Clinical trial NCT03776968: A Study Evaluating HC-1119 Single-Dose Pharmacokinetics and Effect of Food on Its Pharmacokinetics
Official title: A Study Evaluating HC-1119 Single-Dose Pharmacokinetics and Effect of Food on Its Pharmacokinetics in Healthy Chinese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Castration Resistant Prostate Cancer
Lead sponsor: Hinova Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-17
Enrollment: 47
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase I study evaluating HC-1119 single-dose pharmacokinetics and effect of food on its pharmacokinetics in healthy Chinese adults. The study primary objective is to evaluate the HC-1119 pharmacokinetic characteristics and the effect of food on its pharmacokinetics in healthy Chinese males, subsequent to a single oral administration of HC-1119 with different doses in healthy Chinese males.


Eligibility criteria: Inclusion Criteria:

1. Voluntarily signed the informed consent form.
2. Healthy Chinese male aged between 18-45 years old (inclusive).
3. Weight ≥ 50.0 kg, and BMI between 19.0-26.0 kg/m2 (inclusive) at screening. BMI = weight (kg) / height2 (m2).
4. Defined as "healthy" based on past medical history, physical examination, vital signs, laboratory tests, 12-Lead ECG, and chest x-ray performed at screening. All examination results must be within the normal range corresponding to the subject's age and gender, or determined by the investigator as "no clinical significance (NCS)" when the result is out of range.
5. All male subjects and their female spouses/sexual partners with child-bearing potential must adopt continuous and effective contraceptive methods, that is, two forms of contraception should be performed spontaneously (including at least one barrier method), from the initiation of screening and the whole study period to at least three months after administration.
6. Able to maintain a consistency of good communication with the investigators, and understand and comply with all the requirements of this study.

Exclusion Criteria:

1. A history of cardiovascular, lung, hepatic, renal, respiratory, nervous system, musculoskeletal, endocrine, or GI disease, or a history of other serious systemic diseases.
2. A clinically significant history of drug allergies or a history of specific allergic disease (asthma, urticaria, eczema dermatitis), especially being allergic to any ingredients of the study drug or formulation.
3. Suffered (within 1 week prior to the study) or currently suffering from febrile illness, symptomatic viral infection, bacterial infection (including upper respiratory tract infection), or fungal infection (except skin infection).
4. Administered any prescription drugs, Chinese herbal medicine, OTC drugs, or food supplements (including vitamins) within 4 weeks prior to the study.
5. Administered any inducers or inhibitors of hepatic drug metabolism within 1 month prior to the study (such as: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, and omeprazole; inhibitors - antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, and antihistamines).
6. History of seizures within 12 months prior to the study, including any history of febrile seizures, loss of consciousness, or transient ischemic attack, and any condition that increases the risk of seizures (such as history of stroke, cerebral arteriovenous malformation, traumatic brain injury with coma requiring hospitalization, and lacunar infarct).
7. Recent history (in the past 3 years) and/or current medical history of autonomic dysfunction (such as recurrent syncope and palpitations).
8. History of medication abuse or a positive urine drug screen within 12 months prior to the study.
9. Smokers or those who smoked more than 10 cigarettes per day (or equivalent amounts of tobacco) within 3 months prior to the study, or those who are unable to stop smoking during the entire course of the study.
10. History of alcohol abuse or those with regular consumption of alcoholic beverages (daily consumption exceeding 14 units of alcohol, 1 unit = 360 ml of beer, 45 ml of 40% liquor, or 150 ml of wine) within 6 months prior to the study, or having a positive breath alcohol test result.
11. Donated or lost blood ≥ 400 ml of blood within 3 months prior to the study.
12. Received treatment with any investigational drug or participated in any clinical trial within 3 months prior to the study.
13. Requiring a special diet and unable to follow a standardized diet.
14. Overconsumption of tea, coffee, and/or caffeinated beverages daily (more than 8 cups, 1 cup = 250 ml).
15. Consumed grapefruit or product containing grapefruit (such as jam) within 1 week prior to receiving the investigational drug.
16. Positive HIV, HBsAg, HCV, or syphilis test result.
17. Cannot complete this study for any other reasons, or determined by the investigator to be unsuitable for this study.

Primary outcomes:
measure: Area under the plasma concentration-time curve from time 0 to infinity (∞) (AUC0-∞)
timeFrame: From the first dose of the study drug to day 50
measure: Area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration(AUC0-t)
timeFrame: From the first dose of the study drug to day 50
measure: Peak concentration (Cmax)
timeFrame: From the first dose of the study drug to day 50
measure: Peak time (Tmax)
timeFrame: From the first dose of the study drug to day 50
measure: Elimination half life (t1/2)
timeFrame: From the first dose of the study drug to day 50
measure: Apparent clearance (CL/F) (prototype)
timeFrame: From the first dose of the study drug to day 50
measure: Apparent volume of distribution (Vd/F) (prototype)
timeFrame: From the first dose of the study drug to day 50
measure: Mean residence time (MRT)
timeFrame: From the first dose of the study drug to day 50
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: From the first dose of the study drug to day 50
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changhai Hospital Ethics Committee
Study officials:
References: