NCT05002231

Relative Bioavailability and Food Effect Study of Losmapimod 15 mg Tablets

A Phase 1, Open-Label, 3-Period, Randomized, Single-Dose, Crossover Study to Assess the Relative Bioavailability and the Effect of Food on the Pharmacokinetics of a New 15 mg Tablet of Losmapimod Versus the Current 7.5 mg Tablet

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Fulcrum Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

This study is a Phase 1, open-label, 3-period, 6-sequence, randomized, single-dose, crossover study designed to assess the relative bioavailability of a 15 mg tablet of losmapimod versus two 7.5 mg tablets of losmapimod under fasted conditions and to assess the effect of food on the pharmacokinetics of a 15 mg tablet of losmapimod under fasted and fed conditions in 18 healthy subjects. The study will consist of a screening period, 3 treatment periods with a single dose of study drug per treatment period, a 48-hour washout period between dosing, and an end of study visit. Subjects will be randomly assigned to receive 1 of 6 treatment sequences (3 subjects per treatment sequence) prior to dosing on Day 1 of Period 1. The primary endpoint of the study is to assess the relative bioavailability and the effect of food on the pharmacokinetics of a new 15 mg tablet formulation of losmapimod. Secondary endpoints include assessing the safety and tolerability and evaluating target engagement in the blood of a new 15 mg tablet formulation of losmapimod in healthy subjects.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	Losmapimod 15 mg oral tablet	Subjects will receive one losmapimod 15 mg tablet by mouth under fasted conditions.
DRUG	Losmapimod two 7.5 mg oral tablets	Subjects will receive two losmapimod 7.5 mg tablets by mouth under fasted conditions.
DRUG	Losmapimod one 15 mg oral tablet	Subjects will receive one losmapimod 15 mg tablet by mouth under fed conditions.

Timeline

• Start date: 2021-08-19
• Primary completion: 2021-10-05
• Completion: 2021-10-22
• First posted: 2021-08-12
• Last updated: 2021-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study