A Phase 1 interventional study of VX-708 and Itraconazole in Pain, sponsored by Vertex Pharmaceuticals Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Vertex Pharmaceuticals Incorporated · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple ascending doses of VX-708 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.).
Vertex Pharmaceuticals Incorporated is the lead sponsor of 243 studies on the registry; 19 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 49 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Part A Cohorts with Midazolam DDI Evaluation (Cohort A4) Only
Part A Cohorts with CSF Sampling (Cohorts A2 and A3) Only
Part B Only
Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will receive multiple doses of one of different dose levels of VX-708 under fasting condition.
Drug: VX-708
Participants will receive placebo matched to VX-708.
Drug: Placebo
Participants will receive a single dose of Midazolam with or without VX-708 under fasting condition.
Drug: VX-708 · Drug: Midazolam
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.
Drug: VX-708 · Drug: Itraconazole
Solution for intravenous (IV) administration.
Solution for oral administration.
Solution for oral administration.
Placebo matched to VX-708 for IV administration.
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to Day 30
Part A: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
Time frame: Day 1 up to Day 30
Part A: Continuous Pulse Oximetry Monitoring as assessed by oxygen saturation for Cohort A4
Time frame: Pre-dose up to 6 hours Post-dose
Part A: Infusion Nurses Society (INS) Visual Infusion Phlebitis (VIP) Score Monitoring
Time frame: Day 1 up to Day 30
Part B: Area Under the Plasma Concentration Versus Time Curve from the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-708 in the Absence or Presence of Itraconazole
Time frame: Day 1 up to Day 16
Part A: Area Under the Plasma Concentration Versus Time Curve from the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-708
Time frame: Day 1 up to Day 14
Part A: Area Under the Concentration Versus Time Curve from the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Midazolam and 1-hydroxy-midazolam in the Absence or Presence of VX-708 (Cohort A4)
Time frame: Day 1 up to Day 14
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to Day 32
Part B: Infusion Nurses Society (INS) Visual Infusion Phlebitis (VIP) Score
Time frame: Day 1 up to Day 30
Plan to share: No — Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Vertex Pharmaceuticals Incorporated