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

NCT ID: NCT05518734

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-17
• Study Completion Date: 2023-03-07

Brief Summary

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

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

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

Group Type: EXPERIMENTAL

VX-708

Intervention Type: DRUG

Solution for intravenous (IV) administration.

Part A: Placebo

Participants will receive placebo matched to VX-708.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matched to VX-708 for IV administration.

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

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

Group Type: EXPERIMENTAL

VX-708

Intervention Type: DRUG

Solution for intravenous (IV) administration.

Midazolam

Intervention Type: DRUG

Solution for oral administration.

Part B: VX-708 With Itraconazole

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.

Group Type: EXPERIMENTAL

VX-708

Intervention Type: DRUG

Solution for intravenous (IV) administration.

Itraconazole

Intervention Type: DRUG

Solution for oral administration.

Interventions

VX-708

Solution for intravenous (IV) administration.

Intervention Type: DRUG

Itraconazole

Solution for oral administration.

Intervention Type: DRUG

Midazolam

Solution for oral administration.

Intervention Type: DRUG

Placebo

Placebo matched to VX-708 for IV administration.

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Celerion - Tempe

Tempe, Arizona, United States

Countries

United States

Other Identifiers

VX22-708-003

Identifier Type: -

Identifier Source: org_study_id