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

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ClinicalTrials.gov Identifier: NCT02105129
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Brief 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)


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis (RA) Drug: HMPL-523 Drug: Placebo Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL-523
Study Start Date : May 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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Arm Intervention/treatment
Experimental: HMPL-523
Single/Multiple Ascending Dose. oral administration, a single dose of 5, 20, 50, 100, 200 and 300 mg (Part A) and multiple dose of HMPL-523 at dose level based on result of Part A
Drug: HMPL-523
HMPL-523: Oral administration with a single dose of 5, 20, 50, 100, 200 and 300 mg in Part A, followed by multiple doses of selected strength in Part B Other Name: NA
Other Name: HMPL-523 acetate

Placebo Comparator: Placebo
Placebo: oral administration
Drug: Placebo
Oral administration
Other Name: HMPL-523 Placebo




Primary Outcome Measures :
  1. To assess number of participants with adverse events as a measure of safety and tolerability during dose escalating [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. To measure the plasma concentration of HMPL-523 in single and repeated doses [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105129


Locations
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Australia, Victoria
Nucleus Network Limited
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Principal Investigator: Jason Lickliter, MD Nucleus Network Ltd
Study Director: Yan Wu, MD Hutchison Medipharma Limited

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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT02105129     History of Changes
Other Study ID Numbers: 2014-523-00AU1
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases