Clinical trial NCT06392659: A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults
Official title: A Phase 1, Open-label Study Evaluating the Effect of VX-993 on the Pharmacokinetics of Midazolam, and the Effect of Itraconazole and Gemfibrozil on the Pharmacokinetics of VX-993, in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2024-04-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetics (PK), drug-drug interaction, and safety and tolerability of VX-993 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
* Nonsmoker or ex-smoker for at least 3 months before the first study drug dose

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, distribution, metabolism, or excretion

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Part A: Maximum Observed Plasma Concentration (Cmax) of Midazolam in Absence or Presence of VX-993
timeFrame: Pre-dose up to Day 15
measure: Part A: Maximum Observed Plasma Concentration (Cmax) of 1-Hydroxy-Midazolam in Absence or Presence of VX-993
timeFrame: Pre-dose up to Day 15
measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in Absence and Presence of VX-993
timeFrame: Pre-dose up to Day 15
measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of 1-Hydroxy-Midazolam in Absence and Presence of VX-993
timeFrame: Pre-dose up to Day 15
measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993 in Absence or Presence of Itraconazole
timeFrame: Pre-dose up to Day 27
measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993 in Absence or Presence of Itraconazole
timeFrame: Pre-dose up to Day 27
measure: Part C: Maximum Observed Plasma Concentration (Cmax) of VX-993 in Absence or Presence of Gemfibrozil
timeFrame: Pre-dose up to Day 27
measure: Part C: Area Under the Concentration Versus Time Curve (AUC) of VX-993 in Absence or Presence of Gemfibrozil
timeFrame: Pre-dose up to Day 27
Secondary 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 30
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 27
measure: Part C: 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 27
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: MAC Clinical Research
Study officials:
References: