RDEA3170 Bioavailability Study

Ardea Biosciences

Status and phase: Completed; Phase 1

Conditions: Gout

Treatments: Drug: RDEA3170 10 mg; Drug: RDEA3170 2.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02336594

RDEA3170-110

Details and patient eligibility

About

This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets) and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity
• Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2
• Subject has a Screening serum urate level ≤ 7 mg/dL
• Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment

Exclusion criteria

• Subject has a history or suspicion of kidney stones
• Subject has undergone major surgery within 3 months prior to Screening
• Subject donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1
• Subject has inadequate venous access or unsuitable veins for repeated venipuncture
• Subject has a Screening serum creatinine value above the upper limit of normal during Screening or at Day -2 (Admission)
• Subject cannot swallow multiple tablets
• Subject is a heavy caffeine drinker
• Subject is unwilling to comply with the dietary restrictions of the study
• Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

Sequence ABCD

Experimental group

Description:

2.5 mg x 4 tablets qd (once daily) fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat.

Treatment:

Drug: RDEA3170 10 mg

Drug: RDEA3170 2.5 mg

Sequence BACD

Experimental group

Description:

10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat

Treatment:

Drug: RDEA3170 10 mg

Drug: RDEA3170 2.5 mg

Sequence ABDC

Experimental group

Description:

2.5 x 4 mg tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat

Treatment:

Drug: RDEA3170 10 mg

Drug: RDEA3170 2.5 mg

Sequence BADC

Experimental group

Description:

10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat

Treatment:

Drug: RDEA3170 10 mg

Drug: RDEA3170 2.5 mg