Status:
COMPLETED
A Study to Evaluate the Effect of an Acidic Formulation of Acalabrutinib (ACP-196), Acidic Beverage, or Grapefruit Juice on the Pharmacokinetics (PK) of ACP-196 Alone and Coadministered With Omeprazole
Lead Sponsor:
Acerta Pharma BV
Conditions:
Healthy Volunteers
Eligibility:
All Genders
19-65 years
Phase:
PHASE1
Brief Summary
This study will evaluate the effect of an acidic formulation of Acalabrutinib (ACP-196), acidic beverage, or grapefruit Juice on the PK of ACP-196 alone and coadministered with omeprazole.
Detailed Description
This is a 3-part study. Each part of the study will compare the effect of an acidic formulation of ACP-196, acidic beverage (orange drink), or grapefruit juice on the PK profile of ACP-196 alone and w...
Eligibility Criteria
Inclusion
- Continuous non-smoker 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 electrocardiograms, as deemed by the principal investigator (PI). Liver function tests must be =\< the upper limit of normal range (ULN) at screening for inclusion.
- Men and women of reproductive potential to follow protocol defined contraception methods.
- Women must have negative serum pregnancy test results.
- Willing and able to take the study drug with 240 mL of orange drink (Part 2) or grapefruit juice (Part 3).
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 with known fruit allergies.
- History or presence of clinically significant medical or psychiatric condition or disease (eg, cardiovascular, respiratory, hepatic, gastrointestinal, renal, genitourinary, endocrine, neuromuscular, rheumatologic, oncologic, cutaneous or other disorders), in the opinion of the PI.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- Presence of any clinically significant, ongoing systemic bacterial, fungal or viral infections in the opinion of the PI.
- History or presence of alcoholism or drug abuse within the past 2 years before screening.
- History of bleeding diathesis (eg, hemophilia, von Willebrand disease).
- Any clinically significant condition that may affect acalabrutinib absorption in the opinion of the PI, including gastric restrictions and bariatric surgery (eg, gastric bypass).
- History or presence of clinically significant thyroid disease, in the opinion of the PI.
- 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 mm Hg or \> 140/90 mm Hg at screening.
- Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.
- Have been on a diet incompatible with the on study diet, in the opinion of the 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 medicines:
- Donation of blood or significant blood loss within 56 days before the first dose of study drug.
- Plasma donation within 7 days before the first dose of study drug.
- Prior exposure to acalabrutinib (ACP-196).
- History or presence of clinically significant hypersensitivity or idiosyncratic reaction to acalabrutinib, omeprazole, related compounds (eg, substituted benzimidazoles, other azole compounds), or any inactive ingredients.
- History or presence of liver disease and Clostridium difficile-associated diarrhea.
Key Trial Info
Start Date :
January 28 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2016
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04876807
Start Date
January 28 2016
End Date
March 15 2016
Last Update
May 7 2021
Active Locations (1)
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1
Laura Sterling, MD, MPH
Lincoln, Nebraska, United States, (402) 437-483