

• Symptoms of a clinically significant illness in the 3 months before the study

• Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs

• Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease, Hemorrhoids or anal diseases with regular or recent presence of blood in feces

• History of significant allergic disease (e.g. Allergic to medications) and acute phase of allergic rhinitis in the previous 2 weeks before randomization or any food allergy

• Blood or plasma donation of more than 500 ml during the previous 30 Days before randomization and/or more than 50 ml in the 2 weeks prior to screening

• Known positive test for HIV

• Known positive test for hepatitis B or C, unless caused by immunization

• Current evidence of drug abuse or history of drug abuse within one year before randomization

• History of alcohol abuse or active alcoholism as defined in Appendix A Definition of alcohol abuse

• Mental condition rendering the subject incapable to understand the nature, scope, and possible consequences of the study

• Adults under guardianship and people with restriction of freedom by administrative or legal decisions

• Unlikely to comply with the clinical study protocol; e.g. uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study

• Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol