A Phase 1 interventional study of VX-973 and Placebo in 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 2024-05-06.
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 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.).
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. The dose and frequency will be determined based on Part A. Midazolam is planned to be administered as single oral doses of 2 mg first alone on Day -1 and then co-administered with study drug on Day 27.
Drug: VX-973 · Drug: Midazolam
Participants will be randomized to receive placebo matched to VX-973.
Drug: Placebo
Participants will be randomized to receive placebo matched to VX-973. Midazolam is planned to be administered as single oral doses of 2 mg first alone on Day -1 and then co-administered with placebo matched to VX-973 on Day 27.
Drug: Placebo · Drug: Midazolam
Suspension for oral administration.
Suspension for oral administration.
Syrup 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 31
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 43
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 43
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 43
Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-973
Time frame: Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose
Part B: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in the Absence and Presence of VX-973
Time frame: Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose
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 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vertex Pharmaceuticals Incorporated