RDEA3170 Tablet and Capsule Bioavailability Study

NCT ID: NCT02448368

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-01
• Study Completion Date: 2016-01-29

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Treatment A

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

Group Type: EXPERIMENTAL

RDEA3170, 5 mg

Intervention Type: DRUG

Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

Treatment B

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

Group Type: EXPERIMENTAL

RDEA3170, 5 mg

Intervention Type: DRUG

Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

Treatment C

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

Group Type: EXPERIMENTAL

RDEA3170,10 mg

Intervention Type: DRUG

Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

Treatment D

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

Group Type: EXPERIMENTAL

RDEA3170,10 mg

Intervention Type: DRUG

Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

Treatment E

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

Group Type: EXPERIMENTAL

RDEA3170, 2.5 mg

Intervention Type: DRUG

Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

Treatment I

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

Group Type: EXPERIMENTAL

RDEA3170, 10 mg

Intervention Type: DRUG

Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

Treatment J

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

Group Type: EXPERIMENTAL

RDEA3170, 10 mg

Intervention Type: DRUG

Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

Treatment K

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

Group Type: EXPERIMENTAL

RDEA3170, 2.5 mg

Intervention Type: DRUG

Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

Interventions

RDEA3170,10 mg

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 Type: DRUG

RDEA3170, 2.5 mg

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 Type: DRUG

RDEA3170, 5 mg

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 Type: DRUG

RDEA3170, 10 mg

Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

Intervention Type: DRUG

RDEA3170, 2.5 mg

Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

Intervention Type: DRUG

Other Intervention Names

Cohort 1; Cohort 1; Cohort 1; Cohort 3; Cohort 3

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ardea Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J Hall, MD

Role: STUDY_DIRECTOR

Ardea Biosciences, Inc.

Locations

Austin, Texas, United States

Countries

United States

Other Identifiers

RDEA3170-111

Identifier Type: -

Identifier Source: org_study_id