A Phase 1 Dose Escalation Study of VX-708 in Healthy Participants

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Placebo; Drug: Itraconazole; Drug: VX-708; Drug: Midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT05518734

VX22-708-003

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple ascending doses of VX-708 in healthy participants

Full 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.).

Enrollment: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male and female of non-childbearing potential are eligible
• Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m^2)
• A total body weight greater than (>) 50 kg

Key Exclusion Criteria:

• History of febrile illness or other acute illness within 14 days before the first dose of study drug

• History of cardiac dysrhythmias

• Part A Cohorts with Midazolam DDI Evaluation (Cohort A4) Only

  • Hypersensitivity to midazolam or benzodiazepines

• Part A Cohorts with CSF Sampling (Cohorts A2 and A3) Only

  • Hypersensitivity to local anesthetic for lumbar puncture
  • History of conditions leading to increased intracranial pressure (e.g., brain tumor, idiopathic intracranial hypertension, venous sinus thrombosis)

• Part B Only

  • Hypersensitivity to itraconazole

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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64 participants in 4 patient groups, including a placebo group

Part A: VX-708 (Cohort A1-A3)

Experimental group

Description:

Participants will receive multiple doses of one of different dose levels of VX-708 under fasting condition.

Treatment:

Drug: VX-708

Part A: Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to VX-708.

Treatment:

Drug: Placebo

Part A: Midazolam With or Without VX-708 (Cohort A4)

Experimental group

Description:

Participants will receive a single dose of Midazolam with or without VX-708 under fasting condition.

Treatment:

Drug: VX-708

Drug: Midazolam

Part B: VX-708 With Itraconazole

Experimental group

Description:

Participants will receive a single dose of VX-708 in treatment period 1, followed by itraconazole, which will be dosed daily with a single dose of VX-708 administered in treatment period 2 under fasting conditions. A washout period of 6 days will be maintained between the 2 treatment periods.

Treatment:

Drug: VX-708

Drug: Itraconazole