VX-634
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StatusAccepting Candidates
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Age18 Years - 55 Years
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SexesAll
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Healthy VolunteersAccepts Healthy Volunteers
Objective
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-634 at various doses.
Description
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.).
Details
Full study title | A Phase 1, First-In-Human Study of Safety, Tolerability, and Pharmacokinetics of VX-634 |
Protocol number | OCR43388 |
ClinicalTrials.gov ID | NCT05579431 |
Phase | Phase 1 |
Eligibility
Key Inclusion Criteria:
Participants of age between 18 to 55 years (inclusive)
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
Participants of non childbearing potential
Non smoker or ex-smoker for at least 3 months before screening
Key Exclusion Criteria:
- Any condition possibly affecting drug absorption
Other protocol defined Inclusion/Exclusion criteria may apply.
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
Mark Brantly -
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.