Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 35
Healthy volunteers: yes

Brief summary:
The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.

Detailed description:

Arms:
arm 1: RDEA3170, 5 mg (FN24), administered in the fasted state. arm 2: RDEA3170, 5 mg (FN24), administered in the fed state (high-fat, high-calorie meal). arm 3: RDEA3170, 10 mg (FN25), administered in the fasted state. arm 4: RDEA3170, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal). arm 5: RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state. arm 6: RDEA3170, 10 mg (FN26), administered in the fasted state. arm 7: RDEA3170, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal). arm 8: RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.

Interventions: intervention 1: RDEA3170,10 mg intervention 2: RDEA3170, 2.5 mg intervention 3: RDEA3170, 5 mg intervention 4: RDEA3170, 10 mg intervention 5: RDEA3170, 2.5 mg
Intervention descriptions: intervention 1: Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17. intervention 2: Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17. intervention 3: Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17. intervention 4: Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9. intervention 5: Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

Protocol document: