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NCT05306379: Statin-DDI
Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin
Phase 1 trial testing Simvastatin in Drug-drug Interaction in 24 participants. Completed in 5 April 2022.
5 April 2022
Quick facts
| Lead sponsor | Aurinia Pharmaceuticals Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 24 |
| Start date | 24 January 2022 |
| Primary completion | 5 April 2022 |
| Estimated completion | 5 April 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Simvastatin (simvastatin) — full drug profile →
- Voclosporin — full drug profile →
Conditions studied
- Drug-drug Interaction — all drugs for Drug-drug Interaction →
Sponsor
Aurinia Pharmaceuticals Inc. — full company profile →
Who can join
Adults 18 to 55, any sex, with Drug-drug Interaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A single-center, open-label, Phase 1, drug-drug interaction study to investigate the effect of voclosporin on the pharmacokinetics of simvastatin and simvastatin acid in healthy volunteers.
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 NCT05306379
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Drug-drug Interaction
Currently open trials in the same condition.
- NCT06381375 — Drug-drug Interactions With Anti-tuberculous Drugs · recruiting
- NCT06682325 — Pharmaco-proteomic Platform to Evaluate Drug Interactions in Liver Transplant Patients · recruiting
- NCT05044962 — Kuwa Free! - Live Free! · NA · recruiting
Other Aurinia Pharmaceuticals Inc. trials
Trials by the same sponsor.
- NCT05962788 — Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis · Phase 3 · terminated
- NCT05288855 — Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis · Phase 3 · terminated
- NCT05337124 — A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US · completed
- NCT04147650 — Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrom · Phase 2, PHASE3 · completed
- NCT03597464 — Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin · Phase 3 · 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 NCT05306379 (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 Aurinia Pharmaceuticals Inc.
- Last refreshed: 20 April 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/NCT05306379.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing