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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT04905043

Run by

Acerta Pharma BV

People needed

12

Starts

2016-06-03

Expected to finish

2016-07-11

Last updated by the study team

2021-06-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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