Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1163-1813 | Registry Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the effect of antacid administration, and its timing, on the bioavailability of a single dose of febuxostat extended-release (XR) 80 mg.
The drug being tested in this study is called febuxostat extended-release (XR). Febuxostat XR is being tested to assess if antacids affect how the drug moves throughout the body. This study will look at lab safety and side effects in people who take febuxostat XR.
This cross-over study will enroll approximately 36 patients. Participants will be randomly assigned to one of four treatment sequences. All participants will receive the following study medications by the end of the study:
All participants will be administered one dose of one or both of the study medications on Day 1 of four separate study periods.
This single-centre trial will be conducted in the United States. The overall time to participate in this study is up to 84 days. Participants will make 5 visits to the clinic including four 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: ABDC | Experimental | Experimental: Sequence 1: ABDC Febuxostat 80 mg extended-release (XR) capsule, orally, once, after a 10-hour fast, and 20 mL Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL (hereafter referred as Maalox) or equivalent, orally, once, after a 10-hour fast, on Day 1 of Period 1 (A), followed by a 7-day washout period, followed by Maalox or equivalent, orally, once, after a 9-hour fast, and febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast (1 hour after Maalox or equivalent), on Day 1 of Period 2 (B), followed by a 7-day washout period, followed by febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, on Day 1 of Period 3 (D), followed by a 7-day washout period, followed by febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, and Maalox or equivalent, orally, once, after an 11-hour fast (1 hour after febuxostat), on Day 1 of Period 4 (C). |
|
| Sequence 2: DACB | Experimental | Experimental: Sequence 2: DACB Febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, on Day 1 of Period 1, followed by a 7-day washout period, followed by febuxostat 80 mg extended-release (XR) capsule, orally, once, after a 10-hour fast, and Maalox or equivalent, orally, once, after a 10-hour fast, on Day 1 of Period 2, followed by a 7-day washout period, followed by febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, and Maalox or equivalent, orally, once, after an 11-hour fast (1 hour after febuxostat), on Day 1 of Period 3, followed by a 7-day washout period, followed by Maalox or equivalent, orally, once, after a 9-hour fast, and febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast (1 hour after Maalox or equivalent), on Day 1 of Period 4. |
|
| Sequence 3: CDBA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Febuxostat XR | Drug | Febuxostat extended-release (XR) capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for Febuxostat | Days 1 at multiple timepoints (up to 48 hours) post-dose | |
| AUC(0-tau): Area Under the Plasma Concentration-time Curve During the Dosing Interval for Febuxostat | Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose | |
| AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat | Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose | |
| Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods) | |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods) | |
| Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings | Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods) | |
| Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Evaluation | Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods) | |
| Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) | Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Any participant who meets any of the following criteria will not qualify for entry into the study:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | 78744 | United States |
Healthy participants were enrolled in this 4 period cross over study to receive 4 regimens which included febuxostat extended release (XR) 80 milligram (mg) and Maalox suspension 20 milliliter (mL) based on different fasting conditions.
Participants took part in the study at 1 investigative site in United States from 23-Feb-15 to 04-May-15.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Regimen A, Then B, Then D, Then C | Regimen(Reg)A(Febuxostat XR 80mg,capsule, orally, single dose after a 10hour(hr) fast and concurrently with Maalox 20mL(200mg magnesium hydroxide, 200mg aluminum hydroxide, and 20mg simethicone/5mL)or equivalent brand antacid, suspension, orally, single dose) on Day1 of first intervention period(3 Days),followed by 1week washout period, followed by RegB(Maalox 20mL,suspension,orally, single dose after a 9hr fast,followed by Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast[or 1hr after antacid dose]) on Day1 of second intervention period(3Days),followed by 1 week washout period, followed by RegD(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast) on Day 1 of third intervention period(3Days),followed by 1week washout period, followed by RegC(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast followed by Maalox 20mL, suspension, orally, single dose after 11hr fast[or 1hr after Febuxostat dose]) on Day1 of fourth intervention period(3 Days). |
| FG001 | Regimen D, Then A, Then C, Then B | Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of first intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of third intervention period (3 Days), followed by 1 week washout period, followed by Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]). |
| FG002 | Regimen C, Then D, Then B, Then A | Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of third intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of fourth intervention period (3 Days). |
| FG003 | Regimen B, Then C, Then A, Then D | Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of second intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of third intervention period (3 Days), Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of fourth intervention period (3 Days). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period 1 (3 Days) |
| |||||||||||||
| Washout Period 1 (7 Days) |
| |||||||||||||
| Intervention Period 2 (3 Days) |
| |||||||||||||
| Washout Period 2 (7 Days) |
| |||||||||||||
| Intervention Period 3 (3 Days) |
| |||||||||||||
| Washout Period 3 (7 Days) |
| |||||||||||||
| Intervention Period 4 (3 Days) |
|
The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Regimen A, Then B, Then D, Then C | Regimen(Reg)A(Febuxostat XR 80mg,capsule, orally, single dose after a 10hour(hr) fast and concurrently with Maalox 20mL(200mg magnesium hydroxide, 200mg aluminum hydroxide, and 20mg simethicone/5mL)or equivalent brand antacid, suspension, orally, single dose) on Day1 of first intervention period(3 Days),followed by 1week washout period, followed by RegB(Maalox 20mL,suspension,orally, single dose after a 9hr fast,followed by Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast[or 1hr after antacid dose]) on Day1 of second intervention period(3Days),followed by 1 week washout period, followed by RegD(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast) on Day 1 of third intervention period(3Days),followed by 1week washout period, followed by RegC(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast followed by Maalox 20mL, suspension, orally, single dose after 11hr fast[or 1hr after Febuxostat dose]) on Day1 of fourth intervention period(3 Days). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax: Maximum Observed Plasma Concentration for Febuxostat | The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Days 1 at multiple timepoints (up to 48 hours) post-dose |
|
Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regimen A | Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, and Maalox or equivalent, orally, once, after an 11-hour fast (1 hour after febuxostat), on Day 1 of Period 1, followed by a 7-day washout period, followed by febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, on Day 1 of Period 2, followed by a 7-day washout period, followed by Maalox or equivalent, orally, once, after a 9-hour fast, and febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast (1 hour after Maalox or equivalent), on Day 1 of Period 3, followed by a 7-day washout period, followed by Febuxostat 80 mg extended-release (XR) capsule, orally, once, after a 10-hour fast, and Maalox or equivalent, orally, once, after a 10-hour fast, on Day 1 of Period 4. |
|
| Sequence 4: BCAD | Experimental | Maalox or equivalent, orally, once, after a 9-hour fast, and febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast (1 hour after Maalox), on Day 1 of Period 1, followed by a 7-day washout period, followed by febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, and Maalox or equivalent, orally, once, after an 11-hour fast (1 hour after febuxostat), on Day 1 of Period 2, followed by a 7-day washout period, followed by febuxostat 80 mg extended-release (XR) capsule, orally, once, after a 10-hour fast, and Maalox or equivalent, orally, once, after a 10-hour fast, on Day 1 of Period 3, followed by a 7-day washout period, followed by febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, on Day 1 of Period 4. |
|
| Maalox Advance Regular Strength liquid | Drug | Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Regimen D, Then A, Then C, Then B | Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of first intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of third intervention period (3 Days), followed by 1 week washout period, followed by Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]). |
| BG002 | Regimen C, Then D, Then B, Then A | Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of third intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of fourth intervention period (3 Days). |
| BG003 | Regimen B, Then C, Then A, Then D | Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of second intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of third intervention period (3 Days), Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of fourth intervention period (3 Days). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Smoking classification | Number | participants |
|
| Alcohol classification | Number | participants |
|
| Xanthine/caffeine consumption | Number | participants |
|
| Female reproductive status | Number | participants |
|
| OG002 | Regimen C | Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods. |
| OG003 | Regimen D | Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods. |
|
|
| Primary | AUC(0-tau): Area Under the Plasma Concentration-time Curve During the Dosing Interval for Febuxostat | The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration. | Posted | Mean | Standard Deviation | nanogram*hour per milliliter (ng*hr/mL) | Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose |
|
|
|
| Primary | AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat | The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration. | Posted | Mean | Standard Deviation | ng*hr/mL | Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose |
|
|
|
| Primary | Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | participants | Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods) |
|
|
|
| Primary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | participants | Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods) |
|
|
|
| Primary | Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings | The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | participants | Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods) |
|
|
|
| Primary | Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Evaluation | The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | participants | Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods) |
|
|
|
| Primary | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) | The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | participants | Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods) |
|
|
|
| 0 |
| 36 |
| 2 |
| 36 |
| EG001 | Regimen B | Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods. | 0 | 36 | 1 | 36 |
| EG002 | Regimen C | Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods. | 0 | 35 | 3 | 35 |
| EG003 | Regimen D | Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods. | 0 | 36 | 2 | 36 |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Oral herpes | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| SAE |
|