Study identifier:ACE-HV-113
ClinicalTrials.gov identifier:NCT04905043
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1, Single-center, Open-label, Fixed-sequence, 2-period Study in Healthy Adult Subjects to Evaluate the Effect of Gastric pH on Acalabrutinib Pharmacokinetics
Healthy Volunteers
Phase 1
Yes
Acalabrutinib, SmartPill®
All
12
Interventional
18 Years - 65 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2021 by Acerta Pharma BV
Acerta Pharma BV
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This study will evaluate the effect of gastric pH on acalabrutinib pharmacokinetics in healthy participants.
This is a 2-period study done under fasting conditions. Participants will receive an oral wireless motility/pH capsule (SmartPill®) followed immediately by a single 100 mg oral dose of acalabrutinib on Day 1 of Period 1 and Period 2 (ie, Day 1 and Day 4, respectively). There will be 72 hours of washout between Day 1 dosing of each period. Participants will be contacted approximately 14 days after the last dose of study drug for adverse events.
Location
Location
Tempe, Arizona, United States, 85283
Arms | Assigned Interventions |
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Experimental: SmartPill® + Acalabrutinib Participants will receive 1 SmartPill® capsule followed immediately by a single oral dose of acalabrutinib 100 mg capsule on Day 1 (Period 1) and Day 4 (Period 2). There will be 72 hours of washout between acalabrutinib dosing of each period. | - |
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