RDEA3170 Tablet and Capsule Bioavailability Study

Ardea Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: RDEA3170, 5 mg; Drug: RDEA3170,10 mg; Drug: RDEA3170, 2.5 mg; Drug: RDEA3170, 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02448368

RDEA3170-111

Details and patient eligibility

About

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

Enrollment: 35 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 of 4 to 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 within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1.
• Subject has clinically unacceptable physical examination, per the Investigator's judgment.
• Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment.
• Subject has Screening clinical safety laboratory parameters (serum chemistry [other than serum creatinine and serum urate], hematology, coagulation or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator.
• Subject has a serum creatinine value above the upper limit of normal at the Screening visit.
• Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment.
• Subject has a history of cardiac abnormalities
• Subject cannot swallow multiple tablets or capsules.
• Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 8 patient groups

Treatment A

Experimental group

Description:

RDEA3170, 5 mg (FN24), administered in the fasted state.

Treatment:

Drug: RDEA3170, 5 mg

Treatment B

Experimental group

Description:

RDEA3170, 5 mg (FN24), administered in the fed state (high-fat, high-calorie meal).

Treatment:

Drug: RDEA3170, 5 mg

Treatment C

Experimental group

Description:

RDEA3170, 10 mg (FN25), administered in the fasted state.

Treatment:

Drug: RDEA3170,10 mg

Treatment D

Experimental group

Description:

RDEA3170, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal).

Treatment:

Drug: RDEA3170,10 mg

Treatment E

Experimental group

Description:

RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.

Treatment:

Drug: RDEA3170, 2.5 mg

Drug: RDEA3170, 2.5 mg

Treatment I

Experimental group

Description:

RDEA3170, 10 mg (FN26), administered in the fasted state.

Treatment:

Drug: RDEA3170, 10 mg

Treatment J

Experimental group

Description:

RDEA3170, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).

Treatment:

Drug: RDEA3170, 10 mg

Treatment K

Experimental group

Description:

RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.

Treatment:

Drug: RDEA3170, 2.5 mg

Drug: RDEA3170, 2.5 mg