Infectious DiseasePhase 1NCT04489797
A Study to Evaluate Effects of Proton-pump Inhibitor on Acalabrutinib Capsule When Administered Orally With COCA-COLA in Healthy Participants
A Phase 1 study testing Acalabrutinib and Rabeprazole in people with Infectious Disease, run by AstraZeneca at 1 site in United States.
Trial summary
This study is being conducted to support the clinical development of acalabrutinib in participants who need treatment with proton pump inhibitors while taking acalabrutinib. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease
- What is being tested?
- Acalabrutinib and Rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2020to 28 Aug 2020
- 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
- Capable of giving signed informed consent.
- Male participants and their female partners/spouses must adhere to the contraception methods.
- Female participants must have a negative pregnancy test at screening, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
- Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and follicle stimulating hormone levels in the postmenopausal range.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not bilateral tubal ligation.
- Have a body mass index between 18.5 and 30 kg/m^2, 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 and willing and able to comply with the protocol.
Who cannot join
- History or presence of any clinically significant disease (including active coronavirus disease 2019 infection).
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 30 days of the first administration of investigational medicinal product (IMP).
- Any clinically significant abnormalities in hematology, coagulation, clinical chemistry, or urinalysis results, at screening defined as:
- Hemoglobin less than lower limit of normal.
- Serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase or serum bilirubin (total and direct) > 1.5 upper limit of normal.
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- Any clinically significant abnormal findings in vital signs at screening (eg, systolic blood pressure [BP] < 90 mmHg or ≥ 140 mmHg; diastolic BP < 50 mmHg or ≥ 90 mmHg; pulse < 50 or > 90 bpm).
- Any clinically significant abnormalities on standard 12-lead electrocardiogram at screening.
- Any positive result on screening for serum Hepatitis B surface antigen, hepatitis B, hepatitis C, and Human immunodeficiency virus antibody.
- Has received a new chemical entity 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 visit whichever 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, 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 within the 90 days prior to screening.
- Positive screen for drugs of abuse or cotinine at screening.
- Treatment with a strong cytochrome P450 3A (CYP3A) inhibitor (within 14 days before first administration of IMP) or strong CYP3A inducer (within 28 days before 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 14 days prior to the first administration of IMP or longer if the medication has a long half-life. Hormonal replacement therapy will not be allowed.
- Known or suspected history of alcohol or drug abuse, or excessive intake of alcohol.
- Excessive intake of caffeine-containing drinks or food or would likely be unable to refrain from the use of caffeine-containing beverages during in-house stay at the Clinical Unit.
- Involvement of any AstraZeneca, Acerta Pharma, Parexel or study site employee or their close relatives.
- Judgment by the Investigator that the participant should not participate in the study if they have any ongoing or recent (ie, 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.
- Participants who cannot communicate reliably with the Investigator.
- Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
- Inability to swallow acalabrutinib capsules.
- Evidence of ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections). Note: Participants with localized cutaneous fungal infections are eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Randomized, Single-dose Study of Acalabrutinib in Healthy Subjects to Evaluate the Effect of Proton-pump Inhibitor (Rabeprazole) on Acalabrutinib Capsule When Administered Orally With COCA-COLA
This study is being conducted to support the clinical development of acalabrutinib in participants who need treatment with proton pump inhibitors while taking acalabrutinib.
Read the detailed description
This is an open-label, single-center, randomized study in healthy participants to evaluate the effect of proton-pump inhibitors (rabeprazole; PPI) on acalabrutinib 100-mg capsule dosed orally with COCA-COLA. Participants will receive a single dose of acalabrutinib alone or with rabeprazole, and pharmacokinetic (PK), safety and tolerability will be assessed.
- Conditions
- Infectious Disease
- Being tested
- Acalabrutinib, Rabeprazole
- Keywords
- Pharmacokinetics, Bioavailability
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcalabrutinibDrug
Participants will receive single oral dose of acalabrutinib on day 1 as per the arms they are randomized.
RabeprazoleDrug
Participants will receive twice daily oral dose of 20 mg rabeprazole on days -3, -2, and -1.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Participants will receive single oral dose of acalabrutinib capsule with 100 mL of water. Receives: Drug: Acalabrutinib |
| Arm B | Experimental | Participants will receive single oral dose of acalabrutinib capsule taken with 100 mL of COCA-COLA along with 20 mg rabeprazole. Receives: Drug: Acalabrutinib; Drug: Rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve from time zero to infinity (AUCinf)
Assessment of AUCinf for acalabrutinib and ACP-5862 (metabolite of acalabrutinib) following administration of capsule with and without rabeprazole.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast)
Assessment of AUClast for acalabrutinib and ACP-5862 following administration of capsule with and without rabeprazole.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2
Maximum observed plasma concentration (Cmax)
Assessment of Cmax for acalabrutinib and ACP-5862 following administration of capsule with and without rabeprazole.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2
Secondary outcomes (1)
Number of participants with adverse events and serious adverse events
Assessment of the safety and tolerability of acalabrutinib capsule when administered with COCA-COLA and rabeprazole.
Measured: From screening until Follow-up visit (Upto 5 to 6 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start20 Jul 2020
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Model description
- This is open-label, randomized, single-dose study. The participants will be divided in 2 treatment arms as follows: 1. Arm A (only acalabrutinib) 2. Arm B (acalabrutinib + rabeprazole)
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acerta Pharma BV
- Responsible party
- Sponsor
- Investigators
- Peter J. Winkle, MD FACP FACG CPI, Principal investigator, Anaheim Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489797
- Sponsor's protocol ID
- D822FC00008
- Status last verified
- Oct 2020
- First submitted
- 27 Jul 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Randomized, Single-dose Study of Acalabrutinib in Healthy Subjects to Evaluate the Effect of Proton-pump Inhibitor (Rabeprazole) on Acalabrutinib Capsule When Administered Orally With COCA-COLA
- ClinicalTrials.gov ID
- NCT04489797
- Acronym / sponsor ID
- D822FC00008
- Conditions
- Infectious Disease
- Keywords
- Pharmacokinetics, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Acerta Pharma BV
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to support the clinical development of acalabrutinib in participants who need treatment with proton pump inhibitors while taking acalabrutinib.
Detailed description
This is an open-label, single-center, randomized study in healthy participants to evaluate the effect of proton-pump inhibitors (rabeprazole; PPI) on acalabrutinib 100-mg capsule dosed orally with COCA-COLA. Participants will receive a single dose of acalabrutinib alone or with rabeprazole, and pharmacokinetic (PK), safety and tolerability will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is open-label, randomized, single-dose study. The participants will be divided in 2 treatment arms as follows: 1. Arm A (only acalabrutinib) 2. Arm B (acalabrutinib + rabeprazole)
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: AcalabrutinibParticipants will receive single oral dose of acalabrutinib capsule with 100 mL of water. |
| Arm B | Experimental | Drug: Acalabrutinib, Drug: RabeprazoleParticipants will receive single oral dose of acalabrutinib capsule taken with 100 mL of COCA-COLA along with 20 mg rabeprazole. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Capable of giving signed informed consent.
- Male participants and their female partners/spouses must adhere to the contraception methods.
- Female participants must have a negative pregnancy test at screening, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
- Have a body mass index between 18.5 and 30 kg/m^2, 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 and willing and able to comply with the protocol.
Key exclusion criteria (24 listed)
- History or presence of any clinically significant disease (including active coronavirus disease 2019 infection).
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 30 days of the first administration of investigational medicinal product (IMP).
- Any clinically significant abnormalities in hematology, coagulation, clinical chemistry, or urinalysis results, at screening defined as:
- Any clinically significant abnormal findings in vital signs at screening (eg, systolic blood pressure [BP] < 90 mmHg or ≥ 140 mmHg; diastolic BP < 50 mmHg or ≥ 90 mmHg; pulse < 50 or > 90 bpm).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcalabrutinibParticipants will receive single oral dose of acalabrutinib on day 1 as per the arms they are randomized. | Drug | Arm A, Arm B |
| RabeprazoleParticipants will receive twice daily oral dose of 20 mg rabeprazole on days -3, -2, and -1. | Drug | Arm B |
Primary outcome
Area under plasma concentration-time curve from time zero to infinity (AUCinf)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2
Assessment of AUCinf for acalabrutinib and ACP-5862 (metabolite of acalabrutinib) following administration of capsule with and without rabeprazole.
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2
Assessment of AUClast for acalabrutinib and ACP-5862 following administration of capsule with and without rabeprazole.
Maximum observed plasma concentration (Cmax)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2
Assessment of Cmax for acalabrutinib and ACP-5862 following administration of capsule with and without rabeprazole.
1 secondary outcome
Number of participants with adverse events and serious adverse events
Time frame: From screening until Follow-up visit (Upto 5 to 6 Weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J. Winkle, MD FACP FACG CPI principal investigator
Anaheim Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acalabrutinib and Rabeprazole in people with Infectious Disease, 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 7 inclusion and 24 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 30 Oct 2020. 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?
Area under plasma concentration-time curve from time zero to infinity (AUCinf) (time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on 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?
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 30 Oct 2020.