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

Vertex Pharmaceuticals Incorporated42 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

VX-993DRUG

Suspension for Oral Administration.

GemfibrozilDRUG

Tablets for Oral Administration.

ItraconazoleDRUG

Capsules for Oral Administration.

Midazolam

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

MAC Clinical Research

Manchester, United Kingdom

Outcomes

Primary Outcomes

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 Midazolam in Absence and 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: Maximum Observed Plasma Concentration (Cmax) of VX-993 in Absence or Presence of Gemfibrozil

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

Secondary Outcomes

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: From Day 1 up to Day 30

Data from ClinicalTrials.gov

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