NCT05535959 is a Phase 1 clinical trial of VX-121/TEZ/D-IVA in Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.

Who is sponsoring NCT05535959?

NCT05535959 is sponsored by Vertex Pharmaceuticals Incorporated.

What drugs are being tested in NCT05535959?

Interventions in NCT05535959: VX-121/TEZ/D-IVA.

What condition does NCT05535959 study?

NCT05535959 studies Cystic Fibrosis.

Is NCT05535959 still recruiting?

NCT05535959 is currently completed. Last updated 12 December 2022.

Last reviewed 2022-12-12 · How we verify

NCT05535959

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 Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121/Tezacaftor/Deutivacaftor

Completed Phase 1 Last updated 12 December 2022

What this trial tests

Phase 1 trial testing VX-121/TEZ/D-IVA in Cystic Fibrosis in 16 participants. Completed in 9 November 2022.

Timeline

15 September 2022

Primary endpoint
9 November 2022

9 November 2022

Quick facts

Lead sponsor	Vertex Pharmaceuticals Incorporated
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	15 September 2022
Primary completion	9 November 2022
Estimated completion	9 November 2022
Sites	1 location across United States

Drugs / interventions tested

VX-121/TEZ/D-IVA — full drug profile →

Conditions studied

Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

Vertex Pharmaceuticals Incorporated — full company profile →

Who can join

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

Sponsor's own description

The purpose of this study is to evaluate the relative bioavailability of a fixed-dose combination tablet (FDC) of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del).
Heneghan M, Southern KW, Murphy J, Sinha IP, et al · · 2023 · cited 10× · PMID 37983082 · DOI 10.1002/14651858.cd010966.pub4

Verify or expand the search:

Other trials of VX-121/TEZ/D-IVA

Trials testing the same drug.

NCT05444257 — A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy · Phase 3 · active not recruiting
NCT05437120 — Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairme · Phase 1 · completed
NCT05422222 — Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age · Phase 3 · recruiting
NCT05076149 — A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozy · Phase 3 · completed
NCT05033080 — A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a M · Phase 3 · completed

Other recruiting trials for Cystic Fibrosis

Currently open trials in the same condition.

NCT07437105 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants · Phase 1 · recruiting
NCT07283770 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants · Phase 1 · recruiting
NCT07274631 — A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine · recruiting
NCT06810167 — Assessing Tenapanor as a Treatment of CF-related Constipation. · Phase 3 · recruiting
NCT06962852 — A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI · Phase 1, PHASE2 · active not 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 NCT05535959 (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: 12 December 2022

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/NCT05535959.

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