Clinical trial NCT01130844: Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcerative Colitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 52
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State
timeFrame: 2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
measure: Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State
timeFrame: Over a 24-hour period starting on day 7
measure: Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State
timeFrame: Over a 24-hour period starting on day 7
measure: Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State
timeFrame: Over a 24-hour period starting on day 7
measure: AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
timeFrame: 2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
measure: Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
timeFrame: Over a 24-hour period starting on day 7
measure: Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
timeFrame: Over a 24-hour period starting on day 7
measure: CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
timeFrame: Over a 24-hour period starting on day 7
Secondary outcomes:
measure: Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State
timeFrame: Over a 24-hour period starting on day 7
measure: Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State
timeFrame: Over a 24-hour period starting on day 7
measure: Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State
timeFrame: Over a 24-hour period starting on day 7
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Baltimore
country: United States
facility: University of Maryland Medical Center for Children
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Parkville
country: Australia
facility: Royal Children's Hospital Melbourne
state: Victoria
city: Wieliczka
country: Poland
facility: Klinika Pediatrii Gastroenterologii i Zywienia, Uniwersytecki Szpital Dzieciecy w Krakowie
state: Krakow
city: Lodz
country: Poland
facility: Klinika Gastroenterolofii Pediatrii, Instytut Centrum Zdrowia Matki Polki
city: Lublin
country: Poland
facility: Klinika Pediatrii Dzieciecy Szpital Kliniczny im prof Antoniego Gebali
city: Rzeszow
country: Poland
facility: Kliniczny Oddzial Pediatrii z Pododdzialem Neurologii Dzieciecej Szpital Wojewodzki
city: Warszawa
country: Poland
facility: Oddzial Gastroenterologii i Hepatologii, Instytut Pomnik-Centrum Zdrowia Dziecka
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
state: Kollarova 2
city: Banska Bystrica
country: Slovakia
facility: DFNsP Banska Bystrica
city: Bratislava
country: Slovakia
facility: Gastroenterologicka ambulancia
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's NHS Foundation Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust/Royal London Hospital
city: London
country: United Kingdom
facility: Somers Clinical Research Facility/Great Ormond Street Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Cuffari C, Pierce D, Korczowski B, Fyderek K, Van Heusen H, Hossack S, Wan H, Edwards AY, Martin P. Randomized clinical trial: pharmacokinetics and safety of multimatrix mesalamine for treatment of pediatric ulcerative colitis. Drug Des Devel Ther. 2016 Feb 4;10:593-607. doi: 10.2147/DDDT.S95316. eCollection 2016.