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A Study of HMPL-689 in Healthy Volunteers

Sponsor
Hutchison Medipharma Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT02631642
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
11.2
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of a single dose of HMPL-689 in healthy volunteers To determine the pharmacokinetic profile of single oral doses of HMPL-689 in healthy volunteers

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Subjects will receive a single dose of HMPL-689 or matching placebo during Day 1. The planned dose levels are: 1, 2.5, 5, 10, 20, 25 and 30 mg (about 7 cohorts of 8 subjects). In each dose cohort, 8 subjects will be randomized to receive HMPL-689 (6 subjects) or placebo (2 subjects) under fed condition with a standard meal.

For the first dose Cohort (1 mg), a sentinel group of 2 subjects (1 HMPL-689 and 1 placebo) will be dosed 24 hours prior to the planned dosing of the remaining six subjects. The decision of dose escalation or study termination will be made jointly by the principal investigator and the sponsor based on the clinical data (safety, tolerability, available PK data and clinical laboratory values). Any dose level may be repeated, reduced or split into 2 doses if deemed appropriate by the Principal Investigator and Sponsor's medical Expert.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
A Phase I,Randomized,Double Blinded,Placebo-controlled,Dose-escalating Study of the Safety,Tolerability and Pharmacokinetics of HMPL-689 in Healthy Volunteers
Actual Study Start Date :
Mar 23, 2016
Actual Primary Completion Date :
Oct 26, 2016
Actual Study Completion Date :
Feb 28, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: HMPL-689

Subjects will receive a single dose of HMPL-689 or matching placebo on Day 1. The planned dose levels in ascending order are: 1, 2.5, 5, 10, 20, 25 and 30 mg (7 dose cohorts with 8 subjects in each cohort). Within each cohort, randomization ratio of 3:1 is followed to dose 6 subjects with HMPL-689 and 2 subjects with placebo.

Drug: HMPL-689
selective PI3Kδ inhibitor
Other Names:
  • Huchison Medipharma

    		•
    Placebo Comparator: HMPL-689 placebo

    Subjects will receive a single dose of HMPL-689 or matching placebo on Day 1. The planned dose levels in ascending order are: 1, 2.5, 5, 10, 20, 25 and 30 mg (7 dose cohorts with 8 subjects in each cohort). Within each cohort, randomization ratio of 3:1 is followed to dose 6 subjects with HMPL-689 and 2 subjects with placebo.

    Drug: HMPL-689 placebo
    placebo of HMPL-689
    Other Names:
  • Huchison Medipharma

    		•

    Outcome Measures

    Primary Outcome Measures

    1. dose limited toxicities evaluated with NCI CTCAE v4.03 [within 28 days after the first dose]

      Incidence of dose limited toxicities and associated dose of HMPL-689

    Secondary Outcome Measures

    1. maximum plasma concentration calculated with Blood samples [within 29 days after the first dose]

      Blood samples will be taken to measure the levels of study drug

    2. time to reach maximum concentration calculated with Blood samples [within 29 days after the first dose]

      Blood samples will be taken to measure the levels of study drug

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

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

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

    3. Body mass index ≥19.0 and ≤ 30.0 kg/m2

    4. 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:

    1. Family history of premature Coronary Heart Disease

    2. History of immunosuppression or opportunistic infections or receipt of a live virus vaccination within the 3 months prior to screening

    3. Clinically significant abnormalities as determined by medical history physical examination, or laboratory test, especially for liver and renal function

    4. Clinically significant findings in ECG, blood pressure and heart rate, as determined by the Clinical Investigator

    5. Subjects at risk for tuberculosis (TB), which is defined as:

    6. Current clinical or laboratory evidence of active TB

    7. History of TB

    8. A positive QuantiFERON® test at screening or within 6 months prior to Day 1

    9. Any medical condition requiring regular use of medication

    10. Exposure to prescription medications within 30 days prior to Day 1

    11. Exposure to any other medication, including over-the-counter medications, herbal remedies and vitamins 14 days prior to first dose (except for paracetamol)

    12. Participation in another clinical trial with any investigational drug within 30 days of Day 1

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

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

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

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

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

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

    19. Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)

    20. Current evidence of drug abuse or history of drug abuse within one year before randomization/ enrollment

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

    22. 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

    23. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nucleus Network Melbourne Victoria Australia 3001

    Sponsors and Collaborators

    • Hutchison Medipharma Limited

    Investigators

    • Principal Investigator: Jason Lickliter, Nucleus Network Ltd

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hutchison Medipharma Limited
    ClinicalTrials.gov Identifier:
    NCT02631642
    Other Study ID Numbers:
    • 2015-689-00AU2
    First Posted:
    Dec 16, 2015
    Last Update Posted:
    Aug 17, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Aug 17, 2017