NCT05541471 is a Phase 1 clinical trial of VX-548 in Pain, sponsored by Vertex Pharmaceuticals Incorporated.

Who is sponsoring NCT05541471?

NCT05541471 is sponsored by Vertex Pharmaceuticals Incorporated.

What drugs are being tested in NCT05541471?

Interventions in NCT05541471: VX-548, Midazolam, Digoxin.

Is NCT05541471 still recruiting?

NCT05541471 is currently completed. Last updated 20 March 2024.

Last reviewed 2024-03-20 · How we verify

NCT05541471

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Pharmacokinetic Drug-drug Interactions Between VX-548, Midazolam, and Digoxin

Completed Phase 1 Last updated 20 March 2024

What this trial tests

Phase 1 trial testing VX-548 in Pain in 37 participants. Completed in 28 April 2023.

Timeline

22 September 2022

Primary endpoint
16 April 2023

28 April 2023

Quick facts

Lead sponsor	Vertex Pharmaceuticals Incorporated
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	basic science
Enrollment	37
Start date	22 September 2022
Primary completion	16 April 2023
Estimated completion	28 April 2023
Sites	1 location across United States

Drugs / interventions tested

VX-548 — full drug profile →
Midazolam (midazolam) — full drug profile →
Digoxin (digoxin) — full drug profile →

Conditions studied

Pain — all drugs for Pain →

Sponsor

Vertex Pharmaceuticals Incorporated — full company profile →

Who can join

Adults 18 to 55, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the pharmacokinetics of midazolam and digoxin in the absence and presence of VX-548.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Suzetrigine, a Non-Opioid Small-Molecule Analgesic: Mechanism of Action, Clinical, and Translational Science.
Rajasingham R, Qi Y. · · 2025 · cited 3× · PMID 41251403 · DOI 10.1111/cts.70414
Suzetrigine, a Na<sub>V</sub>1.8 Inhibitor as a Novel Approach for Pain Therapy-A Medicinal and Chemical Drug Profile.
Medhat RM, Kotb OA, Baecker D. · · 2026 · cited 1× · PMID 41599406 · DOI 10.3390/molecules31020358

Verify or expand the search:

Other trials of VX-548

Trials testing the same drug.

NCT06420765 — A Microneurography Study of NaV1.8 Inhibition in Healthy Adults · Phase 1 · completed
NCT06176196 — Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR) · Phase 2 · completed
NCT05851157 — A Study to Evaluate the Effect of Food on the Pharmacokinetics of VX-548 · Phase 1 · completed
NCT05818852 — A Study to Evaluate the Effect of VX-548 on the QT/QTc Interval in Healthy Participants · Phase 1 · completed
NCT05704556 — Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Renal Impairment · Phase 1 · completed

Other recruiting trials for Pain

Currently open trials in the same condition.

NCT07533409 — Tactile and Pain Sensory Thresholds and Hand Grip Strength · recruiting
NCT07294092 — Ketamine and Propofol NeuroImaging · EARLY_PHASE1 · recruiting
NCT07290205 — Remimazolam NeuroImaging · EARLY_PHASE1 · recruiting
NCT07487610 — Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older · recruiting
NCT07454993 — The Effect of Music During Colonoscopy · NA · recruiting

Other Vertex Pharmaceuticals Incorporated trials

Trials by the same sponsor.

NCT05951205 — Evaluation of Efficacy and Safety of a Single Dose of Exa-cel in Participants With Severe Sickle Cell Disease, βS/ βC Ge · Phase 3 · withdrawn
NCT07501702 — A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis · Phase 2 · not yet recruiting
NCT07437105 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants · Phase 1 · recruiting
NCT07378865 — Evaluation of the Excretion of Suzetrigine Into Breast Milk in Healthy Lactating Female Participants · Phase 1 · recruiting
NCT07349394 — Effect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) on the PK of Rosuvastatin in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05541471 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated
Last refreshed: 20 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05541471.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing