A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral VX-708 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Acute Pain
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of VX-708 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
- •Male and female of non-childbearing potential are eligible
- •Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m\^2)
- •A total body weight greater than (\>) 50 kg
Exclusion Criteria
- •History of febrile illness or other acute illness within 14 days before the first dose of study drug
- •Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
- •History of cardiac dysrhythmias
- •Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
Part A: Placebo
Participants will receive placebo matched to VX-708.
Intervention: Placebo
Part B: VX-708
Participants will be randomized to receive multiple doses of different dose levels of VX-708. The dose levels will be determined based on the data from Part A.
Intervention: VX-708
Part A: VX-708
Participants will be randomized to receive a single dose of different dose levels of VX-708.
Intervention: VX-708
Part B: Placebo
Participants will receive placebo matched to VX-708.
Intervention: Placebo
Outcomes
Primary Outcomes
Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
Time Frame: From Day 1 up to Day 25
Parts A and 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 25
Secondary Outcomes
- Parts A and B: Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-708(From Day 1 up to Day 25)
- Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test(From Day 1 up to Day 11)