A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults

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

The purpose of this study is to evaluate the pharmacokinetics (PK), drug-drug interaction, and safety and tolerability of VX-993 in healthy participants.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: VX-993; Drug: Midazolam; Drug: Itraconazole; Drug: Gemfibrozil

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.).

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • MAC Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Midazolam; Participants will receive a single dose of Midazolam in absence and presence of VX-993.	Drug: VX-993; Suspension for Oral Administration.; Drug: Midazolam; Solution for Oral Administration.
Experimental: 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.	Drug: VX-993; Suspension for Oral Administration.; Drug: Itraconazole; Capsules for Oral Administration.
Experimental: 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.	Drug: VX-993; Suspension for Oral Administration.; Drug: Gemfibrozil; Tablets for Oral Administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part A: Maximum Observed Plasma Concentration (Cmax) of Midazolam in Absence or Presence of VX-993	Pre-dose up to Day 15
Part A: Maximum Observed Plasma Concentration (Cmax) of 1-Hydroxy-Midazolam in Absence or Presence of VX-993	Pre-dose up to Day 15
Part A: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in Absence and Presence of VX-993	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	Pre-dose up to Day 15
Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993 in Absence or Presence of Itraconazole	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	Pre-dose up to Day 27
Part C: Maximum Observed Plasma Concentration (Cmax) of VX-993 in Absence or Presence of Gemfibrozil	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	Pre-dose up to Day 27

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Actual): July 2, 2024
• Study Completion (Actual): July 2, 2024

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Central Nervous System Depressants; Enzyme Inhibitors; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antimetabolites; Hormones, Hormone Substitutes, and Hormone Antagonists; Hypolipidemic Agents; Lipid Regulating Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C8 Inhibitors; Midazolam; Itraconazole; Gemfibrozil
• Other Study ID Numbers: VX24-993-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No