A Study to Evaluate the Effect of Gastric pH on Acalabrutinib Pharmacokinetics (PK) in Healthy Adult Participants

Study identifier:ACE-HV-113

ClinicalTrials.gov identifier:NCT04905043

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Single-center, Open-label, Fixed-sequence, 2-period Study in Healthy Adult Subjects to Evaluate the Effect of Gastric pH on Acalabrutinib Pharmacokinetics

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Acalabrutinib, SmartPill®

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 03 Jun 2016

Primary Completion Date: 11 Jul 2016

Study Completion Date: 11 Jul 2016

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2021 by Acerta Pharma BV

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Continuous nonsmoker who has not used nicotine-containing products for >= 3 months before the first dose.
- Body mass index (BMI) >= 18.0 and <= 32.0 kg/m^2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the principal investigator. Liver function tests, and serum bilirubin, must be <= upper limit of normal range (ULN) at screening.
- Minimum of 1 bowel movement per day for >= 3 months before enrollment.
- Women must be of non-childbearing status and must have negative serum pregnancy test results.
- Men of reproductive potential to follow protocol defined contraception methods.

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.
- Participant has any of the following contraindications for the SmartPill: A history of gastric bezoars, swallowing disorder, suspected or known strictures, fistulas or physiological/mechanical gastrointestinal (GI) obstruction, history of GI surgery within 3 months of administration, severe dysphagia to food or pills, Crohn’s disease or diverticulitis, cardiac pacemakers or other implanted electromedical devices.
- History or presence of alcoholism or drug abuse within the past 2 years before screening
- History of bleeding diathesis
- History of gastric motility disorder for example delayed gastric emptying, dumping syndrome, or irritable bowel disease.
- History of constipation within the last year before enrollment
- Currently experiencing, or experienced within 2 weeks of enrollment, Grade 2 diarrhea
- Women who are pregnant or breastfeeding
- Positive urine drug or alcohol results at screening or check-in
- Positive urine cotinine at screening.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Seated blood pressure is < 90/40 mmHg or > 140/90 mmHg at screening.
- Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
- Have been on a diet incompatible with the on study diet, in the opinion of the principal investigator (PI), within the 28 days before the first dose of study drug, and throughout the study.
- Unable to refrain from or anticipates the use of protocol defined medications.
- History or presence of liver disease and clostridium difficile-associated diarrhea.
-

No locations available

Arms	Assigned Interventions
Experimental: SmartPill® + Acalabrutinib Participants will receive 1 SmartPill® capsule followed immediately by a single oral dose of acalabrutinib 100 mg capsule on Day 1 (Period 1) and Day 4 (Period 2). There will be 72 hours of washout between acalabrutinib dosing of each period.	-

Documents available

ACE-HV-113 CSR Synopsis_redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Cinical Study Information Center

1-877-240-9479

[email protected]