A Phase 1 Dose Escalation Study of VX-993 in Healthy Participants
- Registration Number
- NCT05653323
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of 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.).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
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
- Participants of non-childbearing potential
- Nonsmoker or ex-smoker for at least 3 months before screening
Key
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
Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Single Ascending Dose (SAD) VX-993 Participants will be randomized to receive a single dose of different dose levels of VX-993. Placebo Part A Placebo Participants will be randomized to receive placebo matched to VX-993. Placebo Part B Placebo Participants will be randomized to receive multiple doses of placebo matched to VX-993. Part B: Multiple Ascending Dose (MAD) VX-993 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.
- Primary Outcome Measures
Name Time Method Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Day 1 up to Day 25 Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Day 1 up to Day 25 Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Pre-dose up to Day 25
- Secondary Outcome Measures
Name Time Method Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993 Pre-dose up to Day 25 Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993 Pre-dose up to Day 25 Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993 Pre-dose up to Day 25 Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993 Pre-dose up to Day 25 Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test Day 1, Day 10, and Day 11
Trial Locations
- Locations (1)
MAC Clinical Research
🇬🇧Manchester, United Kingdom