Clinical trial NCT05866055: A Phase 1 Dose Escalation Study of VX-973 in Healthy Adults
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of VX-973 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2023-05-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of VX-973 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.).

Eligibility criteria: Key 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 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.

Primary outcomes:
measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 31
measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 43
Secondary outcomes:
measure: Part A: Maximum Observed Plasma Concentration (Cmax) of VX-973
timeFrame: From Day 1 up to Day 30
measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VX-973
timeFrame: From Day 1 up to Day 43
measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-973
timeFrame: From Day 1 up to Day 30
measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-973
timeFrame: From Day 1 up to Day 43
measure: Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-973
timeFrame: Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose
measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in the Absence and Presence of VX-973
timeFrame: Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: PAREXEL International
Study officials:
References: