Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole administered alone & in combination with Multi MatriX system (MMX®) formulation of mesalazine/mesalazine (Lialda®; Mesavancol®; Mezavant®) (MMX Mesalazine/mesalamine).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulfamethoxazole + MMX placebo | Experimental |
| |
| Sulfamethoxazole + MMX Mesalazine/mesalamine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sulfamethoxazole + MMX placebo | Drug | 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX Mesalazine/mesalamine placebo once daily (QD) orally for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX Mesalazine/mesalamine placebo orally on Day 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body. | Assessed over a 24-hour period starting post-dose on day 4 |
| Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. | Assessed over a 24-hour period starting post-dose on day 4 |
Not provided
Not provided
Inclusion Criteria:
Age 18-55 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period.
Subject is willing to comply with any applicable contraceptive requirements of the protocol and is:
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Inrernational | Lenexa | Kansas | 66219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24868146 | Derived | Pierce D, Corcoran M, Martin P, Barrett K, Inglis S, Preston P, Thompson TN, Willsie SK. Effect of MMX(R) mesalamine coadministration on the pharmacokinetics of amoxicillin, ciprofloxacin XR, metronidazole, and sulfamethoxazole: results from four randomized clinical trials. Drug Des Devel Ther. 2014 May 14;8:529-43. doi: 10.2147/DDDT.S55373. eCollection 2014. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sulfamethoxazole + MMX Placebo First | 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention. |
| FG001 | Sulfamethoxazole + MMX Mesalazine/Mesalamine First | 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| ||||||||||||||||||
| Second Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sulfamethoxazole + MMX Placebo First | 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention. |
| 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 | Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body. | Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment. | Posted | Mean | Standard Deviation | h*ug/ml | Assessed over a 24-hour period starting post-dose on day 4 |
|
Not provided
Not provided
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 | Sulfamethoxazole + MMX Placebo | 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
Not provided
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sulfamethoxazole + MMX Mesalazine/mesalamine | Drug | 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 |
|
|
| NOT COMPLETED |
|
|
| BG001 | Sulfamethoxazole + MMX Mesalazine/Mesalamine First | 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Sulfamethoxazole + MMX Mesalazine/Mesalamine | 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4. |
|
|
|
| Primary | Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. | Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment. | Posted | Mean | Standard Deviation | ug/ml | Assessed over a 24-hour period starting post-dose on day 4 |
|
|
|
|
| 0 |
| 43 |
| 10 |
| 43 |
| EG001 | Sulfamethoxazole + MMX Mesalazine/Mesalamine | 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4. | 0 | 44 | 14 | 44 |
| Abdominal distension | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Dry mouth | Gastrointestinal disorders |
|
| Flatulence | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Toothache | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Fatigue | General disorders |
|
| Laryngitis | Infections and infestations |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Nervousness | Psychiatric disorders |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
|
| Phlebitis | Vascular 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.
| D013424 |
| Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D010636 | Phenols |