A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, Food Effects, and Drug-drug Interactions of ACP-196 in Healthy Participants

• Status: Completed
• Trial end date: 2014-05-22
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the safety, pharmacokinetics/pharmacodynamics (PK/PD), food-effect, and drug-drug interaction study of ACP-196 in healthy participants.

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

Details

• Lead Sponsor: Acerta Pharma BV
• Treatments: Acalabrutinib; Itraconazole

Criteria

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.