RDEA3170 Tablet and Capsule Bioavailability Study

NCT02448368 | Completed Phase 1 Results FDA Drug

• 1 other identifier: RDEA3170-111
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• Maximum Observed Plasma Concentration (Cmax)

  Cmax is the maximum observed concentration of a drug after administration

  Day 1, 5, 9, 13, 17

• Time of Occurrence of Maximum Observed Concentration (Tmax)

  Tmax is the time of occurrence of cmax

  Day 1, 5, 9, 13, 17

• Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)

  AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint

  Day 1, 5, 9, 13, 17

• Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)

  AUC 0-∞ is a meausre of total concentration from time zero to infinity

  Day 1, 5, 9, 13, 17

• Apparent Terminal Half-life (t1/2)

  t1/2 is a measure of apparent terminal half-life

  Day 1, 5, 9, 13, 17

• Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules

  Cmax is the maximum observed concentration of a drug after administration

  Day 1, 5, 9, 13, 17

• AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules

  AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint

  Day 1, 5, 9, 13, 17

• AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules

  AUC 0-∞ is a meausre of total concentration from time zero to infinity

  Day 1, 5, 9, 13, 17

Secondary Outcomes (2)

• Pharmacodynamics (PD) Profile of RDEA3170

  Day -1, 1, 5, 9, 13, 17

• Incidence of Treatment-Emergent Adverse Events

  8 weeks

Study Arms (8)

Treatment A

EXPERIMENTAL

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

Drug: RDEA3170, 5 mg

Treatment B

EXPERIMENTAL

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

Drug: RDEA3170, 5 mg

Treatment C

EXPERIMENTAL

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

Drug: RDEA3170,10 mg

Treatment D

EXPERIMENTAL

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

Drug: RDEA3170,10 mg

Treatment E

EXPERIMENTAL

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

Drug: RDEA3170, 2.5 mg

Treatment I

EXPERIMENTAL

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

Drug: RDEA3170, 10 mg

Treatment J

EXPERIMENTAL

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

Drug: RDEA3170, 10 mg

Treatment K

EXPERIMENTAL

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

Drug: RDEA3170, 2.5 mg

Interventions

RDEA3170,10 mg 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.

Also known as: Cohort 1

Treatment C; Treatment D

RDEA3170, 2.5 mg 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.

Also known as: Cohort 1

Treatment E

RDEA3170, 5 mg 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.

Also known as: Cohort 1

Treatment A; Treatment B

RDEA3170, 10 mg DRUG

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

Also known as: Cohort 3

Treatment I; Treatment J

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (1)

Unknown Facility

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

verinurad

Results Point of Contact

• Title: Jesse Hall, MD
• Organization: Ardea Biosciences, Inc.

JHall@ardeabio.com

(858) 652-6672

Study Officials

• J Hall, MD

  Ardea Biosciences, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 19, 2015
• Study Start: May 1, 2015
• Primary Completion: June 26, 2015
• Study Completion: January 29, 2016
• Last Updated: August 20, 2018
• Results First Posted: August 20, 2018

Record last verified: 2017-11

Locations

US (1)