A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants
- Registration Number
- NCT05324410
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and PK of single and multiple ascending doses of VX-840 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
- 88
Inclusion Criteria
- Female participants must be of non-childbearing potential
- 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
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: VX-840 VX-840 Participants will be randomized to receive single dose of one of different dose levels of VX-840. Part A: Placebo Placebo Participants will receive placebo matched to VX-840. Part B: VX-840 VX-840 Participants will be randomized to receive multiple doses of one of different dose levels of VX-840. The dose levels will be determined based on the data from Part A. Part B: Placebo Placebo Participants will receive placebo matched to VX-840.
- Primary Outcome Measures
Name Time Method Parts A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Day 1 up to Day 25
- Secondary Outcome Measures
Name Time Method Parts A and B: Plasma Concentration of VX-840 Over Time From Day 1 up to Day 14 Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity [AUC(0 - inf)] From Day 1 up to Day 14 Part B: Amount of VX-840 Excreted in the Urine During the Dosing Interval (Ae) From Day 1 up to Day 14 Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration [AUC(0-tlast)] From Day 1 up to Day 14 Part B: Associated Renal Clearance (CLr) of VX-840 From Day 1 up to Day 14
Trial Locations
- Locations (1)
ICON Lenexa
🇺🇸Lenexa, Kansas, United States