A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Escalation Study Evaluating the Safety and Pharmacokinetics of Intravenous VX-993 in Healthy Adults
Overview
- Phase
- Phase 1
- Intervention
- VX-993
- Conditions
- Pain
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of intravenously administered VX-993 at different doses in healthy participants.
Detailed Description
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), inclusive
- •A total body weight of more than (\>) 50 kg
- •Nonsmoker or ex-smoker for at least 3 months before first dose of the study drug
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 distribution, metabolism, or excretion
- •Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
Part A: Single Ascending Dose (SAD)
Participants will be randomized to receive a single dose of different dose levels of VX-993.
Intervention: VX-993
Placebo Part A
Participants will be randomized to receive placebo matched to VX-993.
Intervention: Placebo
Part B: Multiple Ascending Dose (MAD)
Participants will be randomized to receive multiple doses of different dose levels of VX-993. The dose levels will be determined based on the data from Part A.
Intervention: VX-993
Placebo Part B
Participants will be randomized to receive multiple doses of placebo matched to VX-993.
Intervention: Placebo
Outcomes
Primary Outcomes
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 up to Day 43
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 up to Day 16
Secondary Outcomes
- Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993(Pre-dose up to Day 16)
- Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993(Pre-dose up to Day 43)
- Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993(Pre-dose up to Day 16)
- Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993(Pre-dose up to Day 43)