A Phase 1 interventional study of VX-708 and Placebo in Acute Pain, sponsored by Vertex Pharmaceuticals Incorporated. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-15.
Sponsored by Vertex Pharmaceuticals Incorporated · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of VX-708 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.).
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 100 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute 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 different dose levels of VX-708.
Drug: VX-708
Participants will receive placebo matched to VX-708.
Drug: Placebo
Participants will be randomized to receive multiple doses of different dose levels of VX-708. The dose levels will be determined based on the data from Part A.
Drug: VX-708
Participants will receive placebo matched to VX-708.
Drug: Placebo
Solution or suspension for oral administration.
Placebo matched to VX-708 for oral administration.
Parts A and 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 25
Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
Time frame: From Day 1 up to Day 25
Parts A and B: Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-708
Time frame: From Day 1 up to Day 25
Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test
Time frame: From Day 1 up to Day 11
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 May 2023. You cannot join it, but the record below documents what was studied.
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Vertex Pharmaceuticals Incorporated