First human dosing of F230 tablets

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of Single and Multiple Administration of F230 Tablets in Healthy Adult Volunteers

This study will test whether single and multiple doses of F230 tablets are safe and how the body processes them in healthy adult volunteers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. (Industry-sponsored)
• Drugs / interventions: Sunitinib
• Locations: 1 site (Hubei, Wuhan)
• Trial ID: NCT06899815 on ClinicalTrials.gov

What this trial studies

This phase 1, single-center study enrolls healthy adult volunteers to characterize safety, tolerability, and pharmacokinetics of F230 given as single and multiple oral doses and to examine the effect of food. The first part is a randomized, double-blind, placebo-controlled, dose-escalation single-ascending-dose (SAD) phase with multiple dose cohorts (3–40 mg); the second part is a multiple-ascending-dose (MAD) phase; the third part assesses food effects. Subjects are screened for health, admitted to the phase I unit, dosed according to cohort assignment, and monitored with clinical exams and PK sampling. The primary outcomes are adverse events and pharmacokinetic parameters after single and repeated dosing.

Who should consider this trial

Good fit: Healthy men and women aged 18–45 with BMI 19–26, meeting detailed screening labs and exams and without significant medical issues are the intended participants for this phase 1 study.

Not a fit: People with pulmonary hypertension and others with active medical conditions are unlikely to receive direct therapeutic benefit from this healthy-volunteer phase 1 study.

Why it matters

Potential benefit: If successful, F230 could become an additional oral endothelin-receptor–like treatment option for pulmonary hypertension that may improve symptoms and outcomes.

How similar studies have performed: Approved endothelin-receptor antagonists have proven benefit in pulmonary arterial hypertension, but F230 is a novel compound and this is its first-in-human testing.

Eligibility criteria

Inclusion Criteria:

Volunteers must meet all of the following criteria to be selected:

1. Healthy volunteers, half male and half female, should be replaced by volunteers of the same sex;
2. Age: 18 \~ 45 years old;
3. Weight: male ≥50kg, female ≥45kg, 19≤BMI≤26 (BMI= weight (kg)/height 2 (m2));
4. Pass the comprehensive health examination: vital signs, physical examination, blood urine routine, blood pregnancy, blood glucose, blood lipid, blood electrolyte, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody test, 12-lead electrocardiogram, nicotine, urine drug screening, alcohol breath test, abdominal B-ultrasound, chest X-ray examination, etc., no abnormalities or abnormalities have no clinical significance;
5. Before participating in the study, have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial, and voluntarily participate in this clinical trial, can communicate well with the investigators, comply with the requirements of the entire study, and have the ability to understand and sign the written informed consent.

Exclusion Criteria:

* Volunteers who meet one of the following conditions are not eligible for this study:

  1. Participants in any other clinical trial within three months prior to the trial;
  2. Serum ALT \> upper limit of normal (ULN), AST \> Upper limit of normal (ULN), TBil \> upper limit of normal (ULN);
  3. (Inquiry) Are there any underlying liver diseases, such as chronic hepatitis B, chronic hepatitis C, alcoholic liver disease, moderate to severe non-alcoholic fatty liver disease, liver cirrhosis, etc.;
  4. (Consultation) Have any disease that may affect the safety of the trial or the process of the drug in vivo, including but not limited to: Heart, liver, kidney, endocrine, digestive, immune, respiratory, nervous or psychiatric systems, or other pre-existing or existing diseases of the above systems \[especially cardiovascular disease including those at risk for cardiovascular disease, any gastrointestinal disease that interferes with drug absorption (e.g. symptoms of irritable bowel syndrome, history of inflammatory bowel disease), active pathological bleeding (e.g. peptic ulcer), urticaria, epilepsy, epilepsy, etc. Sensitive rhinitis, eczematous dermatitis, asthma, active pulmonary tuberculosis, etc.
  5. (Consultation) Allergy: If there is a history of drug, food allergy or skin allergy;
  6. (Interview) Any drug that inhibits or induces liver metabolism of the drug in the 28 days prior to the use of the study drug (common liver enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminomide, grofulvin, methylaminopropyl, phenytoin, Grumette, rifampin, dexamethasone; Common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide);

Where this trial is running

Hubei, Wuhan

• Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology — Hubei, Wuhan, China (Recruiting)

Study contacts

• Study coordinator: shaojun Shi, Dr

Conditions Pulmonary Hypertension; Pulmonary hypertension; F230