RDEA3170 Bioavailability Study

NCT02336594 | Completed Phase 1 Results

• 1 other identifier: RDEA3170-110
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gout

Outcome Measures

Primary Outcomes (11)

• Maximum Observed Plasma Concentration (Cmax)

  Cmax of RDEA3170 in fasted condition.

  Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

• Time of Occurrence of Maximum Observed Concentration (Tmax)

  Tmax of RDEA3170 following various treatments.

  Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

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

  AUC last of RDEA3170 in fasted condition.

  Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

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

  AUC∞ of RDEA3170 the fasted condition.

  Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

• Apparent Terminal Half-life (t1/2)

  t1/2 of RDEA3170 following various treatments.

  Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

• Cmax: Effect of High Fat Meal on the PK of RDEA3170 Tablets

  Cmax of RDEA3170 in high-fat fed state.

  Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

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

  AUC last of RDEA3170 in high-fat fed state.

  Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

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

  AUC∞ of RDEA3170 in high-fat fed state.

  Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

• Cmax: Effect of Low Fat Meal on the PK of RDEA3170 Tablets

  Cmax of RDEA3170 in low-fat fed state.

  Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

• AUC Last: Effect of Low Fat Meal on the PK of RDEA3170 Tablets

  AUC last of RDEA3170 in low-fat fed state.

  Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

• AUC∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets

  AUC∞ of RDEA3170 in low-fat fed state.

  Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

Secondary Outcomes (2)

• Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine

  Day -1: -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours predose. Days 1, 5, 9, and 13: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose.

• Incidence of Treatment-Emergent Adverse Events

  7 weeks.

Study Arms (4)

Sequence ABCD

EXPERIMENTAL

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.

Drug: RDEA3170 10 mg; Drug: RDEA3170 2.5 mg

Sequence BACD

EXPERIMENTAL

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

Drug: RDEA3170 10 mg; Drug: RDEA3170 2.5 mg

Sequence ABDC

EXPERIMENTAL

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

Drug: RDEA3170 10 mg; Drug: RDEA3170 2.5 mg

Sequence BADC

EXPERIMENTAL

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

Drug: RDEA3170 10 mg; Drug: RDEA3170 2.5 mg

Interventions

RDEA3170 10 mg DRUG

Sequence ABCD; Sequence ABDC; Sequence BACD; Sequence BADC

RDEA3170 2.5 mg DRUG

Sequence ABCD; Sequence ABDC; Sequence BACD; Sequence BADC

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 ≤ 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 (\> 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

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (1)

Unknown Facility

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Gout

Interventions

verinurad

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Jesse Hall, MD
• Organization: Study Information Center AstraZeneca

information.center@astrazeneca.com

+1 877-240-9479

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: November 6, 2014
• First Posted: January 13, 2015
• Study Start: November 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 13, 2017
• Results First Posted: October 13, 2017

Record last verified: 2017-10

Locations

US (1)