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Relative Bioavailability and Food Effect Study of Losmapimod 15 mg Tablets

NCT05002231 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-11-12

No results posted yet for this 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

Conditions

  • Healthy Adult Subjects

Interventions

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.

Sponsors & Collaborators

  • Fulcrum Therapeutics

    lead INDUSTRY

Principal Investigators

  • Michelle Mellion, MD · Fulcrum Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-19
Primary Completion
2021-10-05
Completion
2021-10-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05002231 on ClinicalTrials.gov