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NCT05867147
An Electrocardiogram Study to Evaluate the Effect of Vanzacaftor on the QT/QTc Interval in Healthy Participants
Phase 1 trial testing Vanzacaftor in Cystic Fibrosis in 56 participants. Completed in 14 June 2023.
14 June 2023
Quick facts
| Lead sponsor | Vertex Pharmaceuticals Incorporated |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 26 April 2023 |
| Primary completion | 14 June 2023 |
| Estimated completion | 14 June 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Vanzacaftor (VANZACAFTOR) — full drug profile →
- Vanzacaftor Placebo — full drug profile →
- Moxifloxacin (moxifloxacin) — full drug profile →
- Moxifloxacin Placebo — 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 45, 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 effect of Vanzacaftor (VNZ) on QTcF, as well as the pharmacokinetic (PK), safety, and tolerability of VNZ in healthy participants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05867147
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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)
- Trial protocol + status: ClinicalTrials.gov NCT05867147 (US National Library of Medicine, public domain)
- 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: 14 July 2023
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/NCT05867147.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing