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CompletedNCT02631642Updated Aug 17, 2017

A Study of HMPL-689 in Healthy Volunteers

A Phase 1 interventional study of HMPL-689 and HMPL-689 placebo in Healthy Volunteers, sponsored by Hutchison Medipharma Limited. Completed at 1 site in Australia. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-17.

Sponsored by Hutchison Medipharma Limited · Phase 1, Interventional, and Health services research

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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

Read the 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.

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Conditions studied

  • Healthy Volunteers
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In context

Lead sponsor

Hutchison Medipharma Limited is the lead sponsor of 66 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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:

    1. Current clinical or laboratory evidence of active TB
    2. History of TB
    3. A positive QuantiFERON® test at screening or within 6 months prior to Day 1
  6. Any medical condition requiring regular use of medication
  7. Exposure to prescription medications within 30 days prior to Day 1
  8. Exposure to any other medication, including over-the-counter medications, herbal remedies and vitamins 14 days prior to first dose (except for paracetamol)
  9. Participation in another clinical trial with any investigational drug within 30 days of Day 1
  10. Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity to a major organ
  11. Current smoker of more than 10 cigarettes or equivalent/ day prior to commencing the study and unable to completely stop smoking during the study
  12. Symptoms of a clinically significant illness in the 3 months before the study
  13. Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
  14. Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease, hemorrhoids or anal diseases with regular or recent presence of blood in feces
  15. 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
  16. 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)
  17. Current evidence of drug abuse or history of drug abuse within one year before randomization/ enrollment
  18. Mental condition rendering the subject incapable to understand the nature, scope, and possible consequences of the study
  19. 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
  20. 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
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Study design

Phase
Phase 1
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugHMPL-689

    selective PI3Kδ inhibitor

    Also known as: Huchison Medipharma

  • DrugHMPL-689 placebo

    placebo of HMPL-689

    Also known as: Huchison Medipharma

06

What researchers measure

Primary outcomes

  1. dose limited toxicities evaluated with NCI CTCAE v4.03

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

    Time frame: within 28 days after the first dose

Secondary outcomes

  1. maximum plasma concentration calculated with Blood samples

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

    Time frame: within 29 days after the first dose

  2. time to reach maximum concentration calculated with Blood samples

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

    Time frame: within 29 days after the first dose

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Study locations

1 site
  • Nucleus Network
    Melbourne, Victoria 3001, Australia
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02631642
Lead sponsor
Hutchison Medipharma Limited
Responsible party
Sponsor
First posted
Dec 16, 2015
Start date
Mar 23, 2016
Primary completion
Oct 26, 2016
Completion
Feb 28, 2017
Last update
Aug 17, 2017

Study contacts

Jason Lickliter
principal investigator · Nucleus Network Ltd

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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