Correlated Drug Terms (4)

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	Name (Synonyms)	Correlation
drug109	Acalabrutinib Treatment B Wiki	1.00
drug110	Acalabrutinib Treatment C Wiki	1.00
drug1374	Losartan Wiki	0.35
drug1822	Placebo Wiki	0.06

Correlated MeSH Terms (7)

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	Name (Synonyms)	Correlation
D055371	Acute Lung Injury NIH	0.10
D012127	Respiratory Distress Syndrome, Newborn NIH	0.10
D012128	Respiratory Distress Syndrome, Adult NIH	0.09
D003141	Communicable Diseases NIH	0.09
D007239	Infection NIH	0.06
D045169	Severe Acute Respiratory Syndrome NIH	0.05
D018352	Coronavirus Infections NIH	0.04

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: To compare the AUCinf of the acala NG suspension with and without rabeprazole. To compare the AUC of the acala NG suspension with the oral capsule.

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: Area under plasma concentration-time curve from time zero to infinity (AUCinf)

Time: Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours (h) post-dose

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Description: To compare the AUClast of the acala NG suspension with and without rabeprazole. To compare the AUClast of the acala NG suspension with the oral capsule.

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast)

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

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Description: To compare the Cmax of the acala NG suspension with and without rabeprazole. To compare the Cmax of the acala NG suspension with the oral capsule.

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: Maximum observed plasma concentration (Cmax)

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

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Secondary Outcomes

Description: To compare the AUC0-24 of the acala NG suspension with and without rabeprazole. To compare the AUC0-24 of the acala NG suspension with the oral capsule.

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)

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

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Description: To compare the tmax of the acala NG suspension with and without rabeprazole. To compare the tmax of the acala NG suspension with the oral capsule.

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: Time to reach maximum observed plasma concentration (tmax)

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

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Description: To compare the t1/2 of the acala NG suspension with and without rabeprazole. To compare the t1/2 of the acala NG suspension with the oral capsule.

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2)

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

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Description: To compare the MRT of the acala NG suspension with and without rabeprazole. To compare the MRT of the acala NG suspension with the oral capsule.

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: Mean residence time of the drug in the systemic circulation from zero to infinity (MRT)

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

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Description: To compare the λz of the acala NG suspension with and without rabeprazole. To compare the λz of the acala NG suspension with the oral capsule.

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: Terminal elimination rate constant (λz)

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

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Description: To compare the CL/F of the acala NG suspension with and without rabeprazole. To compare the CL/F of the acala NG suspension with the oral capsule.

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: Apparent total body clearance of drug from plasma after extravascular administration (acalabrutinib only) (CL/F)

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

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Description: To compare the Vz/F of the acala NG suspension with and without rabeprazole. To compare the Vz/F of the acala NG suspension with the oral capsule.

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: Apparent volume of distribution during the terminal phase after extravascular administration (acalabrutinib only) (Vz/F)

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

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Description: To compare the M:P[AUC] of the acala NG suspension with and without rabeprazole. To compare the M:P[AUC] of the acala NG suspension with the oral capsule.

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: Metabolite to parent ratio based on AUCinf and/or AUClast (M:P[AUC])

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

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Description: To compare the M:P[Cmax] of the acala NG suspension with and without rabeprazole. To compare the M:P[Cmax] of the acala NG suspension with the oral capsule.

Measure: Acalabrutinib and ACP-5862 plasma PK parameter: Metabolite to parent ratio based on Cmax (M:P[Cmax])

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

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Description: To assess the safety and tolerability of single doses of acalabrutinib suspension in healthy participants.

Measure: Number of subjects with abnormal vital signs

Time: Screening, Day -1, and Day 2

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Description: To assess the safety and tolerability of single doses of acalabrutinib suspension in healthy participants.

Measure: Number of subjects with abnormal laboratory assessments

Time: Screening, Day -1, Days 1-2, and follow-up visit (7-10 days after last dose)

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Description: To assess the safety and tolerability of single doses of acalabrutinib suspension in healthy participants.

Measure: Number of subjects with serious and non-serious adverse events

Time: Screening (Day -28), Days -3, -2, -1, Days 1-3, and follow-up visit (7-10 days after last dose)

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