Food Effect Study of Febuxostat XR in Healthy Participants

Gout Clinical Trial

Official title:

A Phase 1, Open-Label, Single-Center, Randomized, 3-Way Crossover Study to Assess the Effect of Food on the Bioavailability of a Single Oral Dose of 80 mg Febuxostat Extended-Release Formulation and the Pharmacokinetics of a Single Oral Dose of 40 mg and 80 mg Febuxostat Extended-Release Formulation in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374164
• Other study ID #: Febuxostat-XR-1009
• Secondary ID: U1111-1165-0441
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2015
• Last updated: May 20, 2015
• Start date: February 2015
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effect of food on the bio availability of Febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the PK of Febuxostat after single oral doses of 40 and 80 mg Febuxostat XR.

Description:

The drug being tested in this study is called Febuxostat extended- release (XR). This study is evaluating the effect of food on how febuxostat-XR moves throughout the body. This study will also look at the side effects and all safety results in people who took the study drug.

This 3-way crossover study will enroll approximately 36 participants. Eligible participants will be randomly (by chance) assigned to one of the 3 treatment sequences at 1:1:1 ratio. Sequence defines the order in which participants receive Regimens A (Febuxostat XR 80 mg after a high fat meal), B (Febuxostat XR 40 mg after fasting) and C (Febuxostat XR 80 mg after fasting):

Sequence 1: A, B, C

Sequence 2: B, C, A

Sequence 3: C, A, B The dose in a period and the dose in the subsequent period will be separated by a minimum 7-day washout interval. This single-centre trial will be conducted in the United States.

Participants will make 4 visits to the clinic including three 4-day periods of confinement to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Has an estimated glomerular filtration rate =90 mL/min.

2. Weighs at least 50 kg (110 pounds) and has a body mass index (BMI) from 18.0 to 30.0 kg/m^2, inclusive, at Screening.

3. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from the signing of the informed consent throughout the duration of the study and for 30 days after the last dose.

4. 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 throughout the duration of the study and for 30 days after the last dose.

5. Able to attend all the visits scheduled in the study.

6. Willing to refrain from strenuous exercise from Day -1 until Study Exit (Day 3 of Period 3).

Exclusion Criteria:

1. Hypersensitivity to Febuxostat or to any of the components of the formulation.

2. Has received any investigational compound within 30 days prior to the first dose of study medication.

3. Has received febuxostat in a previous clinical study or as a therapeutic agent.

4. Has uncontrolled, clinically significant disease or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results.

5. Has a known hypersensitivity to any XO inhibitor, xanthine compounds, Febuxostat or any component of the formulation of Febuxostat tablets, or to caffeine.

6. Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1 of Period 1).

7. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.

8. Is pregnant or lactating or intending to become pregnant before, during, or within 30 days post last dose; or intending to donate ova during such time period.

9. Intends to impregnate others or donate sperm during the course of this study or for 30 days post last dose.

10. Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma, hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the subject's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking febuxostat XR, or a similar drug in the same class, or a disease that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.

11. Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention [eg, cholecystectomy]).

12. Has a history of cancer, except basal cell carcinoma that has been in remission for at least 5 years prior to Day 1 of Period 1.

13. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or a known history of human immunodeficiency virus infection.

14. Has used nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within 28 days prior to Check-in (Day -1 of Period 1) or is unwilling to agree to abstain from nicotine-containing products. Cotinine test is positive at Screening or Check-in (Day 1 of Period 1).

15. Has poor peripheral venous access.

16. Has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis) or had a transfusion of any blood product within 30 days prior to Day 1 of Period 1.

17. Has a Screening abnormal (clinically significant) ECG.

18. Has abnormal Screening or Day -1 of Period 1 laboratory values that suggest a clinically significant underlying disease or subject with the following lab abnormalities: ALT and/or AST >1.5 x the upper limit of normal.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• Febuxostat XR 40 mg
Febuxostat XR 40 mg tablets orally administered as a single dose.
• Febuxostat XR 80 mg
Febuxostat XR 80 mg tablets orally administered as a single dose.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax: Maximum observed plasma concentration for Febuxostat XR	Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Participant blood samples were collected pre-dose and following a single oral dose.	Day 1 pre-dose and up to multiple timepoints (up to 48 hours) post dose	No
Primary	AUCt: Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration	AUCt is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUCt) Participant blood samples were collected pre-dose and following a single oral dose.	Day 1 pre-dose and up to multiple timepoints (up to 48 hours) post dose	No
Primary	AUCinf: Area Under the Plasma Concentration-time Curve from time 0 to infinity	AUCinf is a measure of total plasma exposure to the drug from time zero extrapolated to infinity. Participant blood samples were collected pre-dose and following a single oral dose.	: Day 1 pre-dose and up to multiple timepoints (up to 48 hours) post dose	No