A Phase I, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of single oral dose of HMPL-689 in Healthy Adult Participants
- Conditions
- B-cell Non-Hodgkin LymphomasCancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphomaCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
- Registration Number
- ACTRN12616000451404
- Lead Sponsor
- INC Research Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 56
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 greater than or equal to 19.0 and less than or equal to 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.
1. Family history of premature coronary artery 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 tests, especially for liver or renal function
4. Clinically significant findings in ECG, blood pressure, and heart rate, as determined by the Investigator
5. Subjects at risk for tuberculosis (TB), which is defined as:
a. Current clinical or laboratory evidence of active TB
b. History of TB
c. A positive QuantiFERON (Registered Trademark) 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 Day1
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 the feces
15. History of significant allergic disease (e.g. allergy 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 1 year before randomization/ enrollment
18. Unlikely to comply with the clinical study protocol; e.g.,uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
19. 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method