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NCT07283770
Evaluation of VX-581 in Healthy Participants and in Participants With Cystic Fibrosis
Conditions: Cystic Fibrosis
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 152
Sponsor: Vertex Pharmaceuticals Incorporated
Location: Altasciences - Kansas City Overland Park Kansas
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single dose of VX-581 and multiple ascending doses of VX-581 alone and in combination with tezacaftor (TEZ)/deutivacaftor (D-IVA) or D-IVA in healthy participants. The study will also evaluate the safety, tolerability, and pharmacokinetics of VX-581 administered in combination with D-IVA with or without TEZ in participants with cystic fibrosis (CF).
Eligibility Criteria
Key Inclusion Criteria:
* Parts A, B, C:
* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of more than (\>) 50 kg
* Part D:
* Confirmed diagnosis of CF
Key Exclusion Criteria:
* Parts A, B, C:
* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* Part D:
* History of clinically significant cirrhosis with or without portal hypertension.
Other protocol defined Inclusion/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT07283770). StuddyBuddy aggregates publicly available trial information.
