A Phase 1, First-in-human Study of VX-433
ConditionNarcolepsy Type 1 (NT1)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorVertex Pharmaceuticals Incorporated
About this trial
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.
Eligibility criteria
Qualifiers
Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m2), inclusive
A total body weight of more than (>) 50 kg
Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening
Disqualifiers
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
For female participants: of childbearing potential, pregnant, breastfeeding, or planning to become pregnant or donate ova during the study or within 90 days after last dose of study drug
Trial design
Treatments tested in this trial
- VX-433
- Placebo
- Midazolam
- Bupropion
Treatment groups
118 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov