A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-581 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- VX-581
- Conditions
- Not specified
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581.
Detailed Description
The study is being conducted to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581 in healthy participants and consists of Screening Phase, Treatment Phase and Safety Follow-up Phase. 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.).
Investigators
Eligibility Criteria
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
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.
Arms & Interventions
Part B: Multiple Ascending Dose
Participants will be randomized to receive multiple doses of VX-581.
Intervention: VX-581
Placebo: Part B
Participants will be randomized to receive multiple doses of placebo matched to VX-581.
Intervention: Placebo
Part A: Single Ascending Dose
Participants will be randomized to receive a single dose of VX-581.
Intervention: VX-581
Placebo: Part A
Participants will be randomized to receive a single dose of placebo matched to VX-581.
Intervention: Placebo
Outcomes
Primary Outcomes
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 34
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 66
Secondary Outcomes
- Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-581(From Day 1 up to Day 34)
- Part B: Maximum Observed Plasma Concentration (Cmax) of VX-581(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-581(From Day 1 up to Day 66)
- Part A: Maximum Observed Plasma Concentration (Cmax) of VX-581(From Day 1 up to Day 34)