NCT04898101

A Study to Evaluate the Effect of [14C]Acp-196 (Acalabrutinib) in Healthy Adult Participants

Absolute Bioavailability, Pharmacokinetics, Excretion, and Metabolism of [14C]Acp-196 (Acalabrutinib) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Acerta Pharma BV · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is to determine the absolute bioavailability of oral acalabrutinib and intravenous (IV) PK of \[14C\]ACP-196.

Detailed description

This is 2-cohort study. Screening period will be within 28 days before the dose. In the treatment period, participants in Cohort 1 will receive a single 100 mg oral capsule dose of acalabrutinib and at 58 minutes postdose of acalabrutinib will receive a single microtracer (\<10 μg; \<=1 μCi) \[14C\]ACP-196 as a 5 mL IV push over 2 minutes; and participants in Cohort 2 will receive a single 100 mL oral solution of acalabrutinib (1 mg/mL oral solution containing a microtracer dose (\<10 μg; \<=1 μCi) of \[14C\]ACP-196). Cohort 1 participants will be confined continuously from Check-in until Day 5 and Cohort 2 participants will be confined continuously from Check-in until Day 8.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Acalabrutinib	Participants in Cohort 1 will receive a single 100 mg oral capsule dose of acalabrutinib on Day 1.
DRUG	Microtracer [14C]ACP-196	Participants in Cohort 1 will receive a single microtracer (\<10 μg; ≤1 μCi) IV solution dose of \[14C\]ACP-196 as a 5-mL IV push over 2 minutes on Day 1. Participants in Cohort 2 will receive a single 100 mL dose of acalabrutinib 1 mg/mL oral solution containing a microtracer dose (\<10 μg; ≤1 μCi) of \[14C\]ACP-196 on Day 1.

Timeline

• Start date: 2016-03-03
• Primary completion: 2016-04-13
• Completion: 2016-04-13
• First posted: 2021-05-24
• Last updated: 2021-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study