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AcalabrutinibWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (7)

Name (Synonyms) Correlation
drug1363 IP-10 in CDS protocol Wiki 0.50
drug2358 Rabeprazole Wiki 0.50
drug2252 Prone positioning (PP) Wiki 0.50
drug3278 high flow nasal cannula (HFNC) Wiki 0.50
drug870 Dexamethasone Wiki 0.20
drug1284 Hydroxychloroquine Wiki 0.05
drug2122 Placebo Wiki 0.03

Correlated MeSH Terms (8)

Name (Synonyms) Correlation
D055371 Acute Lung Injury NIH 0.14
D012127 Respiratory Distress Syndrome, Newborn NIH 0.14
D012128 Respiratory Distress Syndrome, Adult NIH 0.12
D045169 Severe Acute Respiratory Syndrome NIH 0.07
D011024 Pneumonia, Viral NIH 0.06
D018352 Coronavirus Infections NIH 0.06
D003141 Communicable Diseases NIH 0.04
D007239 Infection NIH 0.03

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There are 4 clinical trials

Clinical Trials

1 A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of Acalabrutinib With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19

CALAVI will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.

NCT04346199 COVID-19 Drug: Acalabrutinib

Primary Outcomes

Description: Respiratory failure, is defined based on resource utilization of any of the following modalities: Endotracheal intubation and mechanical ventilation Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5) Noninvasive positive pressure ventilation or continuous positive airway pressure Extracorporeal membrane oxygenation

Measure: Subject alive and free of respiratory failure

Time: Day 14

Secondary Outcomes

Measure: Proportion of subjects alive and free of respiratory failure

Time: Day 28

Measure: Percent change from baseline in CRP

Time: Days 3, 5, 7, 10, 14, 28

Measure: Change from baseline in ferritin

Time: Days 3, 5, 7, 10, 14, 28

Measure: Chnage from baseline in absolute lymphocyte counts

Time: Days 3, 5, 7, 10, 14, 28

Measure: All cause mortality

Time: Day 90

Measure: Proportion of subjects alive and discharged from ICU

Time: Days 14 and 28

Measure: Time from randomization to first occurrence of respiratory failure or death on study due to any cause

Time: Up to 28 days after randomization

Measure: Number of days alive and free of respiratory failure

Time: To 28 days after randomization

Measure: Number of days with respiratory failure

Time: to 28 days after randomization

Measure: Number of days hospitalized

Time: To 28 days after randomization

Measure: Number of days in ICU (length of stay)

Time: To 90 days after randomization

Measure: Number of days alive outside of hospital

Time: To 28 days after randomization

Measure: Number of days alive outside of hospital

Time: To 90 days after randomization

Measure: Relative change from baseline in oxygenation index (PaO2/FiO2)

Time: To Day 5

Description: Type, frequency, severity, and relationship to study treatment of any TEAEs or abnormalities of laboratory tests, SAEs, or AEs leading to discontinuation of study treatment.

Measure: Occurrence of Adverse Events and Serious Adverse Events

Time: 28 days after last dose

Description: Peak Plasma Concentration (Cmax)

Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (Cmax)

Time: 28 days after last dose

Description: Time to Maximum Concentration (Tmax)

Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (Tmax)

Time: 28 days after last dose

Description: Area under the plasma concentration versus time curve (AUC)

Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (AUC)

Time: 28 days after last dose

2 A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of Acalabrutinib With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19

CALAVI US will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.

NCT04380688 COVID-19 Drug: Acalabrutinib

Primary Outcomes

Description: Type, frequency, severity, and relationship to study treatment of any TEAEs or abnormalities of laboratory tests, SAEs, or AEs leading to discontinuation of study treatment.

Measure: Occurrence of Adverse Events and Serious Adverse Events

Time: Day 14

Description: Respiratory failure, is defined based on resource utilization of any of the following modalities: Endotracheal intubation and mechanical ventilation Oxygen delivered by highflow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5) Noninvasive positive pressure ventilation or continuous positive airway pressure Extracorporeal membrane oxygenation

Measure: Subject alive and free of respiratory failure

Time: Day 28

Secondary Outcomes

Measure: Proportion of subjects alive and free of respiratory failure

Time: Day 28

Measure: Percent change from baseline in CRP

Time: Days 3, 5, 7, 10, 14, 28

Measure: Change from baseline in ferritin

Time: Days 3, 5, 7, 10, 14, 28

Measure: Change from baseline in absolute lymphocyte counts

Time: Days 3, 5, 7, 10, 14, 28

Measure: All cause mortality

Time: Day 90

Measure: Proportion of subjects alive and discharged from ICU

Time: Days 14 and 28

Measure: Time from randomization to first occurrence of respiratory failure or death on study due to any cause

Time: Up to 28 days after randomization

Measure: Number of days alive and free of respiratory failure

Time: Up to 28 days after randomization

Measure: Number of days with respiratory failure

Time: Up to 28 days after randomization

Measure: Number of days hospitalized

Time: Up to 28 days after randomization

Measure: Number of days in ICU (length of stay)

Time: Up to 90 days after randomization

Measure: Number of days alive outside of hospital

Time: Up to 28 days after randomization

Measure: Number of days alive outside of hospital

Time: Up to 90 days after randomization

Measure: Relative change from baseline in oxygenation index (SpO2/FiO2)

Time: Days 3, 5, 7, and 10

Measure: Time to clinical improvement of at least 2 points (from randomization) on a 9-point category ordinal scale

Time: Up to 28 days after randomization

Measure: Time to SpO2 > 94% on room air

Time: Up to 28 days after randomization

Description: Plasma concentrations of acalabrutinib and ACP-5862

Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862

Time: Days 3 and 7

3 A Phase I, Open-label, Randomized, Single-dose Study of Acalabrutinib in Healthy Subjects to Evaluate the Effect of Proton-pump Inhibitor (Rabeprazole) on Acalabrutinib Capsule When Administered Orally With COCA-COLA

This study is being conducted to support the clinical development of acalabrutinib in participants who need treatment with proton pump inhibitors while taking acalabrutinib.

NCT04489797 Infectious Disease Drug: Acalabrutinib Drug: Rabeprazole
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Assessment of AUCinf for acalabrutinib and ACP-5862 (metabolite of acalabrutinib) following administration of capsule with and without rabeprazole.

Measure: Area under plasma concentration-time curve from time zero to infinity (AUCinf)

Time: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2

Description: Assessment of AUClast for acalabrutinib and ACP-5862 following administration of capsule with and without rabeprazole.

Measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast)

Time: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2

Description: Assessment of Cmax for acalabrutinib and ACP-5862 following administration of capsule with and without rabeprazole.

Measure: Maximum observed plasma concentration (Cmax)

Time: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2

Secondary Outcomes

Description: Assessment of the safety and tolerability of acalabrutinib capsule when administered with COCA-COLA and rabeprazole.

Measure: Number of participants with adverse events and serious adverse events

Time: From screening until Follow-up visit (Upto 5 to 6 Weeks)

4 An Open-label, Multiple-dose Study of Acalabrutinib, Co Administered With a Proton-pump Inhibitor, in Participants Hospitalized With COVID-19

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.

NCT04497948 COVID-19 Drug: Acalabrutinib

Primary Outcomes

Description: To assess the AUC12h (area under plasma concentration-time curve from time zero to 12 hours) of the acalabrutinib NG suspension when coadministered with the PPI in participants with COVID-19

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: AUC12h

Time: Pre-dose and 0.5, 1, 2, 4, 6, and 12 hours post-dose

Description: To assess the AUClast (area under the plasma concentration-time curve from time zero to time of last quantifiable concentration) of the acalabrutinib NG suspension when coadministered with the PPI in participants with COVID-19

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: AUClast

Time: Pre-dose and 0.5, 1, 2, 4, 6, and 12 hours post-dose

Description: To assess the Cmax (maximum observed plasma concentration) of the acalabrutinib NG suspension when coadministered with the PPI in participants with COVID-19

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: Cmax

Time: Pre-dose and 0.5, 1, 2, 4, 6, and 12 hours post-dose

Description: To Assess Safety and tolerability of acalabrutinib suspension in participants with COVID-19 when administered in the presence of PPIs and BSC

Measure: Type, frequency, severity, and relationship to study intervention of any treatment-emergent AEs or abnormalities of laboratory tests, SAEs, or AEs leading to discontinuation of study intervention

Time: From screening to 28 days (+/- 3days) after last dose of acalabrutinib

Secondary Outcomes

Description: To evaluate the preliminary efficacy of adding acalabrutinib suspension to BSC for treatment of participants with COVID-19

Measure: Proportion of participants alive and free of respiratory failure at Days 14 and 28

Time: 28 Days

Description: To evaluate the preliminary efficacy of adding acalabrutinib suspension to BSC for treatment of participants with COVID-19

Measure: Percent change from baseline in CRP at Days 3, 5, 7, 14, 28

Time: Baseline and Days 3, 5, 7, 14, 28

Description: To evaluate the preliminary efficacy of adding acalabrutinib suspension to BSC for treatment of participants with COVID-19

Measure: Time to improvement- clinical improvement of ≥ 2 points(from first dose date)on a 9-point category ordinal scale Or live discharge from the hospital Or considered fit for discharge(a score of 0,1,or2 on the ordinal scale)whichever comes first,by Day 28

Time: Up to Day 28

No related HPO nodes (Using clinical trials)