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

Active Not RecruitingPhase 1, Phase 2

Sponsor: Vertex Pharmaceuticals Incorporated

Conditions: Myotonic Dystrophy Type 1 (DM1)

Interventions: VX-670, Placebo

Countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Netherlands

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 64 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

\- Documented clinical diagnosis of DM1 with age of onset greater than (\>) 1 year of age and documented positive genetic test for DM1 in the subject with cytosine thymine guanine (CTG) repeat of at least 100

Key Exclusion Criteria:

\- History of any illness or any clinical condition as pre-specified in the protocol

Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (26)

San Carlos, California, United States
Gainesville, Florida, United States
Fairway, Kansas, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Winston-Salem, North Carolina, United States
Philadelphia, Pennsylvania, United States
Richmond, Virginia, United States
Auchenflower, Australia
Melbourne, Australia
Leuven, Belgium
Chicoutimi, Canada
Montreal, Canada
Montreal, Canada
Ottawa, Canada
Québec, Canada
Paris, France
München, Germany
Milan, Italy
Maastricht, Netherlands
Valencia, Spain
Glasgow, United Kingdom
London, United Kingdom
London, United Kingdom
Salford, United Kingdom
Sheffield, United Kingdom