Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05002231 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability and Food Effect Study of Losmapimod 15 mg Tablets
A Phase 1 study, sponsored by Fulcrum Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT05002231: Completed Phase 1 study, sponsored by Fulcrum Therapeutics.
NCT05002231 is a Phase 1 study that has completed, run by Fulcrum Therapeutics. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05002231, a Phase 1 study, has completed, sponsored by Fulcrum Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a study to assess the relative bioavailability and the effect of food on the pharmacokinetics of a new 15 mg tablet formulation of losmapimod
Primary Outcome
To assess the bioavailability of losmapimod (1 x 15 mg tablet) (test) versus losmapimod tablets (2 x 7.5 mg tablets) (reference), blood samples will be collected under fasted conditions to measure the plasma concentration of losmapimod at specified timepoints by liquid chromatography with tandem mass spectrometry.
Interventions
- DRUG Losmapimod 15 mg oral tablet
- DRUG Losmapimod two 7.5 mg oral tablets
- DRUG Losmapimod one 15 mg oral tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-08-19 |
| Est. Completion | 2021-10-22 |
| Phase | Phase 1 |
What the finished NCT05002231 record still lists
NCT05002231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Losmapimod 15 mg oral tablet is the first listed.
NCT05002231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05002231 about?
NCT05002231 is a clinical study titled "Relative Bioavailability and Food Effect Study of Losmapimod 15 mg Tablets". This is a study to assess the relative bioavailability and the effect of food on the pharmacokinetics of a new 15 mg tablet formulation of losmapimod
What is the current status of trial NCT05002231?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2021-08-19. Estimated completion is 2021-10-22.
What interventions are being tested in trial NCT05002231?
The interventions under investigation include: Losmapimod 15 mg oral tablet (DRUG), Losmapimod two 7.5 mg oral tablets (DRUG), Losmapimod one 15 mg oral tablet (DRUG).
Who is sponsoring clinical trial NCT05002231?
This trial is sponsored by Fulcrum Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05002231's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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
- NCT01245179 · 18 participants · Phase 1
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
- NCT01999361 · 18 participants · NA
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
- NCT02359825 · 18 participants · Phase 1
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
- NCT02870244 · 18 participants · Phase 1
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
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