ICON - Utah - Salt Lake City Office
Salt Lake City, Utah, 84124, United States
Location status: Recruiting
NCT Number: NCT07584434
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-433 following single and multiple ascending doses, as well as to assess the effect of VX-433 on the PK of midazolam, bupropion, and hydroxybupropion.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Phase 1
Salt Lake City, Utah, 84124, United States
Location status: Recruiting
The study is being conducted in healthy participants to evaluate the safety, tolerability, and PK of VX-433 (Parts A and B), as well as potential drug-drug interaction (DDI) between VX-433 and midazolam or bupropion (Part C).
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 will apply.
Suspension for Oral Administration
Suspension for Oral Administration
Syrup for Oral Administration
Capsule for Oral Administration
Time frame: From Day 1 up to Day 6
Time frame: From Day 1 up to Day 18
Time frame: From Day 1 up to Day 22
Time frame: From Day 1 up to Day 22
Time frame: From Day 1 up to Day 22
Time frame: From Day 1 up to Day 22
Time frame: From Day 1 up to Day 6
Time frame: From Day 1 up to Day 18
Time frame: From Day 1 up to Day 6
Time frame: From Day 1 up to Day 18
Time frame: From Day 1 up to Day 6
Time frame: From Day 1 up to Day 18
Time frame: From Day 1 up to Day 2
Time frame: From Day 1 up to Day 11
Time frame: From Day 1 up to Day 2
Time frame: From Day 1 up to Day 11
Time frame: From Day 1 up to Day 29
Contact information is provided by the study sponsor or research team.
Vertex Pharmaceuticals Incorporated
Industry
A Phase 1, First-in-human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VX-433 and Its Effects on the Pharmacokinetics of Midazolam and Bupropion
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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