Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • FWD1802

    Drug

    Single-dose of 150 mg of FWD1802.

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: Sequence 1Experimental treatment 1 intervention
Group B: Sequence 2Experimental treatment 1 intervention
Group C: Sequence 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Peak Plasma Concentration (Cmax)

Peak Plasma Concentration (Cmax) of FWD1802

Time frame
240 hours
2

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

Time frame
240 hours
3

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

Time frame
240 hours

Secondary outcomes

1

Time to Peak Concentration (Tmax)

Time to Peak Concentration (Tmax) of FWD1802

Time frame
240 hours
2

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

Percentage of the area under the plasma concentration-time curve from time 0 extrapolated to infinity of FWD1802

Time frame
240 hours
3

Absorption lag time (t lag)

Absorption lag time (t lag) of FWD1802

Time frame
240 hours
4

Half-life (t₁/₂)

Half-life (t₁/₂) of FWD1802

Time frame
240 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Forward Pharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: