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EndometriosisPhase 1NCT06554548

A Study Evaluating Food Effect on Pharmacokinetics of HS-10518

A Phase 1 study testing HS-10518 in people with Endometriosis, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective of this study is to evaluate the effect of food on the pharmacokinetics of HS-10518 Read more about this study

Who is it for?
Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Endometriosis
What is being tested?
HS-10518
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
No sites listed yet
Study dates
15 Aug 2024to 30 Aug 2025
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 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Sign the informed consent before the study procedure，and fully understand the test contents, process and possible adverse reactions, be able to complete the study in accordance with the study regulations.
  • Premenopausal adult female subjects (age ≥18 years old, calculated on the day of signing the informed consent).
  • female subjects weigh at least 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index is in the range of 18.0 ~ 28.0 (including the critical value).
  • agreed to use effective contraception from signing the informed consent until 3 months after the last dose of medication and not plan to have a child during the study, not plan to donate oocytes within 6 months after the last dose (only nonpharmacologic contraception could be used during the study).

Who cannot join

  • Her/his Physical examination, vital signs examination, electrocardiogram or clinical laboratory examination, etc., are abnormal and clinically meaningful according to the investigator's judgment.
  • Hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), HIV antibody (anti-HCV) HIV antibody (anti-HIV) positive at screening
  • Those with alanine aminotransferase (Alter) and aspartate aminotransferase (Aster) exceeded the upper limit of normal values at screening
  • Those with abnormal and clinically significant ECG results (e.g., QTcF ≥ 450 ms) at screening
  • Those with a prior history of breast cancer, genitourinary cancer, any estrogen-dependent tumor, or any other clinically significant gynecological disease
  • Subjects with a history of osteoporosis
Show all 30Show fewer
  • Those with a history of migraine, epilepsy, convulsions, depression, or clinically significant depressive state
  • Those with a history of thyroid or parathyroid dysfunction or thyroid-stimulating hormone (TSH), free triiodothyronine (FT3) and free thyroxine (FT4) exceeded the upper limit of normal values at screening
  • Clinically significant gastrointestinal complaints within 7 days before the first dose
  • Those who have a history of severe gastrointestinal diseases (such as Crohn's disease, ulcerative colitis, reflux esophagitis, chronic gastritis, etc.) or a history of surgery that may affect the absorption, distribution, metabolism and excretion of the trial drug (except for simple appendectomy or hernia surgery), and judged by the investigator unsuitable for enrollment
  • Those who have consumed excessive amounts of tea, coffee, and/or caffeinated beverages within 3 months prior to screening (The average is more than 8 cups per day, 1 cup=200 mL)
  • Those who have consumed grapefruit or grapefruit products within 48 hours prior to the first dose.
  • Those who have consumed caffeine-rich and/or xanthine-rich foods or products (such as: coffee, tea, chocolate, and caffeinated carbonated beverages such as cola, etc.), tobacco-containing products (such as cigarettes, etc.), alcohol, or alcoholic products within 48 hours prior to the first dose.
  • Those who drink regularly within 3 months before screening (i.e., drink more than 14 units of alcohol per week, 1 unit = 14 g of alcohol, equivalent to 360 mL of beer or 45 mL of spirits or 150 mL of wine with 40% alcohol, equivalent to drinking 10 bottles of beer or 1 kg of white wine or 3 bottles of red wine per week), or those who cannot stop drinking alcohol products during the study, or those who have a positive alcohol breath test result.
  • Those who smoked more than 5 cigarettes per day on average within 3 months before screening, or those who could not stop using any tobacco products (including e-cigarettes) during the study.
  • Those who have a history of drug abuse, drug dependence, or drug use, or a positive urine screening for drug abuse
  • Those who are prone to allergic reactions, or allergic constitution (such as those who are allergic to pollen, two or more drugs/foods), or those who are known to be allergic to the components of the test drug, and judged by the investigator to be unsuitable for participating in the study.
  • Those who have lost a lot of blood (>400 mL) or donated blood or received blood transfusion within 3 months before screening, or who plan to donate blood during the study period to 1 month after completing the study.
  • Those with a diagnosis of infertility or more than two previous spontaneous abortions.
  • Those with follicle-stimulating hormone (FSH) ≥ 35 U/L at screening.
  • Those who are postpartum, post-abortion or within 6 months after breastfeeding.
  • Those who are pregnant, lactating, or have a positive pregnancy test at screening.
  • Those who have used any drugs (prescription drugs, over-the-counter drugs, Chinese herbal medicines and dietary supplements including vitamins, etc.) within 30 days before the first dose (or at least 7 times the time of the corresponding elimination half-life, whichever is longer)
  • Use of hormonal contraception: those who have used short-acting preparations containing sex hormones (oral, transdermal, intravaginal, etc.) within 3 months before the first dose or long-acting preparations containing sex hormones (any long-acting injections or implants) within 6 months before the first dose.
  • Those who have used the vaccine within 30 days before the first dose or plan to use the vaccine during the study and within 7 days after the end of the study.
  • Those who have participated in other drug clinical trials and used trial drugs within 3 months prior to screening.
  • Those who have unprotected sexual activity within 14 days prior to the first dose.
  • Those who have special dietary requirements and cannot follow a uniform diet.
  • Those who have a history of fainting needle and blood sickness, or who have difficulty in blood collection as assessed by the investigator, or who cannot tolerate venipuncture/indwelling needle blood collection
  • Other circumstances or reasons for which the investigator considered the subject to be unfit to participate in the study

About this study

The primary objective of this study is to evaluate the effect of food on the pharmacokinetics of HS-10518

Conditions
Endometriosis
Being tested
HS-10518
Medical subject headings
Endometriosis

What participants receive

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

  • HS-10518Drug

    Treatment A: Single oral dose of HS-10518 160 mg tablet under fasted conditions Treatment B: Single oral dose of HS-10518 160 mg tablet after a high-fat meal

Study groups in NCT06554548
Study groupRoleWhat they receive
Sequence ABExperimentalfasting, fed
Receives: Drug: HS-10518
Sequence BAExperimentalfed, fasting
Receives: Drug: HS-10518

What is being measured

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

  1. Peak plasma concentration (Cmax) of HS-10518

    Measured: predose and within 48 hours postdose in each treatment period

  2. Area under the plasma concentration versus time curve (AUC0-t) of HS-10518

    within 48 hours postdose in each treatment period

    Measured: within 48 hours postdose in each treatment period

Timeline

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

  1. First posted15 Aug 2024
  2. Study start15 Aug 2024 (estimated)
  3. Primary completion30 Jul 2025 (estimated)
  4. Study completion30 Aug 2025 (estimated)

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
Crossover
Masking
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06554548
Sponsor's protocol ID
HS-10518-103
Status last verified
Aug 2024
First submitted
12 Aug 2024
Last updated
15 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-10518 in people with Endometriosis, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

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 4 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Peak plasma concentration (Cmax) of HS-10518 (time frame: predose and within 48 hours postdose in each treatment period). The study lists 2 primary outcomes in all. 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 NCT06554548.

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 15 Aug 2024.

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