Phase 1 N=52 Randomized Other

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

Ulcerative Colitis

Bottom Line

View on ClinicalTrials.gov: NCT01130844 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcome: Primary: Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State — 21411; 46173; 49213 ug*h/L

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: MMX Mesalamine (Drug)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: Shire
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State	21411; 46173; 49213	—
PRIMARY Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State	1884; 3825; 4314	—
PRIMARY Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State	6.00; 8.98; 1.98	—
PRIMARY Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State	6.48; 5.94; 4.95	—
PRIMARY AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State	30942; 58119; 63067	—
PRIMARY Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State	2396; 4113; 4968	—
PRIMARY Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State	9.00; 7.48; 1.98	—
PRIMARY CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State	16.2; 12.2; 10.0	—
SECONDARY Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State	29.4; 27.0; 22.1	—
SECONDARY Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State	162; 298; 235	—
SECONDARY Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State	532; 708; 593	—

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01130844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.