Health TrialsbyHealthPanel

Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants

ConditionCystic Fibrosis
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 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m²)

A total body weight of more than (>) 50 kg

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • VX-581

    Drug

    Suspension for Oral Administration.

  • Placebo

    Drug

    Suspension for Oral Administration.

  • D-IVA

    Drug

    Tablet for Oral Administration.

  • TEZ

    Drug

    Tablet for Oral Administration.

Treatment groups

136 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part A: Single Ascending DoseExperimental treatment 1 intervention
Group B: Placebo: Part APlacebo comparator 1 intervention
Group C: Part B: Multiple Ascending DoseExperimental treatment 1 intervention
Group D: Placebo: Part BPlacebo comparator 1 intervention
Group E: Part C: VX-581 with TEZ/D-IVA or D-IVAExperimental treatment 3 interventions
Group F: Placebo: Part CPlacebo comparator 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 8
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 17
3

Part C: 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 17

Secondary outcomes

1

Part A: Maximum Observed Plasma Concentration (Cmax) of VX-581

Time frame
On Day 1
2

Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) Post-Dose of VX-581

Time frame
On Day 1
3

Part B: Maximum Observed Plasma Concentration (Cmax) of VX-581

Time frame
On Days 1, 7, and 10
4

Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) Post-Dose of VX-581

Time frame
On Days 1, 7, and 10

Other outcomes

Sponsors and contacts

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

Vertex Pharmaceuticals Incorporated

Lead sponsor

Source ClinicalTrials.gov
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