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

NCT ID: NCT04901923

Last Updated: 2021-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-15
• Study Completion Date: 2014-05-22

Brief 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.

Detailed 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.

Conditions

Healthy Participants

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 Cohort 1

Participants will receive ACP-196 2.5 mg capsule orally BID on Day 1.

Group Type: EXPERIMENTAL

ACP-196

Intervention Type: DRUG

Participants will receive ACP-196 oral capsule(s) in all parts.

Part 1 Cohort 2

Participants will receive ACP-196 5 mg (2 x 2.5 mg capsules) orally BID on Day 1.

Group Type: EXPERIMENTAL

ACP-196

Intervention Type: DRUG

Participants will receive ACP-196 oral capsule(s) in all parts.

Part 1 Cohort 3

Participants will receive ACP-196 25 mg capsule orally BID on Day 1.

Group Type: EXPERIMENTAL

ACP-196

Intervention Type: DRUG

Participants will receive ACP-196 oral capsule(s) in all parts.

Part 1 Cohort 4

Participants will receive ACP-196 50 mg (2 x 25 mg capsules) orally BID on Day 1.

Group Type: EXPERIMENTAL

ACP-196

Intervention Type: DRUG

Participants will receive ACP-196 oral capsule(s) in all parts.

Part 1 Cohort 5

Participants will receive ACP-196 100 mg (4 x 25 mg capsules) orally QD on Day 1.

Group Type: EXPERIMENTAL

ACP-196

Intervention Type: DRUG

Participants will receive ACP-196 oral capsule(s) in all parts.

Part 2 Cohort 6

Participants will receive ACP-196 75 mg (3 x 25 mg capsules) orally QD on Day 1 and Day 8.

Group Type: EXPERIMENTAL

ACP-196

Intervention Type: DRUG

Participants will receive ACP-196 oral capsule(s) in all parts.

Part 3 Cohort 7

Participants will receive ACP-196 50 mg (2 x 25 mg capsules) orally QD on Day 1, itraconazole 200 mg capsules BID from Days 4 to 8 with meals and then ACP-196 50 mg (2 x 25 mg capsules) along with itraconazole 200 mg capsule QD on Day 9 under fasting state.

Group Type: EXPERIMENTAL

ACP-196

Intervention Type: DRUG

Participants will receive ACP-196 oral capsule(s) in all parts.

Itraconazole

Intervention Type: DRUG

Participants will receive itraconazole 200 mg capsules BID from Days 4 to 8 with meals and then 200 mg capsule QD on Day 9 under fasting state.

Interventions

ACP-196

Participants will receive ACP-196 oral capsule(s) in all parts.

Intervention Type: DRUG

Itraconazole

Participants will receive itraconazole 200 mg capsules BID from Days 4 to 8 with meals and then 200 mg capsule QD on Day 9 under fasting state.

Intervention Type: DRUG

Other Intervention Names

Acalabrutinib

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Acerta Pharma BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Celerion

Tempe, Arizona, United States

Countries

United States

Other Identifiers

ACE-HV-001

Identifier Type: -

Identifier Source: org_study_id