Evaluation of the Food Effecton the Pharmacokinetics of FWD1802 in Healthy Subjects
ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorForward Pharmaceuticals Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
History or presence of clinically significant diseases requiring exclusion, including but not limited to disorders of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, gastrointestinal, psychiatric, ophthalmological, respiratory, metabolic, and skeletal systems.
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.).
Trial design
Treatments tested in this trial
- FWD1802
Treatment groups
18 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov