Trials / Terminated
TerminatedNCT04497948
Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19
An Open-label, Multiple-dose Study of Acalabrutinib, Co Administered With a Proton-pump Inhibitor, in Participants Hospitalized With COVID-19
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Acerta Pharma BV · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
Study D822FC00005 will investigate the Phamacokinetics, Safety and tolerability of Acalabrutinib suspension when delivered via a nasogastric tube and co-administered with a Proton Pump Inhibitor, in the treatment of COVID-19.
Detailed description
This study is to support the ongoing clinical development of acalabrutinib (CALQUENCE®) in hospitalized COVID-19 patients. Because many COVID-19 patients may be unable to swallow capsules due to respiratory failure (eg, they may require endotracheal intubation for ventilator support and Naso Gastric tube placement), it is important to have a clinically acceptable method to administer acalabrutinib (capsules) via NG tube. Furthermore, many hospitalized patients are placed on high doses of proton pump inhibitors (PPIs) (also commonly known as antacid medication). This study is designed to determine the Pharmaco Kinetics (effect of body/ bodily systems on the drug), safety and tolerability of acalabrutinib suspension, when coadministered with a PPI, in participants with confirmed SARS-CoV-2 infection requiring hospitalization due to respiratory failure, attributable to COVID-19 pneumonia and who have an Nasogastric (NG) tube in place.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acalabrutinib | Acalabrutinib (CALQUENCE®) is a covalent BTK inhibitor |
Timeline
- Start date
- 2020-09-21
- Primary completion
- 2020-11-18
- Completion
- 2020-11-18
- First posted
- 2020-08-04
- Last updated
- 2021-11-17
- Results posted
- 2021-11-05
Locations
4 sites across 1 country: Brazil
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04497948. Inclusion in this directory is not an endorsement.