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A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults - Trial NCT06392659

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.

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NCT06392659
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06392659
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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

Study Focus

Pain

VX-993

Interventional

drug

Sponsor & Location

Vertex Pharmaceuticals Incorporated

Timeline & Enrollment

Phase 1

Apr 01, 2024

Jul 01, 2024

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, unspecified
Pain, not elsewhere classified
Pain in limb
Acute pain
Other chronic pain

Data Source

ClinicalTrials.gov

NCT06392659

Non-Device Trial