Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • VX-433

    Drug

    Suspension for Oral Administration

  • Placebo

    Drug

    Suspension for Oral Administration

  • Midazolam

    Drug

    Syrup for Oral Administration

  • Bupropion

    Drug

    Capsule for Oral Administration

Treatment groups

118 Participants
are divided into 5 treatment groups
Group A: Part A: Single Ascending Dose (SAD)Experimental treatment 1 intervention
Group B: Part A: PlaceboPlacebo comparator 1 intervention
Group C: Part B: Multiple Ascending Dose (MAD)Experimental treatment 1 intervention
Group D: Part B: PlaceboPlacebo comparator 1 intervention
Group E: Part C: Drug Drug InteractionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
From Day 1 up to Day 6
2

Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
From Day 1 up to Day 18
3

Part C: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-433

Time frame
From Day 1 up to Day 22
4

Part C: Maximum Observed Plasma Concentration (Cmax) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433

Time frame
From Day 1 up to Day 22

Secondary outcomes

1

Part A: Maximum Observed Plasma Concentration (Cmax) of VX-433

Time frame
From Day 1 up to Day 6
2

Part B: Maximum Observed Plasma Concentration (Cmax) of VX-433

Time frame
From Day 1 up to Day 18
3

Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-433

Time frame
From Day 1 up to Day 6
4

Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-433

Time frame
From Day 1 up to Day 18

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vertex Pharmaceuticals Incorporated

Lead sponsor

Source ClinicalTrials.gov
Apply now