A Phase 1, Open-label ,VX-993 on the PK of Midazolam, Itraconazole and Gemfibrozil on Healthy Adults

• Research type

  Research Study

• Full title

  A Phase 1, Open-label Study Evaluating the Effect of VX-993 on the Pharmacokinetics of Midazolam, and the Effect of Itraconazole and Gemfibrozil on the Pharmacokinetics of VX-993, in Healthy Adults

• IRAS ID

  1009703

• Contact name

  Toluwalope Cole

• Contact email

  Tolu_Cole@vrtx.com

• Sponsor organisation

  Vertex Pharmaceuticals Incorporated

• Clinicaltrials.gov Identifier

  NCT06392659

• Research summary

  This phase 1 study is being done to find out how VX-993, a new investigational drug developed for the treatment of pain, interacts with other approved medications (either Midazolam, Itraconazole or Gemfibrozil) when administered at the same time.

  Pain is one of the most common symptoms for which people seek medical attention and many of the current available treatments either have a lot of side-effects or are likely to be abused. VX-993 acts on a certain mechanism within the nerves that are involved in transmission of the signal of sensation of physical pain,

  This is an open-label, drug-drug interaction study, meaning that both the participant and the clinical team will know that the participant is taking the study drug. The study will be carried out in 3 parts and only one of each of the approved medications will be administered alongside VX-993 in each part of the study as follows:
  Part A – Midazolam
  Part B – Itraconazole
  Part C – Gemfibrozil

  The study includes a screening period that will last up to 4 weeks, a study treatment period that will last up to 23 days and a safety follow-up period that will last up to 15 days. The total study duration will be approximately 8 or 9 weeks depending on whether the participant is in Part A or Part B/C.

  Assessments include physical examinations, vital signs, pulse oximetry, electrocardiograms (ECGs), completion of questionnaires, blood and urine sample collection for testing and an optional blood sample for genetic analysis.
  Approximately 42 healthy adults, male and female aged 18 to 55 years old, will participate in this study in 1 site in the UK. The sponsor of this trial is Vertex Pharmaceuticals Inc.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  24/NW/0060

• Date of REC Opinion

  22 Apr 2024

• REC opinion

  Further Information Favourable Opinion