A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, Food Effects, and Drug-drug Interactions of ACP-196 in Healthy Participants
Status and phase
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Treatments
Details and patient eligibility
About
This study is to evaluate the safety, pharmacokinetics/pharmacodynamics (PK/PD), food-effect, and drug-drug interaction study of ACP-196 in healthy participants.
Full description
The study is divided into 3 parts. Part 1 will include 5 cohorts (Cohorts [C] 1 to 5) and participants will receive oral ACP-196 2.5 to 50 mg twice daily (BID) and 100 mg once daily (QD) on Day 1. In Part 2 (Cohort 6), participants will receive a single oral dose of 75.0 mg QD in a fasting and a fed state, with a 7-day washout period between the 2 doses. In Part 3 (Cohort 7), participants will receive a single oral dose of 50.0 mg QD alone on Day 1 and in combination with itraconazole on Day 9. Itraconazole 200 mg will be given twice daily (12 hours apart) with meals on Days 4 to 8 and once on Day 9 with ACP-196 under a fasting state in the morning.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Body mass index (BMI) >=18.0 and <=30.0 kg/m^2.
- Healthy as determined by medical history and physical examination.
- Nonsmoker
- Normal clinical laboratory test results and ECG, or results with minor deviations which are not considered to be clinically significant in the judgment of the investigator.
- Men of and women of childbearing potential to follow protocol defined contraception methods.
- Women must have negative urine pregnancy test.
- Willingness and ability to swallow study drug capsules.
Exclusion criteria
- Prior or ongoing clinically significant illness, medical condition, medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the subject; alter the absorption, distribution, metabolism, or excretion of the study drug; or impair the assessment of study results.
- Evidence of ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections).
- Women cannot be pregnant or breast feeding.
- Significant history of drug or alcohol abuse or addiction within 3 years before study screening or as evidenced by continuing medical complications of prior drug or alcohol use.
- History of blood or plasma donation within 90 days before first study drug administration.
- Currently drinking over 21 units/week of ethanol
- Drug toxicology screen positive for any prohibited drugs, illicit substances, or alcohol.
- Anticipated need for alcohol, tobacco, or any drug during the study drug administration and immediate follow-up periods.
- Relative to admission has any of the following exposures: has taken a prescription systemic medication within 14 days; has used an over-the counter systemic medication (other than acetaminophen) within 7 days; has ingested calcium supplements or calcium-containing vitamins within 7 days; has ingested grapefruit, grapefruit juice, or grapefruit-containing products within 7 days; has consumed alcohol within 48 hours; has taken acetaminophen within 24 hours.
- Positive test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen or hepatitis B core antibody, or hepatitis C antibody.
- Unwillingness to avoid vigorous physical activity during inpatient clinic confinements.
- Part 2 only - Inability or unwillingness to eat all of the ingredients of the high-fat, high-calorie meal as specified in the protocol.
- Part 3 only - Known allergy to itraconazole or other azole compounds.
Trial design
Primary purpose
Allocation
Interventional model
Masking
59 participants in 7 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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