Altasciences - Kansas City
Overland Park, Kansas, 66212, United States
Location status: Recruiting
NCT Number: NCT07283770
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.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Phase 1
Overland Park, Kansas, 66212, United States
Location status: Recruiting
The study is being conducted to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581 in healthy participants and consists of Screening Phase, Treatment Phase and Safety Follow-up Phase. Additionally, VX-581 will also be administered in combination with tezacaftor (TEZ)/deutivacaftor (D-IVA) or D-IVA for up to ten days. Note: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
Suspension for Oral Administration.
Suspension for Oral Administration.
Tablet for Oral Administration.
Other names: deutivacaftor
Tablet for Oral Administration.
Other names: tezacaftor
Time frame: From Day -1 up to Day 8
Time frame: From Day -1 up to Day 17
Time frame: From Day -1 up to Day 17
Time frame: On Day 1
Time frame: On Day 1
Time frame: On Days 1, 7, and 10
Time frame: On Days 1, 7, and 10
Time frame: On Days 1, 7, and 10
Time frame: On Days 1, 7, and 10
Contact information is provided by the study sponsor or research team.
Vertex Pharmaceuticals Incorporated
Industry
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-581 in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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