RDEA3170 PK/PD Study

Ardea Biosciences

Status and phase: Completed; Phase 1

Conditions: Gout

Treatments: Drug: RDEA3170 4.5 mg; Drug: RDEA3170 12 mg; Drug: RDEA3170 6 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02608710

RDEA3170-112

Details and patient eligibility

About

The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 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 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: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Single Dose

Experimental group

Description:

Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9.

Treatment:

Drug: RDEA3170 4.5 mg

Drug: RDEA3170 6 mg

Drug: RDEA3170 12 mg

Multiple Dose

Experimental group

Description:

RDEA3170 12 mg once daily (qd)

Treatment:

Drug: RDEA3170 12 mg

Single Dose Food Effect

Experimental group

Description:

Since dose of RDEA3170 6 mg administered in fed or fasted state on Day 1 and Day 8.

Treatment:

Drug: RDEA3170 6 mg