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

NCT04898101 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-05-24

No results posted yet for this study

Summary

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

Conditions

  • Healthy Volunteers

Interventions

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.

Sponsors & Collaborators

  • Acerta Pharma BV

    lead INDUSTRY

Principal Investigators

  • Priti Patel · Acerta Pharma BV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-03
Primary Completion
2016-04-13
Completion
2016-04-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04898101 on ClinicalTrials.gov