Phase 1, Febuxostat XR Relative Bioavailability Study

NCT02504320 | Completed Phase 1 Results

• 2 other identifiers: Febuxostat XR-1011U1111-1168-1117
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the relative bioavailability, safety and tolerability following administration of 80 mg single oral doses of 4 febuxostat extended release (XR) formulations.

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (3)

• Mean Cmax: Maximum Observed Plasma Concentration for Febuxostat

  Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

• Mean AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Febuxostat

  AUCt is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration.

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

• Mean AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat

  AUC∞ is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.

  Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

Study Arms (4)

Treatment Sequence ABDC

EXPERIMENTAL

Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).

Drug: Febuxostat XR 80 mg Capsule F1; Drug: Febuxostat XR 80 mg Capsule F2; Drug: Febuxostat XR 80 mg Capsule F3; Drug: Febuxostat XR 80 mg Capsule F4

Treatment Sequence DACB

EXPERIMENTAL

Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).

Drug: Febuxostat XR 80 mg Capsule F1; Drug: Febuxostat XR 80 mg Capsule F2; Drug: Febuxostat XR 80 mg Capsule F3; Drug: Febuxostat XR 80 mg Capsule F4

Treatment Sequence CDBA

EXPERIMENTAL

Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).

Drug: Febuxostat XR 80 mg Capsule F1; Drug: Febuxostat XR 80 mg Capsule F2; Drug: Febuxostat XR 80 mg Capsule F3; Drug: Febuxostat XR 80 mg Capsule F4

Treatment Sequence BCAD

EXPERIMENTAL

Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).

Drug: Febuxostat XR 80 mg Capsule F1; Drug: Febuxostat XR 80 mg Capsule F2; Drug: Febuxostat XR 80 mg Capsule F3; Drug: Febuxostat XR 80 mg Capsule F4

Interventions

Febuxostat XR 80 mg Capsule F1 DRUG

Febuxostat extended-release (XR) capsules formulation 1

Treatment Sequence ABDC; Treatment Sequence BCAD; Treatment Sequence CDBA; Treatment Sequence DACB

Febuxostat XR 80 mg Capsule F2 DRUG

Febuxostat XR capsules formulation 2

Treatment Sequence ABDC; Treatment Sequence BCAD; Treatment Sequence CDBA; Treatment Sequence DACB

Febuxostat XR 80 mg Capsule F3 DRUG

Febuxostat XR capsules formulation 3

Treatment Sequence ABDC; Treatment Sequence BCAD; Treatment Sequence CDBA; Treatment Sequence DACB

Febuxostat XR 80 mg Capsule F4 DRUG

Febuxostat XR capsules formulation 4

Treatment Sequence ABDC; Treatment Sequence BCAD; Treatment Sequence CDBA; Treatment Sequence DACB

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
• Is a healthy male or female and aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
• Weighs at least 50.0 kg and has a body mass index (BMI) from 18.0 to 30.0 kg/m2, inclusive at Screening.
• A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose.
• A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent,
• Is willing to refrain from strenuous exercise from Day -1 of Period 1 until Study Exit (Day 3 of Period 4).
• Has estimated glomerular filtration rate (eGFR) ≥90 mL/min at Screening and Check-in (Day -1 of Period 1).

You may not qualify if:

• Has received any investigational compound within 30 days prior to the first dose of study medication.
• Has received febuxostat in a previous clinical study or as a therapeutic agent.
• Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study.
• Has uncontrolled, clinically significant (CS) disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
• Has a known hypersensitivity to any component of the formulation of XO inhibitors, xanthine compounds, caffeine, or any component of the formulation of febuxostat capsules.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

F 4

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  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: July 20, 2015
• First Posted: July 21, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 19, 2017
• Results First Posted: January 19, 2017

Record last verified: 2016-11

Locations

US (1)