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

Study identifier:ACE-HV-009

ClinicalTrials.gov identifier:NCT04898101

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Acalabrutinib, Microtracer [14C]ACP-196

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 03 Mar 2016

Primary Completion Date: 13 Apr 2016

Study Completion Date: 13 Apr 2016

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2021 by Acerta Pharma BV

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Continuous non-smoker who has not used nicotine-containing products within 3 months before Check-in and during the entire study
- Body mass index (BMI) >= 18.5 to <= 29.9 kg/m^2 at Screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the investigator
- Women must be of non-childbearing status and have negative serum pregnancy test results at Screening and Check-in
- Male participants must be willing to use protocol specified contraception methods
- A minimum of 1 bowel movement per day (Cohort 2 only)

Exclusion Criteria

- Participant is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
- History of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study
- Presence of any clinically significant, ongoing systemic bacterial, fungal, or viral infections in the opinion of the investigator
- History or presence of alcoholism or drug abuse within the past 2 years before Screening
- History of bleeding diathesis
- Any clinically significant condition that may affect acalabrutinib absorption in the opinion of the investigator, including gastric restrictions and bariatric surgery (eg, gastric bypass)
- History or presence of clinically significant thyroid disease, in the opinion of the investigator
- Women who are pregnant, breastfeeding, or lactating
- Positive test for selected drugs of abuse at Screening and at Check-in
- Known history of human immunodeficiency virus (HIV), serologic status reflecting active or past history of hepatitis B or C infection, or any uncontrolled active systemic infection
- Supine blood pressure is < 90/40 mmHg or > 140/90 mmHg at Screening
- Supine pulse is < 40 beats per minute or > 99 beats per minute at Screening
- Have been on a diet incompatible with the on-study diet, in the opinion of the Investigator, within the 28 days before the dose of study drug, and throughout the study
- Unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications
- Participation in more than 1 other radiolabeled investigational study drug trial within 12 months before Check-in
- Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal) or current employment in a job requiring radiation exposure monitoring, with either being within 12 months before Check-in
- Poor peripheral venous access
- Unwilling to consume trace amounts of ethanol (alcohol) that may be present in the dose formulation
- History or presence of liver disease or cholecystectomy and Clostridium difficile associated diarrhea

No locations available

Arms	Assigned Interventions
Experimental: Cohort 1 Participants will receive a single 100 mg oral capsule dose of acalabrutinib and at 58 minutes postdose, participants will receive a single microtracer (<10 μg; <=1 μCi) [14C]ACP-196 as a 5 mL IV push over 2 minutes.	Drug: Acalabrutinib Participants in Cohort 1 will receive a single 100 mg oral capsule dose of acalabrutinib on Day 1. Other Name: ACP-196 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.
Experimental: Cohort 2 Participants 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.	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.

Arms

Assigned Interventions

Experimental: Cohort 1
Participants will receive a single 100 mg oral capsule dose of acalabrutinib and at 58 minutes postdose, participants will receive a single microtracer (<10 μg; <=1 μCi) [14C]ACP-196 as a 5 mL IV push over 2 minutes.

Drug: Acalabrutinib
Participants in Cohort 1 will receive a single 100 mg oral capsule dose of acalabrutinib on Day 1.

Other Name: ACP-196

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.

Experimental: Cohort 2
Participants 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.

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

Priti Patel

Investigators

Principal Investigator