NCT07476963

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Forward Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

A Phase I, single-center, open-label, randomized, single-dose, three-period crossover study conducted in Chinese healthy subjects to evaluate the effect of high-fat and low-fat meals on the pharmacokinetics of FWD1802. A total of 18 healthy subjects are planned to be enrolled. Subjects will be randomly assigned in a 1:1:1 ratio to one of three sequences. Each sequence consists of three cycles, with one dose administered per cycle, and a washout period of ≥14 days between consecutive doses. The three sequences are as follows: Sequence 1: Cycle 1 - administration under fasting conditions; Cycle 2 - administration after a low-fat meal; Cycle 3 - administration after a high-fat meal. Sequence 2: Cycle 1 - administration after a low-fat meal; Cycle 2 - administration after a high-fat meal; Cycle 3 - administration under fasting conditions. Sequence 3: Cycle1 - administration after a high-fat meal; Cycle 2 - administration under fasting conditions; Cycle 3 - administration after a low-fat meal. Notes: 1. Fasting Condition (Reference): A single dose of 150 mg FWD1802 is taken orally after fasting for at least 10 hours (water is allowed as needed). 2. Low-Fat Meal: A single dose of 150 mg FWD1802 is taken orally after a low-fat meal. 3. High-Fat Meal: A single dose of 150 mg FWD1802 is taken orally after a high-fat meal. 4. Low-Fat Meal: Total calories approximately 400-500 Kcal, with fat constituting approximately 25% of the total caloric content. 5. High-Fat Meal: A high-calorie (approximately 800-1000 Kcal) and high-fat meal (fat constituting approximately 50% of the total caloric content), with approximately 150, 250, and 500-600 Kcal derived from protein, carbohydrates, and fat, respectively. The composition of the high-fat and low-fat meals must be consistent across all cycles.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	FWD1802	Single-dose of 150 mg of FWD1802.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: China