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AzTrials

BioavailabilityPhase 1NCT04488016

A Study to Evaluate Relative Bioavailability, Proton Pump Inhibitor (PPI) (Rabeprazole) Effect, Food Effect and Particle Size Effect of New Acalabrutinib Tablet in Healthy Subjects

A Phase 1 study testing Treatment A- Part 1, Treatment B- Part 1 and Treatment C - Part 1 in people with Bioavailability and B-cell Lymphoid Cancer, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be a 2-part, open-label, single-center relative bioavailability, PPI effect, food-effect and particle size effect randomized crossover study of acalabrutinib tablets in healthy subjects (males or females). Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Bioavailability, B-cell Lymphoid Cancer
What is being tested?
Treatment A- Part 1, Treatment B- Part 1 and Treatment C - Part 1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
24 Jun 2020to 20 Jan 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Provision of signed and dated, written informed consent prior to any study specific procedures.
  • Healthy adult male or female subjects aged 18 - 55 years with suitable veins for cannulation or repeated venipuncture.
  • Male subject must adhere to the contraception methods.
  • Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening.
  • Have a Body mass index (BMI) between 18.5 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive at screening.
  • Understands the study procedures in the Informed Consent Form (ICF) and willing and able to comply with the protocol.
  • Willingness and ability to swallow study drugs, including the SmartPill.
  • Willingness to consume a standardized, high- calorie, high-fat FDA breakfast.

Who cannot join

  • History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator (PI), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
  • History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • Evidence of ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections).
  • Any clinically significant illness, medical/surgical procedure, or trauma within 30 days of the first administration of IMP.
  • Any clinically significant abnormalities in clinical chemistry, hematology, coagulation, or urinalysis results, at screening and first admission to the study unit (first treatment period) as judged by the PI, and defined as: (1) Serum Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase (ALP), and serum bilirubin (total and direct)
  • > Upper limit of normal (ULN). (2) Hemoglobin < ULN.
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  • Any clinically significant abnormal findings in vital signs at screening and first admission to the study unit (first treatment period), as judged by the PI.
  • Any clinically significant abnormalities on 12-lead ECG at screening and first admission to the study unit (first treatment period), as judged by the PI.
  • Any positive result on screening for serum hepatitis B surface antigen, hepatitis B core antibody (anti-HBc), hepatitis C antibody, and HIV antibody.
  • Known or suspected history of drug abuse, as judged by the PI.
  • Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 90 days of the first administration of IMP in this study.
  • The period of exclusion begins 90 days after the final dose or 30 days after the last visitwhichever is the longest.
  • Plasma donation within 30 days of screening or any blood donation/loss more than 500 mL during the 90 days prior to screening.
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to acalabrutinib or rabeprazole.
  • Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 90 days prior to screening.
  • Positive screen for drugs of abuse or cotinine at screening or on each admission to the study center or positive screen for alcohol on each admission to the study center.
  • Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
  • Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life. Hormone replacement therapy will not be allowed.
  • Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the PI.
  • Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by the PI. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day (e.g., >5 cups of coffee) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the investigational site.
  • Part 1 only: Inability or unwillingness to swallow SmartPill, including:
  • Subject has any of the following contraindications for the SmartPill:
  • A history of gastric bezoars
  • Swallowing disorders
  • Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
  • History of GI surgery within 90 days of administration
  • Severe dysphagia to food or pills
  • Crohn's disease or diverticulitis
  • Cardiac pacemakers or other implanted electromedical devices 20 Involvement of any AstraZeneca, Acerta Pharma, Parexel or study site employee or their close relatives. 21 Subjects who have previously received acalabrutinib. 22 Judgment by the PI that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements. 23 Subjects who cannot communicate reliably with the Investigator. 24 Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Research Site

    Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A 2-Part, Phase I, Open-label, Single-Dose, Sequential Randomized Crossover Study of New Acalabrutinib Tablet in Healthy Subjects to Evaluate Relative Bioavailability, Proton Pump Inhibitor (Rabeprazole) Effect, Food Effect and Particle Size Effect

This study will be a 2-part, open-label, single-center relative bioavailability, PPI effect, food-effect and particle size effect randomized crossover study of acalabrutinib tablets in healthy subjects (males or females). The study will be divided in 2 study parts; following a review of the safety and Pharmacokinetics (PK) data from Part 1, the study is planned to be continued with Part 2.

Read the detailed description

The study will be divided in 2 study parts; Part 1 of this study will be an open-label, 3-treatment-period, 4-treatment, single-center relative bioavailability, PPI effect, and food-effect randomized crossover study of a new acalabrutinib tablet in healthy subjects (males or females).

The relative bioavailability part of Study Part 1 is designed to investigate the PK of the acalabrutinib tablet compared with the PK of acalabrutinib capsule, when administered as a single dose with water under the fasted condition (>10 hours). The PPI effect part of Study Part 1 is designed to compare the PK of acalabrutinib tablet with or without coadministration of the PPI rabeprazole. The food-effect part of Study Part 1 is designed to compare the PK of acalabrutinib tablet under fed and fasted conditions. For each subject, a SmartPill will be administered with 120 mL of still water followed immediately by a single oral dose of acalabrutinib tablet (Treatment B, C or D) or acalabrutinib capsule (Treatment A) administered with 120 mL of still water.

Study Part 1 will comprise:

  • A screening period of maximum 28 days;
  • Three treatment periods during which subjects will be resident from prior to the evening meal the night before dosing with Investigational medicinal product (IMP) (Day -1) until at least 48 hours after dosing; discharged on the morning of Day 3; and
  • A Follow-up Visit within 7 to 10 days. There will be a minimum washout period of at least 7 days between each acalabrutinib administration.

A decision to continue with Study Part 2 will be made following a review of the preliminary data for relative bioavailability (acalabrutinib tablet versus acalabrutinib capsule), food effect, PPI effect, and safety observed in Part 1.

Part 2 of this study will be an open-label, 4-treatment-period, 4-treatment, single-center relative bioavailability, randomized crossover study to determine the effect of particle size on the PK of a single dose of acalabrutinib tablet in healthy subjects (males or females).

This relative bioavailability study is designed to investigate the PK of acalabrutinib tablets with various drug substance particle size distributions and the PK of acalabrutinib solution at a single oral dose of 100 mg under the fasted condition (>10 hours).

Study Part 2 will comprise:

  • A screening period of maximum 28 days;
  • Four treatment periods during which subjects will be resident prior to the evening meal the night before dosing with IMP (Day -1) until at least 48 hours after dosing; discharged on the morning of Day 3; and
  • A Follow-up Visit within 7 to 10 days. There will be a minimum washout period of at least 3 days between each acalabrutinib administration.
Being tested
Treatment A- Part 1, Treatment B- Part 1, Treatment C - Part 1, Treatment D- Part 1, Treatment A-Part 2
Keywords
Bruton tyrosine kinase (BTK) inhibitor, Proton Pump Inhibitor (Rabeprazole) Effect, Food Effect, Particle Size Effect

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment A- Part 1Drug

    Subjects will receive 100 mg acalabrutinib capsule, fasted state;

  • Treatment B- Part 1Drug

    Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fasted state

  • Treatment C - Part 1Drug

    Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fed state

  • Treatment D- Part 1Drug

    Subjects will receive Rabeprazole 20 mg QD (fasted) at 2 hours before administration of 100 mg acalabrutinib tablet (Variant 1) and following prior administration of rabeprazole 20 mg Twice per day (BID) (with meals) on Days -3, -2 and -1.

  • Treatment A-Part 2Drug

    Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fasted state

  • Treatment B - Part 2Drug

    Subjects will receive 100 mg acalabrutinib tablet (Variant 2), fasted state

  • Treatment C - Part 2Drug

    Subjects will receive 100 mg acalabrutinib tablet (Variant 3), fasted state

  • Treatment D - Part 2Drug

    Subjects will receive 100 mg acalabrutinib solution, (Variant 4), fasted state

Study groups in NCT04488016
Study groupRoleWhat they receive
Cohort 1 -Part 1ExperimentalSubjects will be randomized to one of 4 sequences ABC, BAC, ABD, or BAD. Subjects will receive 100 mg acalabrutinib capsule, fasted state (>10 h) in Treatment A , 100 mg acalabrutinib tablet (Variant 1), fasted state (>10 h) in Treatment B, 100 mg acalabrutinib tablet (Variant 1), fed state in Treatment C, Rabeprazole 20 mg ×1 (fasted) at 2 hours before administration of 100 mg acalabrutinib tablet (Variant 1)* and following prior administration of rabeprazole 20 mg BID (with meals) on Days -3, -2 and -1 in Treatment D.
Receives: Drug: Treatment A- Part 1; Drug: Treatment B- Part 1; Drug: Treatment C - Part 1
Cohort 2- Part 1ExperimentalSubjects will be randomized to one of 4 sequences ABC, BAC, ABD, or BAD. Subjects will receive 100 mg acalabrutinib capsule, fasted state (>10 h) in Treatment A , 100 mg acalabrutinib tablet (Variant 1), fasted state (>10 h) in Treatment B, 100 mg acalabrutinib tablet (Variant 1), fed state in Treatment C, Rabeprazole 20 mg ×1 (fasted) at 2 hours before administration of 100 mg acalabrutinib tablet (Variant 1)* and following prior administration of rabeprazole 20 mg BID (with meals) on Days -3, -2 and -1 in Treatment D.
Receives: Drug: Treatment A- Part 1; Drug: Treatment B- Part 1; Drug: Treatment C - Part 1
Cohort 3- Part 1ExperimentalSubjects will be randomized to one of 4 sequences ABC, BAC, ABD, or BAD. Subjects will receive 100 mg acalabrutinib capsule, fasted state (>10 h) in Treatment A , 100 mg acalabrutinib tablet (Variant 1), fasted state (>10 h) in Treatment B, 100 mg acalabrutinib tablet (Variant 1), fed state in Treatment C, Rabeprazole 20 mg ×1 (fasted) at 2 hours before administration of 100 mg acalabrutinib tablet (Variant 1)* and following prior administration of rabeprazole 20 mg BID (with meals) on Days -3, -2 and -1 in Treatment D.
Receives: Drug: Treatment A- Part 1; Drug: Treatment B- Part 1; Drug: Treatment C - Part 1; Drug: Treatment D- Part 1
Cohort 4 - Part 1ExperimentalSubjects will be randomized to one of 4 sequences: ABC, BAC, ABD, or BAD. Subjects will receive 100 mg acalabrutinib capsule, fasted state (>10 h) in Treatment A , 100 mg acalabrutinib tablet (Variant 1), fasted state (>10 h) in Treatment B, 100 mg acalabrutinib tablet (Variant 1), fed state in Treatment C, Rabeprazole 20 mg ×1 (fasted) at 2 hours before administration of 100 mg acalabrutinib tablet (Variant 1)* and following prior administration of rabeprazole 20 mg BID (with meals) on Days -3, -2 and -1 in Treatment D.
Receives: Drug: Treatment A- Part 1; Drug: Treatment B- Part 1; Drug: Treatment C - Part 1; Drug: Treatment D- Part 1
Cohort 1- Part 2ExperimentalSubjects will be randomized to one of 2 sequences in a 2×4 crossover: ABCD or BADC. In Part 2, subjects will be receiving 100 mg acalabrutinib tablet (Variant 1), Variant 2, Variant 3, and 100 mg acalabrutinib solution.
Receives: Drug: Treatment A-Part 2; Drug: Treatment B - Part 2; Drug: Treatment C - Part 2; Drug: Treatment D - Part 2
Cohort 2 - Part 2ExperimentalSubjects will be randomized to one of 2 sequences in a 2×4 crossover: ABCD or BADC.In Part 2, subjects will be receiving 100 mg acalabrutinib tablet (Variant 1), Variant 2, Variant 3, and 100 mg acalabrutinib solution.
Receives: Drug: Treatment A-Part 2; Drug: Treatment B - Part 2; Drug: Treatment C - Part 2; Drug: Treatment D - Part 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed plasma concentration (Cmax)-Acalabrutinib

    Part 1: To assess the relative bioavailability of the acalabrutinib tablet compared with acalabrutinib capsules in fasted state.

    Part 2: To assess the impact of drug substance particle size on the bioavailability of acalabrutinib tablets.

    Measured: Day 1 and Day 2

  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast)-Acalabrutinib

    Part 1: To assess the relative bioavailability of the acalabrutinib tablet compared with acalabrutinib capsules in fasted state.

    Part 2: To assess the impact of drug substance particle size on the bioavailability of acalabrutinib tablets.

    Measured: Day 1 and Day 2

  3. Area under plasma concentration-time curve from time zero to infinity (AUCinf)-Acalabrutinib

    Part 1: To assess the relative bioavailability of the acalabrutinib tablet compared with acalabrutinib capsules in fasted state.

    Part 2: To assess the impact of drug substance particle size on the bioavailability of acalabrutinib tablets.

    Measured: Day 1 and Day 2

Secondary outcomes (52)

  1. Cmax -ACP-5862

    Part 1: To assess the ACP-5862 PK profile of the acalabrutinib tablet compared with acalabrutinib capsule in fasted state.

    Part 2: To assess the impact of drug substance particle size on the ACP-5862 PK profile of acalabrutinib tablets.

    Measured: Day 1 and Day 2

  2. AUClast-ACP-5862

    Part 1: To assess the ACP-5862 PK profile of the acalabrutinib tablet compared with acalabrutinib capsule in fasted state.

    Part 2: To assess the impact of drug substance particle size on the ACP-5862 PK profile of acalabrutinib tablets.

    Measured: Day 1 and Day 2

  3. AUCinf-ACP-5862

    Part 1: To assess the ACP-5862 PK profile of the acalabrutinib tablet compared with acalabrutinib capsule in fasted state.

    Part 2: To assess the impact of drug substance particle size on the ACP-5862 PK profile of acalabrutinib tablets.

    Measured: Day 1 and Day 2

  4. Area under the plasma concentration-time curve from time zero to 12 hours post-dose (AUC0-12) - Acalabrutinib and ACP-5862

    Part 1: To evaluate the effects of proton pump inhibitor rabeprazole on acalabrutinib and its metabolite (ACP-5862) PK profiles obtained after dosing the acalabrutinib tablet; To evaluate the effect of food on acalabrutinib and its metabolite (ACP-5862) PK obtained after dosing the acalabrutinib tablet.

    Part 2: To compare PK of acalabrutinib tablet versus acalabrutinib oral solution in healthy subjects.

    Measured: Day 1 and Day 2

  5. AUClast- Acalabrutinib and ACP-5862

    Part 1: To evaluate the effects of proton pump inhibitor rabeprazole on acalabrutinib and its metabolite (ACP-5862) PK profiles obtained after dosing the acalabrutinib tablet; To evaluate the effect of food on acalabrutinib and its metabolite (ACP-5862) PK obtained after dosing the acalabrutinib tablet.

    Part 2: To compare PK of acalabrutinib tablet versus acalabrutinib oral solution in healthy subjects.

    Measured: Day 1 and Day 2

  6. AUCinf- Acalabrutinib and ACP-5862

    Part 1: To evaluate the effects of proton pump inhibitor rabeprazole on acalabrutinib and its metabolite (ACP-5862) PK profiles obtained after dosing the acalabrutinib tablet; To evaluate the effect of food on acalabrutinib and its metabolite (ACP-5862) PK obtained after dosing the acalabrutinib tablet.

    Part 2: To compare PK of acalabrutinib tablet versus acalabrutinib oral solution in healthy subjects.

    Measured: Day 1 and Day 2

  7. Extrapolated area under the curve from tlast to infinity, expressed as percentage of AUCinf (%AUCextrap)- Acalabrutinib and ACP-5862

    Part 1: To evaluate the effects of proton pump inhibitor rabeprazole on acalabrutinib and its metabolite (ACP-5862) PK profiles obtained after dosing the acalabrutinib tablet; To evaluate the effect of food on acalabrutinib and its metabolite (ACP-5862) PK obtained after dosing the acalabrutinib tablet.

    Part 2: To compare PK of acalabrutinib tablet versus acalabrutinib oral solution in healthy subjects.

    Measured: Day 1 and Day 2

  8. Cmax- Acalabrutinib and ACP-5862

    Part 1: To evaluate the effects of proton pump inhibitor rabeprazole on acalabrutinib and its metabolite (ACP-5862) PK profiles obtained after dosing the acalabrutinib tablet; To evaluate the effect of food on acalabrutinib and its metabolite (ACP-5862) PK obtained after dosing the acalabrutinib tablet.

    Part 2: To compare PK of acalabrutinib tablet versus acalabrutinib oral solution in healthy subjects.

    Measured: Day 1 and Day 2

  9. Half-life associated with terminal slope of a semi-logarithmic concentration-time Curve (t½)- Acalabrutinib and ACP-5862

    Part 1: To evaluate the effects of proton pump inhibitor rabeprazole on acalabrutinib and its metabolite (ACP-5862) PK profiles obtained after dosing the acalabrutinib tablet; To evaluate the effect of food on acalabrutinib and its metabolite (ACP-5862) PK obtained after dosing the acalabrutinib tablet.

    Part 2: To compare PK of acalabrutinib tablet versus acalabrutinib oral solution in healthy subjects.

    Measured: Day 1 and Day 2

  10. Time to reach maximum observed concentration (tmax)- Acalabrutinib and ACP-5862

    Part 1: To evaluate the effects of proton pump inhibitor rabeprazole on acalabrutinib and its metabolite (ACP-5862) PK profiles obtained after dosing the acalabrutinib tablet; To evaluate the effect of food on acalabrutinib and its metabolite (ACP-5862) PK obtained after dosing the acalabrutinib tablet.

    Part 2: To compare PK of acalabrutinib tablet versus acalabrutinib oral solution in healthy subjects.

    Measured: Day 1 and Day 2

  11. Terminal elimination rate constant (Kel)- Acalabrutinib and ACP-5862

    Part 1: To evaluate the effects of proton pump inhibitor rabeprazole on acalabrutinib and its metabolite (ACP-5862) PK profiles obtained after dosing the acalabrutinib tablet; To evaluate the effect of food on acalabrutinib and its metabolite (ACP-5862) PK obtained after dosing the acalabrutinib tablet.

    Part 2: To compare PK of acalabrutinib tablet versus acalabrutinib oral solution in healthy subjects.

    Measured: Day 1 and Day 2

  12. Relative bioavailability (Frel)- Acalabrutinib and ACP-5862

    Part 1: To evaluate the effects of proton pump inhibitor rabeprazole on acalabrutinib and its metabolite (ACP-5862) PK profiles obtained after dosing the acalabrutinib tablet; To evaluate the effect of food on acalabrutinib and its metabolite (ACP-5862) PK obtained after dosing the acalabrutinib tablet.

    Part 2: To compare PK of acalabrutinib tablet versus acalabrutinib oral solution in healthy subjects.

    Measured: Day 1 and Day 2

  13. Apparent total body clearance of drug from plasma after extravascular administration (CL/F)- Acalabrutinib and ACP-5862

    Part 1: To evaluate the effects of proton pump inhibitor rabeprazole on acalabrutinib and its metabolite (ACP-5862) PK profiles obtained after dosing the acalabrutinib tablet; To evaluate the effect of food on acalabrutinib and its metabolite (ACP-5862) PK obtained after dosing the acalabrutinib tablet.

    Part 2: To compare PK of acalabrutinib tablet versus acalabrutinib oral solution in healthy subjects.

    Measured: Day 1 and Day 2

  14. Apparent volume of distribution during the terminal phase after extravascular Administration (Vz/F)- Acalabrutinib and ACP-5862

    Part 1: To evaluate the effects of proton pump inhibitor rabeprazole on acalabrutinib and its metabolite (ACP-5862) PK profiles obtained after dosing the acalabrutinib tablet; To evaluate the effect of food on acalabrutinib and its metabolite (ACP-5862) PK obtained after dosing the acalabrutinib tablet.

    Part 2: To compare PK of acalabrutinib tablet versus acalabrutinib oral solution in healthy subjects.

    Measured: Day 1 and Day 2

  15. ACP-5862 (metabolite) to acalabrutinib (parent) ratio (M/P) for Cmax- Acalabrutinib and ACP-5862

    Part 1: To evaluate the effects of proton pump inhibitor rabeprazole on acalabrutinib and its metabolite (ACP-5862) PK profiles obtained after dosing the acalabrutinib tablet; To evaluate the effect of food on acalabrutinib and its metabolite (ACP-5862) PK obtained after dosing the acalabrutinib tablet.

    Part 2: To compare PK of acalabrutinib tablet versus acalabrutinib oral solution in healthy subjects.

    Measured: Day 1 and Day 2

  16. ACP-5862 (metabolite) to acalabrutinib (parent) ratio (M/P) for AUClast- Acalabrutinib and ACP-5862

    Part 1: To evaluate the effects of proton pump inhibitor rabeprazole on acalabrutinib and its metabolite (ACP-5862) PK profiles obtained after dosing the acalabrutinib tablet; To evaluate the effect of food on acalabrutinib and its metabolite (ACP-5862) PK obtained after dosing the acalabrutinib tablet.

    Part 2: To compare PK of acalabrutinib tablet versus acalabrutinib oral solution in healthy subjects.

    Measured: Day 1 and Day 2

  17. ACP-5862 (metabolite) to acalabrutinib (parent) ratio (M/P) for AUCinf- Acalabrutinib and ACP-5862

    Part 1: To evaluate the effects of proton pump inhibitor rabeprazole on acalabrutinib and its metabolite (ACP-5862) PK profiles obtained after dosing the acalabrutinib tablet; To evaluate the effect of food on acalabrutinib and its metabolite (ACP-5862) PK obtained after dosing the acalabrutinib tablet.

    Part 2: To compare PK of acalabrutinib tablet versus acalabrutinib oral solution in healthy subjects.

    Measured: Day 1 and Day 2

  18. Number of subjects with adverse events

    Number of subjects reporting at least one event and number of events where appropriate

    Measured: From Screening to follow-up visit (7 to 10 days after last dose)

  19. Number of subjects with abnormal systolic and diastolic blood pressure

    Abnormal values in systolic and diastolic blood pressure.

    Measured: At screening (Day -28), Day -1, and Day 2

  20. Number of subjects with abnormal pulse rate

    Abnormal values in pulse rate.

    Measured: At screening (Day -28), Day -1, and Day 2

  21. Number of subjects with abnormal respiratory rate

    Abnormal values in respiratory rate.

    Measured: At screening (Day -28), Day -1, and Day 2

  22. Number of subjects with abnormal body temperature

    Abnormal values of body temperature.

    Measured: At screening (Day -28), Day -1, and Day 2

  23. Number of subjects with abnormal electrocardiogram (12-lead ECG)

    Prolongation of the QTc interval.

    Measured: At screening (Day -28), Day -1, and Day 2

  24. Number of subjects with abnormal physical examination

    Abnormal values in physical examination

    Measured: At screening (Day -28), Day -1, and Day 2

  25. Number of subjects with abnormal hematology -Cell count

    To assess white blood cell count and red blood cell count.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  26. Number of subjects with abnormal electrolytes

    To assess abnormal serum level of sodium and potassium.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  27. Number of subjects with abnormal hemoglobin (Hb)

    Abnormal values of hemoglobin

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  28. Number of subjects with abnormal hematocrit

    Abnormal values of hematocrit.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  29. Number of subjects with abnormal mean corpuscular volume (MCV)

    Abnormal values of MCV

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  30. Number of subjects with abnormal mean corpuscular hemoglobin (MCH)

    Abnormal values of MCH

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  31. Number of subjects with abnormal mean corpuscular hemoglobin concentration (MCHC)

    Abnormal values of MCHC

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  32. Number of subjects with abnormal clinical chemistry

    The laboratory variables to be measured are: bilirubin.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  33. Incidence of abnormal urinalysis

    The laboratory variables to be measured are: protein in urine. Microscopy (if positive for protein): Casts (Cellular, Granular, Hyaline).

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  34. Number of subjects with abnormal glucose (fasting)

    Abnormal values of glucose (fasting)

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  35. Number of subjects with abnormal C-reactive protein (CRP)

    Abnormal values of CRP.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  36. Number of subjects with abnormal blood urea nitrogen (BUN)

    Abnormal values of BUN

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  37. Number of subjects with abnormal thyroid-stimulating hormone (TSH)

    Abnormal values of TSH

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  38. Number of subjects with abnormal T4

    Abnormal values of T4

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  39. Number of subjects with abnormal hematology- Differential count

    To assess neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, basophils absolute count, platelets, and reticulocytes absolute count.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  40. Percentage of subjects with adverse events

    Percentage of subjects reporting at least one event and number of events where appropriate

    Measured: From Screening to follow-up visit (7 to 10 days after last dose)

  41. Number of subjects with abnormal electrolytes

    To assess abnormal serum level of calcium.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  42. Number of subjects with abnormal electrolytes

    To assess abnormal serum level of phosphate.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  43. Number of subjects with abnormal clinical chemistry

    The laboratory variables to be measured are: alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST).

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  44. Number of subjects with abnormal clinical chemistry

    The laboratory variables to be measured are: creatinine.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  45. Number of subjects with abnormal clinical chemistry

    The laboratory variables to be measured are: albumin.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  46. Number of subjects with abnormal clinical chemistry

    The laboratory variables to be measured are: cystatin C.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  47. Number of subjects with abnormal clinical chemistry

    The laboratory variables to be measured are: gamma glutamyl transpeptidase.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  48. Number of subjects with abnormal clinical chemistry

    The laboratory variables to be measured are: urea and uric acid.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  49. Incidence of abnormal urinalysis

    The laboratory variables to be measured are: glucose in urine.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  50. Incidence of abnormal urinalysis

    The laboratory variables to be measured are: blood in urine. Microscopy (if positive blood): RBC, WBC.

    Measured: At screening (Day -28), Day-1, Day 1, Day 2, and Follow-up visit (7-10 days after last dose)

  51. Taste

    The taste of the acalabrutinib oral solution (Treatment D) will be assessed by a taste and smell questionnaire after the administration of the IMP. Subjects will be asked to complete the questionnaire themselves which will rate questions on the taste of the IMP (sweet, salty, sour, bitter, metallic, hot/spicy, overall taste of the medicine) from 0 to 10 (where 0 is extremely bad and 10 is extremely nice).

    Measured: Day 1

  52. Smell

    The smell of the acalabrutinib oral solution (Treatment D) will be assessed by a taste and smell questionnaire after the administration of the IMP. Subjects will be asked to complete the questionnaire themselves which will rate questions on the smell of the IMP (extremely bad to extremely nice, whether subjects would take it again) of the medicine) from 0 to 10 (where 0 is extremely bad and 10 is extremely nice).

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2020
  2. Study start24 Jun 2020
  3. Primary completion20 Jan 2021
  4. Study completion20 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04488016
Sponsor's protocol ID
D8220C00018
Status last verified
Feb 2021
First submitted
23 Jun 2020
Last updated
3 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treatment A- Part 1, Treatment B- Part 1 and Treatment C - Part 1 in people with Bioavailability and B-cell Lymphoid Cancer, run by AstraZeneca at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum observed plasma concentration (Cmax)-Acalabrutinib (time frame: Day 1 and Day 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04488016.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.

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