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NCT06392659Not yet recruiting

A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults

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
Vertex Pharmaceuticals IncorporatedPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Pain
Drug/Device/Intervention
VX-993
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Vertex Pharmaceuticals Incorporated
Timeline & enrollment
Phase
Phase 1
Start date
Apr 01, 2024
End date
Jul 01, 2024
Enrollment
42 participants
Primary outcome

Part A: Maximum Observed Plasma Concentration (Cmax) of Midazolam in Absence or Presence of VX-993,Part A: Maximum Observed Plasma Concentration (Cmax) of 1-Hydroxy-Midazolam in Absence or Presence of VX-993,Part A: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in Absence and Presence of VX-993,Part A: Area Under the Concentration Versus Time Curve (AUC) of 1-Hydroxy-Midazolam in Absence and Presence of VX-993,Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993 in Absence or Presence of Itraconazole,Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993 in Absence or Presence of Itraconazole,Part C: Maximum Observed Plasma Concentration (Cmax) of VX-993 in Absence or Presence of Gemfibrozil,Part C: Area Under the Concentration Versus Time Curve (AUC) of VX-993 in Absence or Presence of Gemfibrozil

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK), drug-drug interaction,
 and safety and tolerability of VX-993 in healthy participants.

ICD-10 classifications
Pain, unspecifiedPain, not elsewhere classifiedPain in limbAcute painOther chronic pain
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06392659
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06392659 through Pure Global AI's free database. This Phase 1 trial is sponsored by Vertex Pharmaceuticals Incorporated and is currently Not yet recruiting. The study focuses on Pain. Target enrollment is 42 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.