Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis

Overview

The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.

Full Title of Study: “A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 27, 2013

Interventions

  • Drug: MMX Mesalamine
    • 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
  • Drug: MMX Mesalamine
    • 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
  • Drug: MMX Mesalamine
    • 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.

Arms, Groups and Cohorts

  • Experimental: MMX Mesalamine (30mg/kg)
  • Experimental: MMX Mesalamine (60 mg/kg)
  • Experimental: MMX Mesalamine (100 mg/kg)

Clinical Trial Outcome Measures

Primary Measures

  • Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State
    • Time Frame: 2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
    • AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
  • Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State
    • Time Frame: Over a 24-hour period starting on day 7
    • 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.
  • Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State
    • Time Frame: Over a 24-hour period starting on day 7
    • Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
  • Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State
    • Time Frame: Over a 24-hour period starting on day 7
    • Clearance of a substance from the blood by the kidneys.
  • AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
    • Time Frame: 2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
  • Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
    • Time Frame: Over a 24-hour period starting on day 7
  • Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
    • Time Frame: Over a 24-hour period starting on day 7
  • CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
    • Time Frame: Over a 24-hour period starting on day 7

Secondary Measures

  • Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State
    • Time Frame: Over a 24-hour period starting on day 7
    • The percentage of the dose absorbed was calculated as: 100 x (Xu0-24h 5-ASA + [0.7847* Xu0-24h Ac-5-ASA])/dose, where 0.7847 is the ratio of the molecular weight of 5-ASA (153.14) to the molecular weight of Ac-5-ASA (195.15). Xu0-24h is equal to the cumulative amount recovered in urine in the time interval of 0 to 24 hours.
  • Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State
    • Time Frame: Over a 24-hour period starting on day 7
  • Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State
    • Time Frame: Over a 24-hour period starting on day 7

Participating in This Clinical Trial

Inclusion Criteria

1. Subjects aged 5-17 years, with appropriately obtained informed consent and assent. 2. Subject has a documented history of ulcerative colitis for at least 3 months. 3. Subjects who are currently on 5-ASA or product(s) containing or metabolized to mesalamine must have been on a stable regimen for at least 4 weeks prior to first dose of investigational medicinal product. 4. Subjects who are not currently on a drug regimen, or on a 5-ASA or product containing or metabolized to mesalamine, must have been on a stable regimen for at least 4 weeks prior to first dose at least 4 weeks prior first dose of investigational medicinal product. 5. Body weight of 18kg-82kg inclusive. Exclusion Criteria:

1. Current or recurrent disease (eg cardiovascular, renal, liver, malignancy or other conditions) that could affect the colon, the action, absorption or disposition of the IMP, or clinical or laboratory assessments with the exception of their existing ulcerative colitis. 2. Ulcerative Colitis known to be confined to the rectum (isolated rectal proctitis). 3. Any history of hepatic impairment or moderate to severe renal impairment. 4. The use of systemic or rectal steroids within the last 4 weeks, immunomodulators within the last 6 weeks, biologics within 6 months, antibiotic use within the last 7 days prior to the first dose of investigational medicinal product.

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shire
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Takeda

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