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

NCT06392659 | Completed Phase 1 FDA Drug

• 1 other identifier: VX24-993-004
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• 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

Study Arms (3)

Part A: Midazolam

EXPERIMENTAL

Participants will receive a single dose of Midazolam in absence and presence of VX-993.

Drug: VX-993; Drug: Midazolam

Part B: Itraconazole

EXPERIMENTAL

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; Drug: Itraconazole

Part C: Gemfibrozil

EXPERIMENTAL

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; Drug: Gemfibrozil

Interventions

VX-993 DRUG

Suspension for Oral Administration.

Part A: Midazolam; Part B: Itraconazole; Part C: Gemfibrozil

Gemfibrozil DRUG

Tablets for Oral Administration.

Part C: Gemfibrozil

Itraconazole DRUG

Capsules for Oral Administration.

Part B: Itraconazole

Midazolam DRUG

Solution for Oral Administration.

Part A: Midazolam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

MAC Clinical Research

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Pain

Interventions

Gemfibrozil; Itraconazole; Midazolam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Pentanoic Acids; Valerates; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Volatile; Fatty Acids; Lipids; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: May 2, 2024
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)