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

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Itraconazole; Midazolam

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.