Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01469637 · ClinicalTrials.gov registry record · Phase 1
Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
A Phase 1 study of Healthy, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT01469637: Completed Phase 1 study of Healthy, sponsored by Shire.
NCT01469637 is a Phase 1 study of Healthy that has completed, run by Shire. The registered enrollment target is 44 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01469637, a Phase 1 study of Healthy, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG sulfamethoxazole + MMX placebo
- DRUG Sulfamethoxazole + MMX Mesalazine/mesalamine
Study Locations (1)
Kansas
- PRA Inrernational - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2011-11-07 |
| Est. Completion | 2011-12-20 |
| Phase | Phase 1 |
What the finished NCT01469637 record still lists
NCT01469637 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which sulfamethoxazole + MMX placebo is the first listed.
NCT01469637 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT01469637 about?
NCT01469637 is a clinical study titled "Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine". 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).
What is the current status of trial NCT01469637?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2011-11-07. Estimated completion is 2011-12-20.
What conditions does trial NCT01469637 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01469637?
The interventions under investigation include: sulfamethoxazole + MMX placebo (DRUG), Sulfamethoxazole + MMX Mesalazine/mesalamine (DRUG).
Who is sponsoring clinical trial NCT01469637?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01469637 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01469637's enrollment target sits among peer trials
44 506th of 1090 higher than 570 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
RECRUITING · Phase 1
-
A Study of LY3867070 in Healthy Participants
RECRUITING · Phase 1
-
A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.
RECRUITING · Phase 1
-
Evaluate the Pharmacokinetics, Safety, and Tolerability of NSHO-101 in Healthy Participants
RECRUITING · Phase 1
-
Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Supplementation on Myocardial Glucose Suppression and Timing to Achieve a State of Ketosis Using FDG PET/CT Serial Imaging
RECRUITING · Phase 1
-
A Study of V118E in Healthy Participants (V118E-003)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02323945 · 44 participants · NA
Effects of Breathing Mild Bouts of Low Oxygen on Limb Mobility After Spinal Injury
- NCT03093909 · 44 participants · Phase 1
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
- NCT03104491 · 44 participants · Phase 1
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
- NCT03781765 · 44 participants · Phase 4
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI