Study identifier:D8223C00005
ClinicalTrials.gov identifier:NCT04564040
EudraCT identifier:N/A
CTIS identifier:N/A
A 2-Part, Phase I, Open-label, Single-dose, Sequential, Randomized, Crossover Study of Acalabrutinib Tablet Suspension Delivered via Nasogastric Tube in Healthy Subjects to Evaluate Relative Bioavailability and Proton-pump Inhibitor (Rabeprazole) Effect
Mantle Cell Lymphoma, COVID-19
Phase 1
Yes
Acalabrutinib Treatment A, Acalabrutinib Treatment A, Acalabrutinib Treatment A, Acalabrutinib Treatment A, Acalabrutinib Treatment B, Acalabrutinib Treatment B, Acalabrutinib Treatment B, Acalabrutinib Treatment B, Acalabrutinib Treatment C, Acalabrutinib Treatment C, Acalabrutinib Treatment C, Acalabrutinib Treatment C, Acalabrutinib Treatment D, Acalabrutinib Treatment D, Acalabrutinib Treatment D, Acalabrutinib Treatment D
All
20
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2021 by AstraZeneca
AstraZeneca
Parexel International
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Acalabrutinib Treatment Sequence 1 Part 1: Participants will receive Treatment A (100 mg AT suspension in water via NG administration) in Period 1, Treatment B (100 mg acalabrutinib capsule suspension via NG administration) in Period 2, and Treatment C (100 mg AT suspension in water via NG administration plus 20 mg rabeprazole) in Period 3. Part 2: Participants will receive Treatment D (100 mg AT suspension in water via NG administration) in Period 1 and Treatment A in Period 2. | Drug: Acalabrutinib Treatment A Participants will receive 100 mg AT suspension in water via NG tube. Other Name: AT Drug: Acalabrutinib Treatment B Participants will receive 100 mg acalabrutinib capsule suspension via NG tube. Other Name: Acalabrutinib capsule Drug: Acalabrutinib Treatment C Participants will receive 100 mg AT suspension in water via NG administration plus 20 mg rabeprazole. Other Name: AT and Pariet® (raberprazole) Drug: Acalabrutinib Treatment D Participants will receive 100 mg AT orally. Other Name: AT |
Experimental: Acalabrutinib Treatment Sequence 2 Part 1: Participants will receive Treatment B in Period 1, Treatment A in Period 2, and Treatment C in Period 3. Part 2: Participants will receive Treatment A in Period 1 and Treatment D in Period 2. | Drug: Acalabrutinib Treatment A Participants will receive 100 mg AT suspension in water via NG tube. Other Name: AT Drug: Acalabrutinib Treatment B Participants will receive 100 mg acalabrutinib capsule suspension via NG tube. Other Name: Acalabrutinib capsule Drug: Acalabrutinib Treatment C Participants will receive 100 mg AT suspension in water via NG administration plus 20 mg rabeprazole. Other Name: AT and Pariet® (raberprazole) Drug: Acalabrutinib Treatment D Participants will receive 100 mg AT orally. Other Name: AT |