NCT04768985

Study to Assess the Bioequivalence of Acalabrutinib Tablet and Acalabrutinib Capsule

A Phase I, Open-Label, Randomized, 2-Treatment, 2-Period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of Acalabrutinib Tablet and Acalabrutinib Capsule

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a multicenter, Phase I, open-label, randomized, 2-sequence, 2-treatment, 2-period, crossover, bioequivalence study with single doses of acalabrutinib administered orally in healthy participants. The study is designed to demonstrate the bioequivalence of acalabrutinib tablet (Treatment A) compared with marketed acalabrutinib capsule (Treatment B) in the fasted state.

Detailed description

Eligible healthy participants will be randomized to receive either treatment sequence 1 (AB) or treatment sequence 2 (BA), as follows: * Treatment A: Acalabrutinib tablet, 100 mg, fasted state * Treatment B: Acalabrutinib capsule, 100 mg, fasted state Participants will receive fixed single doses of acalabrutinib on 2 occasions, under fasted conditions. The study will comprise: * Visit 1: A screening period of up to 28 days before first dosing. * Visit 2: Two treatment periods: * Participants will be admitted to the study center on Day -2 of Treatment Period 1 to confirm eligibility before first dosing. Eligibility criteria will be reconfirmed on Day -1 of each treatment period. * On Day 1 of Treatment Periods 1 and 2, participants will be administered the assigned treatment (A or B) as randomized, followed by a protocol defined washout period between Treatment Periods 1 and 2. * Visit 3: A Follow-up Visit/Early Termination Visit at 7 to 10 days after last administration of study drug. Each participant will be involved in the study for approximately 6 weeks.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Treatment A: Acalabrutinib tablet	Participants will receive fixed single doses of acalabrutinib tablet in 2 treatment periods, under fasted conditions.
DRUG	Treatment B: Acalabrutinib capsule	Participants will receive fixed single doses of acalabrutinib capsule in 2 treatment periods, under fasted conditions.

Timeline

• Start date: 2021-02-25
• Primary completion: 2021-05-10
• Completion: 2021-05-10
• First posted: 2021-02-24
• Last updated: 2022-07-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study