Status:
COMPLETED
A Study to Evaluate the Effect of [14C]Acp-196 (Acalabrutinib) in Healthy Adult Participants
Lead Sponsor:
Acerta Pharma BV
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is to determine the absolute bioavailability of oral acalabrutinib and intravenous (IV) PK of \[14C\]ACP-196.
Detailed Description
This is 2-cohort study. Screening period will be within 28 days before the dose. In the treatment period, participants in Cohort 1 will receive a single 100 mg oral capsule dose of acalabrutinib and a...
Eligibility Criteria
Inclusion
- Continuous non-smoker who has not used nicotine-containing products within 3 months before Check-in and during the entire study
- Body mass index (BMI) \>= 18.5 to \<= 29.9 kg/m\^2 at Screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the investigator
- Women must be of non-childbearing status and have negative serum pregnancy test results at Screening and Check-in
- Male participants must be willing to use protocol specified contraception methods
- A minimum of 1 bowel movement per day (Cohort 2 only)
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
- History of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study
- Presence of any clinically significant, ongoing systemic bacterial, fungal, or viral infections in the opinion of the investigator
- History or presence of alcoholism or drug abuse within the past 2 years before Screening
- History of bleeding diathesis
- Any clinically significant condition that may affect acalabrutinib absorption in the opinion of the investigator, including gastric restrictions and bariatric surgery (eg, gastric bypass)
- History or presence of clinically significant thyroid disease, in the opinion of the investigator
- Women who are pregnant, breastfeeding, or lactating
- Positive test for selected drugs of abuse at Screening and at Check-in
- Known history of human immunodeficiency virus (HIV), serologic status reflecting active or past history of hepatitis B or C infection, or any uncontrolled active systemic infection
- Supine blood pressure is \< 90/40 mmHg or \> 140/90 mmHg at Screening
- Supine pulse is \< 40 beats per minute or \> 99 beats per minute at Screening
- Have been on a diet incompatible with the on-study diet, in the opinion of the Investigator, within the 28 days before the dose of study drug, and throughout the study
- Unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications
- Participation in more than 1 other radiolabeled investigational study drug trial within 12 months before Check-in
- Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal) or current employment in a job requiring radiation exposure monitoring, with either being within 12 months before Check-in
- Poor peripheral venous access
- Unwilling to consume trace amounts of ethanol (alcohol) that may be present in the dose formulation
- History or presence of liver disease or cholecystectomy and Clostridium difficile associated diarrhea
Key Trial Info
Start Date :
March 3 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2016
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04898101
Start Date
March 3 2016
End Date
April 13 2016
Last Update
May 24 2021
Active Locations (1)
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1
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, United States, 53704