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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02631642




Registration number
NCT02631642
Ethics application status
Date submitted
14/12/2015
Date registered
16/12/2015

Titles & IDs
Public title
A Study of HMPL-689 in Healthy Volunteers
Scientific title
A Phase I,Randomized,Double Blinded,Placebo-controlled,Dose-escalating Study of the Safety,Tolerability and Pharmacokinetics of HMPL-689 in Healthy Volunteers
Secondary ID [1] 0 0
2015-689-00AU2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HMPL-689
Treatment: Drugs - HMPL-689 placebo

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.

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.


Treatment: Drugs: HMPL-689
selective PI3Kd inhibitor

Treatment: Drugs: HMPL-689 placebo
placebo of HMPL-689
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
dose limited toxicities evaluated with NCI CTCAE v4.03
Timepoint [1] 0 0
within 28 days after the first dose
Secondary outcome [1] 0 0
maximum plasma concentration calculated with Blood samples
Timepoint [1] 0 0
within 29 days after the first dose
Secondary outcome [2] 0 0
time to reach maximum concentration calculated with Blood samples
Timepoint [2] 0 0
within 29 days after the first dose

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2017
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3001 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hutchison Medipharma Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter
Address 0 0
Nucleus Network Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02631642