AzTrials
AzTrials

Advanced Breast CancerPhase 1NCT06290466

Clinical Study on Pharmacokinetics of FCN-437c Capsule and Its Effect on QT Interval in Healthy Subjects

A Phase 1 study testing Low dose group and High dose group in people with Advanced Breast Cancer, run by Ahon Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial in healthy subjects.In healthy subjects, 300mg and 400mg FCN-437c capsules were taken orally for a single time. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Advanced Breast Cancer
What is being tested?
Low dose group and High dose group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteChina
Study dates
11 Nov 2022to 8 Feb 2023
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1．Healthy adult male and female subjects (not less than 1/3 of either sex); 2．18~45 years old (including boundary values)After bilateral oophorectomy; 3．The body mass index (BMI) should be between 19.0 and 26.0 kg/m2 (including boundary values), and the weight of male subjects should not be less than 50 kg and that of female subjects should not be less than 45 kg; 4．Voluntarily sign informed consent 5．The subjects were able to communicate well with the investigators and complete the test according to protocol.

Who cannot join

  • Patients who meet any of the following conditions are not allowed to enter this clinical study：
  • After a comprehensive physical examination, vital signs, laboratory examination (blood routine, blood biochemistry, coagulation function, urine routine) and other abnormalities and clinical significance;
  • Hyperkalemia, hypokalemia, hypermagnesia, hypomagnesemia, hypercalcemia or hypocalcemia, which is abnormal and clinically significant as determined by the investigator;
  • Abnormal 12-lead ECG results were clinically significant, QTcF≥450 ms, PR interval ≥200 ms;QRS group duration ≥120ms;
  • Hepatitis B surface antigen or hepatitis B core antibody, hepatitis C antibody, HIV antibody or syphilis antibody positive;
  • Any drug that inhibits or induces liver drug metabolism enzymes has been used within 30 days prior to the screening period
Show all 24Show fewer
  • Use any drug known to prolong the QT interval within 30 days prior to the screening period
  • Use of any prescription, over-the-counter, herbal or food supplements, such as vitamins and calcium supplements, in the 14 days prior to the screening period;
  • A history of any clinically serious medical conditions or conditions that the investigator believes may affect the results of the study, including but not limited to circulatory, respiratory, endocrine, nervous, digestive, urinary, or blood, immune, psychiatric, or metabolic disorders;
  • Have any conditions that may affect drug absorption, such as gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy, history of inflammatory bowel;
  • History of organic heart disease, heart failure, myocardial infarction, angina pectoris, coronary artery bypass grafting, angioplasty, stent stenting, congestive heart failure, uncontrolled hypotension, left ventricular ejection fraction lower than the lower limit of normal location, unexplained arrhythmia, ventricular tachycardia, atrioventricular block, and prolonged QT syndromeOr have symptoms of prolongation QT syndrome and a family history (as shown by genetic evidence or by a close relative who died of sudden cardiac death at a young age);
  • Patients who have undergone any surgery within 6 months prior to the screening period;
  • Allergy, such as a known history of allergy to two or more substances;Or who may be allergic to the drug or its excipients (e.g. Lactose T80, silica, sodium stearfumarate, etc.) as determined by the investigator;
  • Binge drinking or regular drinking in the 6 months preceding the screening period, i.e. drinking more than 14 units of alcohol per week (1 unit =360mL beer or 45 mL spirits with 40% alcohol or 150 mL wine);Or positive alcohol breath test results during the screening period;
  • Use of nicotine-containing products from 3 months prior to screening to the period of study participation;
  • Those who have a history of drug abuse or drug use 3 months before the screening period;Or positive urine drug test during screening;
  • Habitual users of grapefruit juice or excessive amounts of tea, coffee and/or caffeinated beverages who were unable to abstain during the trial period;
  • Patients with a history of needle fainting and blood fainting, difficulty in blood collection or inability to tolerate venous puncture blood collection
  • Participation in any other clinical trials (including drug and device trials) within 3 months prior to the screening period;
  • Those who were vaccinated within 1 month prior to screening or planned to be vaccinated during the trial period;
  • Pregnant or lactating women;
  • Participants who planned to have children or donate sperm during the study period and six months after completion of the study, or did not agree that participants and their spouses should use strict contraceptive methods during the study period and six months after completion of the study
  • Patients who had blood loss or blood donation of up to 400 mL within 3 months prior to the screening period, or received a blood transfusion within 1 month
  • Subjects with any factors deemed unsuitable for participation in the study by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

Other trials in China

About this study

Official title: A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Design to Evaluate the Pharmacokinetics and Effects on QT Interval of a Single Oral Dose of FCN-437c Capsule in Healthy Subjects.

This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial in healthy subjects.In healthy subjects, 300mg and 400mg FCN-437c capsules were taken orally for a single time. C-QTc effect model was used to evaluate the influence of blood concentration on QT interval, and the pharmacokinetic characteristics and safety of FCN-437c were also evaluated.Based on the C-QTc effect model, this study quantitatively analyzed the relationship between ΔΔQTcF and blood concentration, and evaluated the upper limit of 90% bilateral confidence interval of ΔΔQTcF corresponding to the geometric mean of Cmax at clinically relevant dose of FCN-437c capsule.

This study plans to set up 2 dose groups, low-dose group 300mg and high-dose group 400mg.Nine healthy subjects were planned to be enrolled in each dose group, with a 2:1 ratio of placebo control.

This study was carried out in the order of dose from low to high. After the administration of the low-dose group (300mg) and the safety assessment on the fourth day after administration, the study of the high-dose group (400mg) was decided through comprehensive evaluation.

Being tested
Low dose group, High dose group
Keywords
QT interval

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low dose groupDrug

    Also called FCN-437c capsule or FCN-437c capsule Placebo

    300 mg,single dose.

  • High dose groupDrug

    Also called FCN-437c capsule or FCN-437c capsule Placebo

    400 mg, single dose.

Study groups in NCT06290466
Study groupRoleWhat they receive
FCN-437c capsuleExperimentalfasting oral, single dose.Specification :100mg
Receives: Drug: Low dose group; Drug: High dose group
FCN-437c capsule PlaceboPlacebo comparatorfasting oral,single dose.Specification :100mg
Receives: Drug: Low dose group; Drug: High dose group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ΔΔQTcF

    The Cmax geometric mean corresponds to the upper 90% bilateral confidence interval of ΔΔQTcF

    Measured: 2hours before administration and 48hours and 192hours after administration

Secondary outcomes (16)

  1. adverse events

    The number, frequency and incidence of adverse events

    Measured: Trial period to day 21 after administration

  2. Physical examination

    Descriptive statistics on physical examination indicators visited and their changes from baseline

    Measured: From 1 day before administration to 21 days after administration

  3. Axillary temperature

    Descriptive statistics of vital signs at each visit and their change from baseline

    Measured: From 2.0 hours before administration to 21 days after administration

  4. blood pressure

    Descriptive statistics of vital signs at each visit and their change from baseline

    Measured: From 2.0 hours before administration to 21 days after administration

  5. pulse

    Descriptive statistics of vital signs at each visit and their change from baseline

    Measured: From 2.0 hours before administration to 21 days after administration

  6. Ecg monitoring and electrocardiogram

    QTcF

    Measured: Trial period to day 21 after administration

  7. laboratory examination

    Descriptive statistics were collected for each laboratory indicator visited and its change from baseline

    Measured: Trial period to day 21 after administration

  8. Plasma concentration and pharmacokinetic parameters

    Cmax

    Measured: 60 minutes before dosing to day 9 after dosing

  9. Plasma concentration and pharmacokinetic parameters

    AUC0-t

    Measured: 60 minutes before dosing to day 9 after dosing

  10. Plasma concentration and pharmacokinetic parameters

    AUC0-∞

    Measured: 60 minutes before dosing to day 9 after dosing

  11. Plasma concentration and pharmacokinetic parameters

    Tmax

    Measured: 60 minutes before dosing to day 9 after dosing

  12. Plasma concentration and pharmacokinetic parameters

    T1/2

    Measured: 60 minutes before dosing to day 9 after dosing

  13. Plasma concentration and pharmacokinetic parameters

    CL/F

    Measured: 60 minutes before dosing to day 9 after dosing

  14. Plasma concentration and pharmacokinetic parameters

    VZ/F

    Measured: 60 minutes before dosing to day 9 after dosing

  15. Plasma concentration and pharmacokinetic parameters

    MRT

    Measured: 60 minutes before dosing to day 9 after dosing

  16. Plasma concentration and pharmacokinetic parameters

    AUC_%Extrap

    Measured: 60 minutes before dosing to day 9 after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2024
  2. Study start11 Nov 2022
  3. Primary completion8 Feb 2023
  4. Study completion8 Feb 2023

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06290466
Sponsor's protocol ID
FCN-437c-CP-004
Status last verified
Feb 2024
First submitted
18 Feb 2024
Last updated
4 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhao L, Sun Y, Yang X, Tian L, Li L, Wang F, Niu X, Diao L, Li H. No QTc prolongation with CDK 4/6 inhibitor FCN-437c: results of a concentration-QTc analysis from a dedicated study in adult healthy subjects. Front Pharmacol. 2024 Aug 12;15:1433663. doi: 10.3389/fphar.2024.1433663. eCollection 2024.

    PubMed 39188943

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Low dose group and High dose group in people with Advanced Breast Cancer, run by Ahon Pharmaceutical Co., Ltd. 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 1 inclusion and 24 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 4 Mar 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. Some participants in this study may receive a placebo. 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?

ΔΔQTcF (time frame: 2hours before administration and 48hours and 192hours after administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06290466, which also lists 1 linked publication.

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 4 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in