A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196

NCT04914936 | Completed Phase 1 FDA Drug

• 1 other identifier: ACE-HV-004
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate one-way interaction of calcium carbonate, omeprazole, or rifampin on ACP-196.

Conditions

Healthy Participants

Keywords

Acalabrutinib; ACP-196; Healthy participants; Pharmacokinetics; PK; Safety

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of ACP-196 in Parts 1, 2, and 3

  Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3

• Maximum Observed Plasma Concentration (Cmax) of ACP-196 in Parts 1, 2, and 3

  Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3

Secondary Outcomes (11)

• Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-last) of ACP-196 in Parts 1, 2, and 3

  Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3

• Percent of AUC0inf Extrapolated (AUC%extrap) of ACP-196 in Parts 1, 2, and 3

  Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3

• Area Under the Plasma Concentration-time Curve From Time 0 to 24 hours (AUC0-24h) of ACP-196 in Parts 1, 2, and 3

  Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of ACP-196 in Parts 1, 2, and 3

  Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3

• Apparent Terminal Elimination Half-life (T1/2) of ACP-196 in Parts 1, 2, and 3

  Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3

Study Arms (3)

Part 1: ACP-196 and Calcium carbonate

EXPERIMENTAL

Participants will receive a single oral dose of ACP-196 100 mg capsule on Day 1 of Period 1 and a single oral dose of calcium carbonate 1 g tablet coadministered with a single oral dose of ACP-196 100 mg capsule on Day 1 of Period 2.

Drug: ACP-196; Drug: Calcium carbonate

Part 2: ACP-196 and Omeprazole

EXPERIMENTAL

Participants will receive a single oral dose of ACP-196 100 mg capsule on Day 1 of Period 1 and oral dose of omeprazole 40 mg capsules once daily (QD) for 5 consecutive days coadministered with a single oral dose of ACP-196 100 mg capsule on Day 5 of Period 2.

Drug: ACP-196; Drug: Omeprazole

Part 3: ACP-196 and Rifampin

EXPERIMENTAL

Participants will receive a single oral dose of ACP-196 100 mg capsule on Day 1 of Period 1 and oral dose of rifampin 600 mg capsule QD for 9 consecutive days coadministered with a single oral dose of ACP-196 100 mg capsule on Day 1 and Day 9 of Period 2.

Drug: ACP-196; Drug: Rifampin

Interventions

ACP-196 DRUG

Participants will receive a single oral dose of ACP-196 100 mg capsule on Day 1 of Period 1 in Part 1, Part 2, and Part 3; and on Day 1 of Period 2 in Part 1, Day 5 of Period 2 in Part 2, and Day 1 and Day 9 of Period 2 in Part 3.

Also known as: Acalabrutinib

Part 1: ACP-196 and Calcium carbonate; Part 2: ACP-196 and Omeprazole; Part 3: ACP-196 and Rifampin

Calcium carbonate DRUG

Participants will receive a single oral dose of calcium carbonate 1 g tablet on Day 1 of Period 2 in Part 1.

Part 1: ACP-196 and Calcium carbonate

Omeprazole DRUG

Participants will receive multiple oral doses of omeprazole 40 mg capsules QD for 5 consecutive days in Period 2 of Part 2.

Part 2: ACP-196 and Omeprazole

Rifampin DRUG

Participants will receive multiple oral doses of rifampin 600 mg capsule QD for 9 consecutive days in Period 2 of Part 3.

Part 3: ACP-196 and Rifampin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to 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 (ECGs), as deemed by the principal investigator (PI). Liver function tests must be =\< upper limit of normal range (ULN).
• Women must be of non-childbearing status and must have negative serum pregnancy test results.
• Men of reproductive potential to follow protocol defined contraception methods.
• Able to swallow multiple capsules.

You may not qualify if:

• 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 or presence of clinically significant medical or psychiatric condition or disease 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 participant 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 prior to screening.
• Women who are pregnant or lactating.
• 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 less than 90/40 mm Hg or greater than 140/90 mmHg at screening.
• Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.
• Hemoglobin level below the lower limit of normal at screening.
• Have been on a diet incompatible with the on-study diet, in the opinion of the PI, within the 28 days prior to the first dose of study drug, and throughout the study.
• Unable to refrain from or anticipates the use of any protocol defined drugs.
• Donation of blood or significant blood loss within 56 days prior to the first dose of study drug.

Sponsors & Collaborators

• Acerta Pharma BV: lead

Study Sites (1)

Unknown Facility

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

acalabrutinib; Calcium Carbonate; Omeprazole; Rifampin

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Ahmed Hamdy, MD

  Acerta Pharma BV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 7, 2021
• Study Start: September 21, 2014
• Primary Completion: October 16, 2014
• Study Completion: October 16, 2014
• Last Updated: June 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

US (1)