Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants
Recruiting
Phase 1
Interventional Study
Cystic Fibrosis
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 55
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 136 (estimated)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
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About This Trial
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 for up to ten days.
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* 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
* Male and Female participants of non-childbearing potential
Key Exclusion Criteria:
* History of febrile illness or other acute illness that has not f…
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