A Phase 1 interventional study of VX-973 and Placebo 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 2025-08-26.
Sponsored by Vertex Pharmaceuticals Incorporated · Phase 1, Interventional, and Treatment
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of VX-973 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.).
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 1,904 interventional studies indexed under Pain.
Browse Pain studies →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:
Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will be randomized to receive a single dose of VX-973 under fasted conditions.
Drug: VX-973
Participants will be randomized to receive multiple doses of VX-973 under fasted conditions.
Drug: VX-973
Participants will be randomized to receive placebo matched to VX-973.
Drug: Placebo
Participants will be randomized to receive placebo matched to VX-973.
Drug: Placebo
Suspension for oral administration.
Suspension for oral administration.
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day -1 up to Day 30
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day -1 up to Day 85
Part A: Maximum Observed Plasma Concentration (Cmax) of VX-973
Time frame: From Day 1 up to Day 30
Part B: Maximum Observed Plasma Concentration (Cmax) of VX-973
Time frame: From Day 1 up to Day 85
Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-973
Time frame: From Day 1 up to Day 30
Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-973
Time frame: From Day 1 up to Day 85
Part A: Time Taken for VX-973 to Reach Maximum Concentration (tmax)
Time frame: From Day 1 up to Day 30
Part B: Time Taken for VX-973 to Reach Maximum Concentration (tmax)
Time frame: From Day 1 up to Day 85
Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test
Time frame: From Day 1 up to Day 53
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 Aug 2025. You cannot join it, but the record below documents what was studied.
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Vertex Pharmaceuticals Incorporated