A Phase 1 Dose Escalation Study of VX-973 in Healthy Adults
Research type
Research Study
Full title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of VX‑973 in Healthy Adults
IRAS ID
1007187
Contact name
Toluwalope Cole
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Eudract number
2022-003301-30
Research summary
The purpose of this study is to test a new (investigational) drug called VX-973 in humans for the first time. VX-973 is being developed to treat pain, however, the drug will be tested in healthy participants without pain.
The main aims of this study are:
• To assess the safety and tolerability of VX-973
• To see how the body absorbs and removes VX-973 (called pharmacokinetics [PK])
• To assess the effect of VX-973 on the body
• For one cohort, how these processes may be modified in the presence of midazolam
Approximately 80 healthy participants (male and female of non-childbearing potential), will be enrolled (approximately 40 participants in Part A and approximately 40 participants in Part B) between the age of 18 through 55 years of age, inclusive.REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0096
Date of REC Opinion
19 Apr 2023
REC opinion
Further Information Favourable Opinion