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This study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. This study is also being done to assess the safety and tolerability of the two lanthanum carbonate formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lanthanum carbonate granules | Experimental | Lanthanum carbonate granulated formulation crossover to chewable tablet formulation |
|
| Lanthanum carbonate chewable tablets (Fosrenol) | Experimental | Lanthanum carbonate chewable table formulation crossover to granulated formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanthanum carbonate Granule Formulation | Drug | 3x's per day for 3 days, 1 dose in the am for day 4. (A single dose equals 1000mg of lanthanum carbonate granule formulation. Dose is administered immediately after each meal.) |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Phosphate Excretion 3-Day Average | Continuous collection over 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Phosphate Excretion on Day 4 | Continuous collection on Day 4 | |
| Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate | 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials, LLC | Cypress | California | 90630 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22657252 | Result | Pierce D, Hossack S, Robinson A, Zhang P, Martin P. Assessment of pharmacodynamic equivalence and tolerability of lanthanum carbonate oral powder and tablet formulations: a single-center, randomized, open-label, 2-period crossover study in healthy subjects. Clin Ther. 2012 Jun;34(6):1290-1300.e2. doi: 10.1016/j.clinthera.2012.05.003. Epub 2012 May 31. |
| Label | URL |
|---|---|
| FDA recall information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lanthanum Carbonate Granules First | Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4. |
| FG001 | Lanthanum Carbonate Chewable Tablet First | Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| |||||||||||||||||||||
| Washout Period |
| ||||||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lanthanum Carbonate Granules First | Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Urinary Phosphate Excretion 3-Day Average | Pharmacodynamic Set (PD) includes all subjects who completed all urine collections and consumed at least 95% of food in all treatment periods. Subjects who vomited from days -2 to 4 of any treatment period were excluded from the set. | Posted | Least Squares Mean | Standard Error | mmol | Continuous collection over 3 days |
|
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Safety set (SS) consists of subjects who received at least 1 dose of the investigational medicinal product and had at least 1 post-dose safety assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lanthanum Carbonate Granules | Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
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| Lanthanum carbonate Chewable Tablets (Fosrenol) | Drug | 3x's per day for 3 days, 1 dose on day 4. (A single dose equals a 1000mg tablet of lanthanum carbonate. Dose is administered immediately after each meal.) |
|
|
| Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate | 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4 |
| Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate | 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4 |
| Non-compliance with meals |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| Lanthanum Carbonate Chewable Tablet First |
Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | Urinary Phosphate Excretion on Day 4 | PD set | Posted | Least Squares Mean | Standard Error | mmol | Continuous collection on Day 4 |
|
|
|
|
| Secondary | Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate | Pharmacokinetic set (PK) includes all subjects who had sufficient post-dose blood samples taken to estimate Cmax and AUC 0-48 hours after dosing on Day 4 in all treatment periods. Subjects who vomited between dosing and 10 hours post-dose on Day 4 of any treatment period were excluded from the PK set. | Posted | Mean | Standard Deviation | ng*h/ml | 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4 |
|
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate | PK set | Posted | Mean | Standard Deviation | ng/ml | 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4 |
|
|
|
|
| Secondary | Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate | PK set | Posted | Median | Full Range | hours | 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4 |
|
|
|
|
| 0 |
| 71 |
| 9 |
| 71 |
| EG001 | Lanthanum Carbonate Chewable Tablet | Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4 | 0 | 61 | 6 | 61 |
| Headache | Nervous system disorders |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |