Health TrialsbyHealthPanel

Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 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 and multiple ascending doses of VX-272 in combination with deutivacaftor (D-IVA) with or without tezacaftor (TEZ) in healthy subjects.

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

Male and Female participants of non-childbearing potential

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-272

    Drug

    Suspension for Oral Administration.

  • Placebo

    Drug

    Suspension for Oral Administration.

  • Tezacaftor

    Drug

    Tablet for oral administration.

  • Deutivacaftor

    Drug

    Tablet for oral administration.

Treatment groups

160 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-272 in Combination With Tezacaftor (TEZ)/ Deutivacaftor (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 Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 34)
2

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

Time frame
From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 66)
3

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

Time frame
From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 66)

Secondary outcomes

1

Part A: Maximum Observed Plasma Concentration (Cmax) of VX-272

Time frame
From Day 1 up to Day 34
2

Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-272

Time frame
From Day 1 up to Day 34
3

Part B: Maximum Observed Plasma Concentration (Cmax) of VX-272

Time frame
From Day 1 up to Day 66
4

Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-272

Time frame
From Day 1 up to Day 66

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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