Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-272 in Healthy Subjects
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of VX-272 in healthy participants. Additionally, VX-272 will be administered in combination with D-IVA with or without TEZ. Note: 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.)
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Medical Information
- Phone Number: 617-341-6777
- Email: medicalinfo@vrtx.com
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85283
- Recruiting
- Celerion - Tempe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- 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
- Male and Female participants of non-childbearing potential
Key Exclusion Criteria:
- 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
Other protocol defined Inclusion/Exclusion criteria may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Part A: Single Ascending Dose
Participants will be randomized to receive a single dose of VX-272. |
Suspension for Oral Administration. |
|
Placebo Comparator: Placebo: Part A
Participants will be randomized to receive a single dose of placebo matched to VX-272. |
Suspension for Oral Administration. |
|
Experimental: Part B: Multiple Ascending Dose
Participants will be randomized to receive multiple doses of VX-272. |
Suspension for Oral Administration. |
|
Placebo Comparator: Placebo: Part B
Participants will be randomized to receive multiple doses of placebo matched to VX-272. |
Suspension for Oral Administration. |
|
Experimental: Part C: VX-272 in Combination With Tezacaftor (TEZ)/ Deutivacaftor (D-IVA) or D-IVA
Participants will be randomized to receive VX-272 in combination with TEZ/D-IVA or D-IVA. |
Suspension for Oral Administration. Tablet for oral administration.
Other Names:
Tablet for oral administration.
Other Names:
|
|
Placebo Comparator: Placebo: Part C
Participants will be randomized to receive placebo matched to VX-272 in combination with TEZ/D-IVA or D-IVA. |
Suspension for Oral Administration. Tablet for oral administration.
Other Names:
Tablet for oral administration.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 34)
|
|
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)
|
From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 66)
|
|
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)
|
From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 66)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Part A: Maximum Observed Plasma Concentration (Cmax) of VX-272
Time Frame: From Day 1 up to Day 34
|
From Day 1 up to Day 34
|
|
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
|
From Day 1 up to Day 34
|
|
Part B: Maximum Observed Plasma Concentration (Cmax) of VX-272
Time Frame: From Day 1 up to Day 66
|
From Day 1 up to Day 66
|
|
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
|
From Day 1 up to Day 66
|
|
Part C: Maximum Observed Plasma Concentration (Cmax) of VX-272 and its Metabolites
Time Frame: From Day 1 up to Day 66
|
From Day 1 up to Day 66
|
|
Part C: Maximum Observed Plasma Concentration (Cmax) of TEZ and D-IVA and their Metabolites
Time Frame: From Day 1 up to Day 28
|
From Day 1 up to Day 28
|
|
Part C: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-272 and its Metabolites
Time Frame: From Day 1 up to Day 66
|
From Day 1 up to Day 66
|
|
Part C: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of TEZ and D-IVA and their Metabolites
Time Frame: From Day 1 up to Day 28
|
From Day 1 up to Day 28
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VX25-272-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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