Evaluation of the Food Effecton the Pharmacokinetics of FWD1802 in Healthy Subjects

NCT07476963 | Active Not Recruiting Phase 1

• 1 other identifier: FWD1802-FE
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I, Single-Center, Open-Label, Randomized, Single-Dose, Three-Period Crossover Study to Evaluate the Effect of High-Fat and Low-Fat Meals on the Pharmacokinetics of FWD1802 in Chinese Healthy Subjects. The primary objectives are to address the following questions: To evaluate the impact of high-fat and low-fat meals on the pharmacokinetic (PK) characteristics of a single oral dose of FWD1802 in healthy Chinese Subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  Peak Plasma Concentration (Cmax) of FWD1802

  240 hours

• Area under the plasma concentration versus time curve (AUC0-t)

  Area under the plasma concentration versus time curve (AUC) from time zero to the last quantifiable time point of FWD1802

  240 hours

• Area under the plasma concentration versus time curve (AUC0-∞)

  Area under the plasma concentration versus time curve from time zero extrapolated to infinity of FWD1802

  240 hours

Secondary Outcomes (11)

• Time to Peak Concentration (Tmax)

  240 hours

• Percentage of the area under the plasma concentration-time curve from time 0 extrapolated to infinity

  240 hours

• Absorption lag time (t lag)

  240 hours

• Half-life (t₁/₂)

  240 hours

• Apparent clearance (CL/F)

  240 hours

Study Arms (3)

Sequence 1

EXPERIMENTAL

Enrolled subjects will be administered the study drug under fasting conditions (fasted for at least 10 hours, with water allowed as needed) on Day 1 of Cycle 1, followed by a follow-up period and the washout period. They will then proceed to Cycle 2, where the study drug will be administered on Day 1 after consuming a low-fat meal (total calories approximately 400-500 Kcal, with fat constituting approximately 25% of the total caloric content), again followed by a follow-up period and the washout period. Subsequently, in Cycle 3, the study drug will be administered on Day 1 after consuming a high-calorie (approximately 800-1000 Kcal) and high-fat meal (fat constituting approximately 50% of the total caloric content), followed by the final follow-up period.

Drug: FWD1802

Sequence 2

EXPERIMENTAL

Enrolled subjects will be administered the study drug on Day 1 of Cycle 1 after consuming a low-fat meal (total calories approximately 400-500 Kcal, with fat constituting approximately 25% of the total caloric content), followed by a follow-up period and the washout period. They will then proceed to Cycle 2, where the study drug will be administered on Day 1 after consuming a high-calorie (approximately 800-1000 Kcal) and high-fat meal (fat constituting approximately 50% of the total caloric content), again followed by a follow-up period and the washout period. Subsequently, in Cycle 3, the study drug will be administered on Day 1 under fasting conditions (fasted for at least 10 hours, with water allowed as needed), followed by the final follow-up period.

Drug: FWD1802

Sequence 3

EXPERIMENTAL

Enrolled subjects will be administered the study drug on Day 1 of Cycle 1 after consuming a high-calorie (approximately 800-1000 Kcal) and high-fat meal (fat constituting approximately 50% of the total caloric content), followed by a follow-up period and the washout period. They will then proceed to Cycle 2, where the study drug will be administered on Day 1 under fasting conditions (fasted for at least 10 hours, with water allowed as needed), again followed by a follow-up period and the washout period. Subsequently, in Cycle 3, the study drug will be administered on Day 1 after consuming a low-fat meal (total calories approximately 400-500 Kcal, with fat constituting approximately 25% of the total caloric content), followed by the final follow-up period.

Drug: FWD1802

Interventions

FWD1802 DRUG

Single-dose of 150 mg of FWD1802.

Sequence 1; Sequence 2; Sequence 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject understands the trial's objectives, nature, methods, and potential adverse reactions, voluntarily participates, and signs the informed consent form, ensuring that all trial procedures will be personally undertaken by the subject.
• Chinese male or female subjects, aged 18-45 years (inclusive) for males and 18-50 years (inclusive) for females at the time of screening.
• Body mass index (BMI) between 19.0 and 28.0 kg/m² (inclusive); body weight ≥50.0 kg for males and ≥45.0 kg for females.
• Results from screening assessments, including medical history inquiry, vital signs \[body temperature (tympanic), pulse, blood pressure (seated)\], comprehensive physical examination, laboratory tests (complete blood count, blood chemistry, urinalysis, coagulation function), 12-lead electrocardiogram (ECG), abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidneys), and chest X-ray (posteroanterior view), are all within normal limits or show abnormalities that are not clinically significant.
• Female subjects have no pregnancy plan and voluntarily agree to use effective contraceptive measures (Appendix 1) from 2 weeks prior to the first dose until 6 months after the last dose / Male subjects have no pregnancy plan for their partners and voluntarily agree to use effective contraceptive measures (Appendix 1) from the first dose until 6 months after the last dose, with no plans for sperm or egg donation.

You may not qualify if:

• History of severe allergies (including allergic constitution, drug allergies, allergies to two or more types of food, etc.) or known hypersensitivity to FWD1802 and/or any of its excipients.
• Special dietary requirements or inability to tolerate a high-calorie (approximately 800-1000 Kcal per meal) and high-fat (fat constituting approximately 50% of total caloric intake) diet.
• History of dysphagia or any gastrointestinal disease that may affect drug absorption (including but not limited to gastrointestinal dysfunction, total/partial gastrectomy, gastrointestinal bleeding/ulcer, malabsorption syndrome, uncontrolled nausea/vomiting/diarrhea, etc.).
• Undergone surgery within 3 months prior to screening or planned surgery during the study period.
• Intolerance to venipuncture, history of needle phobia/blood phobia, or difficulty with blood collection.
• History of drug abuse or positive urine drug abuse screening (at baseline).
• Regular alcohol consumption exceeding 21 units per week within 3 months prior to screening (1 unit = 360 mL of beer, 150 mL of wine, or 45 mL of 40% spirits) or positive alcohol breath test (at baseline).
• Smoking history of more than 10 cigarettes per day within 3 months prior to screening.
• Excessive consumption of tea, coffee, and/or caffeine-rich beverages (average \>8 cups per day, 1 cup = 250 mL) within 3 months prior to screening.
• Donated blood or experienced significant blood loss (≥400 mL), or received blood transfusion or blood products within 3 months prior to the first dose.
• Participation in another clinical trial involving an investigational drug and receipt of the study drug within 3 months prior to the first dose, with an interval less than 5 half-lives of the previously administered drug.
• Use of any moderate/strong CYP3A4 inhibitors or inducers, P-glycoprotein (P-gp) inhibitors, or drugs that suppress gastric acid production (e.g., proton pump inhibitors, PPIs) within 28 days prior to the first dose (refer to Table 3 for CYP3A4 and P-gp inhibitors/inducers and PPI inhibitors).
• Use of prescription drugs, over-the-counter medications, dietary supplements, or herbal medicines within 14 days prior to the first dose.
• Consumption of chocolate, any food or beverage containing caffeine or xanthine, grapefruit, or grapefruit-related citrus fruits (e.g., pomelo) or juices within 48 hours prior to dosing in each cycle.
• Positive screening result for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody; or history of active or latent tuberculosis (TB).

Sponsors & Collaborators

• Forward Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Study Officials

• Yanmei Liu

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 17, 2026
• Study Start: March 15, 2026
• Primary Completion: July 6, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)