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
Overview
- Phase
- Phase 1
- Intervention
- VX-993
- Conditions
- Pain
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Part A: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in Absence and Presence of VX-993
- Status
- Completed
- Last Updated
- last year
Overview
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.).
Investigators
Eligibility Criteria
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
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.
Arms & Interventions
Part A: Midazolam
Participants will receive a single dose of Midazolam in absence and presence of VX-993.
Intervention: VX-993
Part A: Midazolam
Participants will receive a single dose of Midazolam in absence and presence of VX-993.
Intervention: Midazolam
Part B: Itraconazole
Participants will receive a single dose of VX-993 on Day 1 and Itraconazole once daily (qd) on Days 7 through Day 15. On Day 10 participants will receive Itraconazole followed by VX-993.
Intervention: VX-993
Part B: Itraconazole
Participants will receive a single dose of VX-993 on Day 1 and Itraconazole once daily (qd) on Days 7 through Day 15. On Day 10 participants will receive Itraconazole followed by VX-993.
Intervention: Itraconazole
Part C: Gemfibrozil
Participants will receive a single dose of VX-993 on Day 1 and Gemfibrozil every 12 hours (q12d) on Days 7 through Day 15. On Day 10 participants will receive Gemfibrozil followed by VX-993.
Intervention: VX-993
Part C: Gemfibrozil
Participants will receive a single dose of VX-993 on Day 1 and Gemfibrozil every 12 hours (q12d) on Days 7 through Day 15. On Day 10 participants will receive Gemfibrozil followed by VX-993.
Intervention: Gemfibrozil
Outcomes
Primary Outcomes
Part A: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in Absence and Presence of VX-993
Time Frame: Pre-dose up to Day 15
Part A: Maximum Observed Plasma Concentration (Cmax) of Midazolam in Absence or Presence of VX-993
Time Frame: Pre-dose up to Day 15
Part A: Maximum Observed Plasma Concentration (Cmax) of 1-Hydroxy-Midazolam in Absence or Presence of VX-993
Time Frame: Pre-dose up to Day 15
Part A: Area Under the Concentration Versus Time Curve (AUC) of 1-Hydroxy-Midazolam in Absence and Presence of VX-993
Time Frame: Pre-dose up to Day 15
Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993 in Absence or Presence of Itraconazole
Time Frame: Pre-dose up to Day 27
Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993 in Absence or Presence of Itraconazole
Time Frame: Pre-dose up to Day 27
Part C: Area Under the Concentration Versus Time Curve (AUC) of VX-993 in Absence or Presence of Gemfibrozil
Time Frame: Pre-dose up to Day 27
Part C: Maximum Observed Plasma Concentration (Cmax) of VX-993 in Absence or Presence of Gemfibrozil
Time Frame: Pre-dose up to Day 27
Secondary Outcomes
- Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 30)
- Part 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 27)
- Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 27)