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A Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1)

Study acronym: Galileo
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Enrollment target: estimated 52 to confirmed 47 · Site details revised at 26 of 26 sitesv18 Show 2 more changesShow less
    • Enrollment target: estimated 52 to confirmed 47
    • Site details revised at 26 of 26 sites
  2. Primary and study completion pushed from Dec 22, 2026 to Feb 2, 2027 Enrollment increased: 44 → 52 participantsv17 Show 1 more changeShow less
    • Enrollment increased: 44 → 52 participants
  3. Enrollment target: 36 to 44 Primary and study completion dates: Dec 31, 2026 to Dec 22, 2026 · Secondary endpoints: details revised at 2 of 6 entriesv16 Show 2 more changesShow less
    • Primary and study completion dates: Dec 31, 2026 to Dec 22, 2026
    • Secondary endpoints: details revised at 2 of 6 entries
  4. Re-verified, no change to tracked fieldsv15
  5. Study sites: 11 to 26 Primary and study completion dates: Dec 2026 to Dec 31, 2026v14 Show 1 more changeShow less
    • Primary and study completion dates: Dec 2026 to Dec 31, 2026
Show 12 earlier versionsHide 12 earlier versions
  1. Re-verified, no change to tracked fieldsv13
  2. Study sites: 10 to 11v12
  3. Study sites: 9 to 10v11
  4. Study sites: 8 to 9v10
  5. Study sites: 7 to 8v9
  6. Study sites: 6 to 7v8
  7. Study sites: 5 to 6v7
  8. Study sites: 3 to 5v6
  9. Study sites: 1 to 3v5
  10. Start date changed from estimate of Feb 2024 to Feb 20, 2024v4
  11. Start date: Jan 2024 to Feb 2024v3
  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VX-670 at different single and multiple doses in participants with DM1.
Trial Details
NCT Number NCT06185764
Lead Sponsor Vertex Pharmaceuticals Incorporated
Conditions Myotonic Dystrophy Type 1 (DM1)
Enrollment 47 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov