Metastatic Castration Resistant Prostate CancerPhase 1NCT03776968
A Study Evaluating HC-1119 Single-Dose Pharmacokinetics and Effect of Food on Its Pharmacokinetics
A Phase 1 study testing HC1119 in people with Metastatic Castration Resistant Prostate Cancer, run by Hinova Pharmaceuticals Inc. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer
- What is being tested?
- HC1119
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2017to 3 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily signed the informed consent form.
- Healthy Chinese male aged between 18-45 years old (inclusive).
- Weight ≥ 50.0 kg, and BMI between 19.0-26.0 kg/m2 (inclusive) at screening. BMI = weight (kg) / height2 (m2).
- 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.
- 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.
- Able to maintain a consistency of good communication with the investigators, and understand and comply with all the requirements of this study.
Who cannot join
- A history of cardiovascular, lung, hepatic, renal, respiratory, nervous system, musculoskeletal, endocrine, or GI disease, or a history of other serious systemic diseases.
- 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.
- 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).
- Administered any prescription drugs, Chinese herbal medicine, OTC drugs, or food supplements (including vitamins) within 4 weeks prior to the study.
- 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).
- 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).
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- Recent history (in the past 3 years) and/or current medical history of autonomic dysfunction (such as recurrent syncope and palpitations).
- History of medication abuse or a positive urine drug screen within 12 months prior to the study.
- 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.
- 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.
- Donated or lost blood ≥ 400 ml of blood within 3 months prior to the study.
- Received treatment with any investigational drug or participated in any clinical trial within 3 months prior to the study.
- Requiring a special diet and unable to follow a standardized diet.
- Overconsumption of tea, coffee, and/or caffeinated beverages daily (more than 8 cups, 1 cup = 250 ml).
- Consumed grapefruit or product containing grapefruit (such as jam) within 1 week prior to receiving the investigational drug.
- Positive HIV, HBsAg, HCV, or syphilis test result.
- Cannot complete this study for any other reasons, or determined by the investigator to be unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Evaluating HC-1119 Single-Dose Pharmacokinetics and Effect of Food on Its Pharmacokinetics in Healthy Chinese Adults
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.
- Being tested
- HC1119
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC1119Drug
oral
| Study group | Role | What they receive |
|---|---|---|
| HC1119 | Experimental | Fasting state:40 mg, 80 mg, 160 mg; After meal: 160mg; Receives: Drug: HC1119 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from time 0 to infinity (∞) (AUC0-∞)
Measured: From the first dose of the study drug to day 50
Area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration(AUC0-t)
Measured: From the first dose of the study drug to day 50
Peak concentration (Cmax)
Measured: From the first dose of the study drug to day 50
Peak time (Tmax)
Measured: From the first dose of the study drug to day 50
Elimination half life (t1/2)
Measured: From the first dose of the study drug to day 50
Apparent clearance (CL/F) (prototype)
Measured: From the first dose of the study drug to day 50
Apparent volume of distribution (Vd/F) (prototype)
Measured: From the first dose of the study drug to day 50
Mean residence time (MRT)
Measured: From the first dose of the study drug to day 50
Secondary outcomes (1)
Number of patients with adverse events
Safety measures
Measured: From the first dose of the study drug to day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start24 Oct 2017
- Primary completion15 Jan 2018
- Study completion3 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hinova Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776968
- Sponsor's protocol ID
- HC-1119-PK
- Status last verified
- Oct 2020
- First submitted
- 11 Dec 2018
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating HC-1119 Single-Dose Pharmacokinetics and Effect of Food on Its Pharmacokinetics in Healthy Chinese Adults
- ClinicalTrials.gov ID
- NCT03776968
- Acronym / sponsor ID
- HC-1119-PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hinova Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HC1119 | Experimental | Drug: HC1119Fasting state:40 mg, 80 mg, 160 mg; After meal: 160mg; |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Voluntarily signed the informed consent form.
- Healthy Chinese male aged between 18-45 years old (inclusive).
- Weight ≥ 50.0 kg, and BMI between 19.0-26.0 kg/m2 (inclusive) at screening. BMI = weight (kg) / height2 (m2).
- 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.
- 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.
Key exclusion criteria (17 listed)
- A history of cardiovascular, lung, hepatic, renal, respiratory, nervous system, musculoskeletal, endocrine, or GI disease, or a history of other serious systemic diseases.
- 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.
- 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).
- Administered any prescription drugs, Chinese herbal medicine, OTC drugs, or food supplements (including vitamins) within 4 weeks prior to the study.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HC1119oral | Drug | HC1119 |
Primary outcome
Area under the plasma concentration-time curve from time 0 to infinity (∞) (AUC0-∞)
Time frame: From the first dose of the study drug to day 50
Area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration(AUC0-t)
Time frame: From the first dose of the study drug to day 50
Peak concentration (Cmax)
Time frame: From the first dose of the study drug to day 50
Peak time (Tmax)
Time frame: From the first dose of the study drug to day 50
Elimination half life (t1/2)
Time frame: From the first dose of the study drug to day 50
Apparent clearance (CL/F) (prototype)
Time frame: From the first dose of the study drug to day 50
Apparent volume of distribution (Vd/F) (prototype)
Time frame: From the first dose of the study drug to day 50
Mean residence time (MRT)
Time frame: From the first dose of the study drug to day 50
1 secondary outcome
Number of patients with adverse events
Time frame: From the first dose of the study drug to day 50
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HC1119 in people with Metastatic Castration Resistant Prostate Cancer, run by Hinova Pharmaceuticals Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve from time 0 to infinity (∞) (AUC0-∞) (time frame: From the first dose of the study drug to day 50). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.