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

• Status: Completed
• Trial end date: 2016-07-11
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Acerta Pharma BV
• Treatments: Acalabrutinib

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.