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Completed

NCT Number: NCT01130844

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

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royal Children's Hospital Melbourne, Parkville, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects aged 5-17 years, with appropriately obtained informed consent and assent.
  • Subject has a documented history of ulcerative colitis for at least 3 months.
  • 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.
  • 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.
  • Body weight of 18kg-82kg inclusive.

Exclusion criteria

  • 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.
  • Ulcerative Colitis known to be confined to the rectum (isolated rectal proctitis).
  • Any history of hepatic impairment or moderate to severe renal impairment.
  • 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.

Treatment and study plan

MMX Mesalamine

Drug

30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.

Other names: Lialda, SPD476

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State

    Time frame: Over a 24-hour period starting on day 7

  7. Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State

    Time frame: Over a 24-hour period starting on day 7

  8. CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State

    Time frame: Over a 24-hour period starting on day 7

Secondary outcomes

  1. 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.

  2. Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State

    Time frame: Over a 24-hour period starting on day 7

  3. 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

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 26, 2010
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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