Last reviewed · How we verify
NCT03942666
PK Linearity and Steady State PK of CHF 6532 in Healthy Subjects
Phase 1 trial testing Treatment A in Asthma in 30 participants. Completed in 22 November 2019.
22 November 2019
Quick facts
| Lead sponsor | Chiesi Farmaceutici S.p.A. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 30 |
| Start date | 10 May 2019 |
| Primary completion | 22 November 2019 |
| Estimated completion | 22 November 2019 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Treatment A (treatment-a) — full drug profile →
- Treatment B (treatment-b) — full drug profile →
- Treatment C (treatment-c) — full drug profile →
- Treatment D (treatment-d) — full drug profile →
- Treatment E
- Treatment F — full drug profile →
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
Chiesi Farmaceutici S.p.A. — full company profile →
Who can join
Adults 18 to 60, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this clinical pharmacology study is to evaluate the CHF 6532 linearity after single oral administrations of four doses of a tablet formulation and to evaluate the pharmacokinetic (PK) at steady state following the repeated open label b.i.d. administration at one dose.
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 NCT03942666
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Treatment A
Trials testing the same drug.
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- NCT06693518 — A Study to Learn About if the Study Medicine Called Ibuzatrelvir Changes How the Body Process the Other Medicine Dabigat · Phase 1 · completed
- NCT05868356 — A PK Study to Assess the Drug-drug Interaction of a Strong CYP2C8 Inhibitor on Adagrasib · Phase 1 · completed
- NCT07214922 — Relative Bioavailability of Evobrutinib Tablet Batches · Phase 1 · completed
Other recruiting trials for Asthma
Currently open trials in the same condition.
- NCT07525375 — A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared t · Phase 2 · recruiting
- NCT07536256 — Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being · NA · recruiting
- NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
- NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
- NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting
Other Chiesi Farmaceutici S.p.A. trials
Trials by the same sponsor.
- NCT07516951 — A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis · Phase 2 · not yet recruiting
- NCT07301736 — Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma · Phase 2 · recruiting
- NCT07163182 — Evaluation of Safety, Side Effects and How the Drug CHF6467 Administered Via Intranasal Route is Absorbed, Modified and · Phase 1 · recruiting
- NCT06900816 — A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate C · Phase 2 · completed
- NCT06892756 — Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. · 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 NCT03942666 (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 Chiesi Farmaceutici S.p.A.
- Last refreshed: 22 July 2020
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/NCT03942666.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing