Status:
COMPLETED
A Study to Evaluate the Effect of Gastric pH on Acalabrutinib Pharmacokinetics (PK) in Healthy Adult Participants
Lead Sponsor:
Acerta Pharma BV
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will evaluate the effect of gastric pH on acalabrutinib pharmacokinetics in healthy participants.
Detailed 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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 3 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04905043
Start Date
June 3 2016
End Date
July 11 2016
Last Update
June 3 2021
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283