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NCT04564040

A Study in Healthy Subjects to Assess Bioavailability (Proportion of a Drug Which Enters the Circulation to Have an Active Effect) of Acalabrutinib Tablet and Protonpump Inhibitor Effect (Members of a Class of Medications That Inhibits in Gastric Acid Production) for Rabeprazole

Completed Phase 1 Last updated 29 December 2020
What this trial tests

Phase 1 trial testing Acalabrutinib Treatment A in Mantle Cell Lymphoma in 20 participants. Completed in 11 December 2020.

Timeline
12 October 2020
Primary endpoint
11 December 2020
11 December 2020

Quick facts

Lead sponsorAstraZeneca
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment20
Start date12 October 2020
Primary completion11 December 2020
Estimated completion11 December 2020
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 55, any sex, with Mantle Cell Lymphoma or COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This Phase 1 study is being conducted to support the clinical development of acalabrutinib in hospitalized patients who are unable to swallow acalabrutinib tablet or capsule due to respiratory failure, eg, they may require endotracheal intubation for ventilator support and nasogastric (NG) tube placement, and it is important to have a clinically acceptable method to administer acalabrutinib via NG tube. Part 1 of the study is designed to evaluate relative bioavailability by comparing the pharmacokinetic (PK) of AT suspension in water administered via NG tube with the PK of acalabrutinib capsule suspension in flat COCA-COLA administered via NG tube. Additionally, the PPI effect will be evaluated by comparing the PK of AT suspension in water administered via NG tube plus rabeprazole with the PK of AT suspension in water administered via NG tube. Part 2 of the study is designed to evaluate the effect of NG administration on AT by comparing the PK of AT suspension in water administered via NG tube with the PK of AT orally administered with water.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
    Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
  2. Inflammatory pathways in COVID-19: Mechanism and therapeutic interventions.
    Jiang Y, Zhao T, Zhou X, Xiang Y, et al · · 2022 · cited 44× · PMID 35923762 · DOI 10.1002/mco2.154
  3. Clinical Trials of the BTK Inhibitors Ibrutinib and Acalabrutinib in Human Diseases Beyond B Cell Malignancies.
    Zhu S, Jung J, Victor E, Arceo J, et al · · 2021 · cited 23× · PMID 34778053 · DOI 10.3389/fonc.2021.737943
  4. Molecular Perspectives of SARS-CoV-2: Pathology, Immune Evasion, and Therapeutic Interventions.
    Shah M, Woo HG. · · 2021 · cited 18× · PMID 34059561 · DOI 10.14348/molcells.2021.0026
  5. Chloroquine/hydroxychloroquine: an inflammasome inhibitor in severe COVID-19?
    Bahadoram M, Keikhaei B, Saeedi-Boroujeni A, Mahmoudian-Sani MR. · · 2021 · cited 14× · PMID 33416933 · DOI 10.1007/s00210-020-02034-6
  6. Bioequivalence and Relative Bioavailability Studies to Assess a New Acalabrutinib Formulation That Enables Coadministration With Proton-Pump Inhibitors.
    Sharma S, Pepin X, Burri H, Zheng L, et al · · 2022 · cited 12× · PMID 36029150 · DOI 10.1002/cpdd.1153
  7. Pharmacological strategies to prevent SARS-CoV-2 infection and treat the early phases of COVID-19.
    Scarabel L, Guardascione M, Dal Bo M, Toffoli G. · · 2021 · cited 12× · PMID 33476760 · DOI 10.1016/j.ijid.2021.01.035
  8. Antiviral Immunity in SARS-CoV-2 Infection: From Protective to Deleterious Responses.
    Mihaescu G, Chifiriuc MC, Vrancianu CO, Constantin M, et al · · 2021 · cited 1× · PMID 34946179 · DOI 10.3390/microorganisms9122578

Verify or expand the search:

Other trials of Acalabrutinib Treatment A

Trials testing the same drug.

Other recruiting trials for Mantle Cell Lymphoma

Currently open trials in the same condition.

Other AstraZeneca trials

Trials by the same sponsor.

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