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

Acerta Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Acalabrutinib; Drug: SmartPill®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04905043

ACE-HV-113

Details and patient eligibility

About

This study will evaluate the effect of gastric pH on acalabrutinib pharmacokinetics in healthy participants.

Full description

This is a 2-period study done under fasting conditions. Participants will receive an oral wireless motility/pH capsule (SmartPill®) followed immediately by a single 100 mg oral dose of acalabrutinib on Day 1 of Period 1 and Period 2 (ie, Day 1 and Day 4, respectively). There will be 72 hours of washout between Day 1 dosing of each period. Participants will be contacted approximately 14 days after the last dose of study drug for adverse events.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

SmartPill® + Acalabrutinib

Experimental group

Description:

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.

Treatment:

Drug: SmartPill®

Drug: Acalabrutinib