Healthy VolunteersPhase 1NCT05140096
A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and Its Active Metabolite (ACP-5862) When Administered Alone and With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole in Healthy Adult Participants
A Phase 1 study testing Acalabrutinib, Fluconazole and Isavuconazole in people with Healthy Volunteers, run by Acerta Pharma BV at 1 site in United States.
Trial summary
This study will evaluate the effect of fluconazole and isavuconazole on the PK of acalabrutinib and its active metabolite, ACP-5862. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Acalabrutinib, Fluconazole and Isavuconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2020to 15 Apr 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
- Continuous non-smoker participant who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study
- Have body mass index of >= 18 kg/m^2 and <= 32 kg/m^2 at screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the principal investigator (PI)
- Women participants must be of non-childbearing status and must have undergone the protocol specified sterilization procedures, and have official documentation, at least 6 months prior to the first dose; or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle-stimulating hormone serum levels consistent with postmenopausal status
- Male participants must be willing to use protocol specified contraception methods
- Male participants must agree not to donate sperm from the first dosing until 90 days after the last dosing
- Ability to swallow multiple capsules and/or tablets using size 0 blank capsules (up to a maximum of 3 capsules per participant)
Who cannot join
- 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 or designee
- 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 (including upper respiratory tract infections, but excluding localized cutaneous fungal infections), in the opinion of the PI
- History of any major surgical procedure within 30 days before the first dose of study drug
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing
Show all 24Show fewer
- History or presence of clinically significant hypersensitivity or idiosyncratic reaction to acalabrutinib, fluconazole, isavuconazole, related compounds, or any inactive ingredients
- History or presence of liver disease and diabetes mellitus
- History of stroke or intracranial hemorrhage within 6 months before the first dosing
- History of bleeding diathesis
- Any clinically significant condition that may affect acalabrutinib absorption in the opinion of the PI, including gastric restrictions and bariatric surgery (eg, gastric bypass). Participants with cholecystectomy will be allowed.
- QTcF interval is >460 msec (males) or >470 msec (females) or has ECG findings deemed abnormal with clinical significance by the PI or designee at screening
- Women who are pregnant or lactating
- Positive urine drug or alcohol results at screening or first check-in
- Positive urine cotinine at screening
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs), hepatitis B core antibody (anti-HBc), or hepatitis C virus (HCV)
- Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening
- Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening
- Estimated creatinine clearance <90 mL/min and 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
- Donation of blood or significant blood loss within 56 days and plasma donation within 7 days prior to the first dose of study drug
- Unable to refrain from or anticipates the use of:
- Any drugs, including prescription and nonprescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dose and throughout the study
- Any drugs known to be significant inducers or inhibitor of Cytochrome P450 (CYP) enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, for 28 days prior to the first dose of study drug and throughout the study, including drugs with a narrow therapeutic window that are P-gp substrates such as digoxin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Fixed Sequence Study in Healthy Subjects to Assess the Pharmacokinetics of Acalabrutinib and Its Active Metabolite, ACP-5862, When Administered Alone and in Combination With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole
This study will evaluate the effect of fluconazole and isavuconazole on the PK of acalabrutinib and its active metabolite, ACP-5862.
Read the detailed description
This is a 2-period study. On Day 1 of Period 1, all participants will be randomized to 1 of 2 treatment sequences and will receive a single oral dose of 100 mg acalabrutinib (Treatment A). In Period 2, the participants who participated in Period 1 will receive either Treatment B (fluconazole) or Treatment C (isavuconazole). In Period 2 Treatment B, participants will receive a single oral loading dose of 400 mg fluconazole on Day 1 one hour before a single oral dose of 100 mg acalabrutinib. In Period 2 Treatment C, participants will receive oral dose of 200 mg isavuconazole three times daily (TID; approximately 8 hours apart) on Day 1 and 200 mg isavuconazole once daily (QD) from Day 2 to Day 5 with a single oral dose of 100 mg acalabrutinib coadministered on Day 5. There will be a washout of at least 8 days between Period 1 and first dose in Period 2. All participants will return to the study site approximately 7 days after the last study drug for follow-up procedures and adverse event.
- Conditions
- Healthy Volunteers
- Being tested
- Acalabrutinib, Fluconazole, Isavuconazole
- Keywords
- Healthy participants, Acalabrutinib, ACP-196, Active metabolite, ACP-5862, Fluconazole, Isavuconazole, CYP3A4 Inhibitors, Pharmacokinetics, PK, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcalabrutinibDrug
Modify as "Participants will receive a single oral dose of 100 mg (1 X 100 mg capsule) acalabrutinib either on Day 1 of Period 1 (Treatment A) and Day 1 of Period 2 (Treatment B) or Day 5 of Period 2 (Treatment C).
FluconazoleDrug
Participants will receive 400 mg fluconazole (2 × 200 mg tablets) on Day 1 Period 2 (Treatment B).
IsavuconazoleDrug
Participant will receive oral dose of 200 mg isavuconazole (2 × 186 mg of isavuconazonium sulfate capsules) three times daily on Day 1 and 200 mg isavuconazole (2 × 186 mg of isavuconazonium sulfate capsules) once daily on Days 2 to 5 in Period 2 (Treatment C).
| Study group | Role | What they receive |
|---|---|---|
| Treatment AB | Experimental | Participants will receive a single oral dose 100 mg acalabrutinib capsule on Day 1 of Period 1 (Treatment A) and later will receive single oral loading dose of 400 mg fluconazole tablets on Day 1, one hour prior to a single oral dose of 100 mg acalabrutinib in Period 2 (Treatment B). Receives: Drug: Acalabrutinib; Drug: Fluconazole |
| Treatment AC | Experimental | Participants will receive a single oral dose 100 mg acalabrutinib capsule on Day 1 of Period 1 (Treatment A), and later will receive oral dose of 200 mg iscavuconazole capsules three times daily (approximately every 8 hours apart) on Day 1, followed by 200 mg iscavuconazole capsule once daily from Day 2 to Day 5 with a single oral dose of 100 mg acalabrutinib capsule coadministered on Day 5 in Period 2 (Treatment C). Receives: Drug: Acalabrutinib; Drug: Isavuconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve to the Last Observed Nonzero Concentration (AUC0-t) of Acalabrutinib and ACP-5862
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Area Under the Plasma Concentration-time Curve to Infinity (AUC0-inf) of Acalabrutinib and ACP-5862
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Maximum Observed Plasma Concentration (Cmax) of Acalabrutinib and ACP-5862
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Secondary outcomes (14)
Percent of Area Under the Plasma Concentration-time Curve to Infinity Extrapolated (AUC%extrap) of Acalabrutinib and ACP-5862
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Time of the Maximum Observed Plasma Concentration (Tmax) of Acalabrutinib and ACP-5862
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Time of the Last Measurable Nonzero Plasma Concentration (Tlast) of Acalabrutinib and ACP-5862
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Apparent Terminal Elimination Half-life (T1/2) of Acalabrutinib and ACP-5862
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Apparent Terminal Elimination Rate Constant (Kel) of Acalabrutinib and ACP-5862
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Acalabrutinib
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Apparent Volume of Distribution During the Terminal Elimination Phase After Oral (Extravascular) Administration (Vz/F) of Acalabrutinib
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Metabolite-to-parent Molar Ratio for AUC0-t (MR_AUC0-t) of Acalabrutinib and ACP-5862
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Metabolite-to-parent Molar Ratio for AUC0-inf (MR_AUC0-inf) of Acalabrutinib and ACP-5862
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Metabolite-to-parent Molar Ratio for Cmax (MR_Cmax) of Acalabrutinib and ACP-5862
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Measured: Day 1 through 30 days after the last dose of study drug (approximately 3. 5 months)
Incidences of Abnormal Vital Signs and Physical Examinations Reported as TEAEs
Measured: Day 1 through 30 days after the last dose of study drug (approximately 3. 5 months)
Incidences of Abnormal Electrocardiograms (ECGs) Reported as TEAEs
Measured: Day 1 through 30 days after the last dose of study drug (approximately 3. 5 months)
Incidences of Abnormal Clinical Laboratory Parameters Reported as TEAEs
Measured: Day 1 through 30 days after the last dose of study drug (approximately 3. 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start3 Jan 2020
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Acerta Pharma BVThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerta Pharma BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140096
- Sponsor's protocol ID
- ACE-HV-114
- Status last verified
- Oct 2021
- First submitted
- 17 Nov 2021
- Last updated
- 1 Dec 2021
- 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 request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Fixed Sequence Study in Healthy Subjects to Assess the Pharmacokinetics of Acalabrutinib and Its Active Metabolite, ACP-5862, When Administered Alone and in Combination With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole
- ClinicalTrials.gov ID
- NCT05140096
- Acronym / sponsor ID
- ACE-HV-114
- Conditions
- Healthy Volunteers
- Keywords
- Healthy participants, Acalabrutinib, ACP-196, Active metabolite, ACP-5862, Fluconazole, Isavuconazole, CYP3A4 Inhibitors, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Acerta Pharma BVIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 1 Dec 2021 (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 will evaluate the effect of fluconazole and isavuconazole on the PK of acalabrutinib and its active metabolite, ACP-5862.
Detailed description
This is a 2-period study. On Day 1 of Period 1, all participants will be randomized to 1 of 2 treatment sequences and will receive a single oral dose of 100 mg acalabrutinib (Treatment A). In Period 2, the participants who participated in Period 1 will receive either Treatment B (fluconazole) or Treatment C (isavuconazole). In Period 2 Treatment B, participants will receive a single oral loading dose of 400 mg fluconazole on Day 1 one hour before a single oral dose of 100 mg acalabrutinib. In Period 2 Treatment C, participants will receive oral dose of 200 mg isavuconazole three times daily (TID; approximately 8 hours apart) on Day 1 and 200 mg isavuconazole once daily (QD) from Day 2 to Day 5 with a single oral dose of 100 mg acalabrutinib coadministered on Day 5. There will be a washout of at least 8 days between Period 1 and first dose in Period 2. All participants will return to the study site approximately 7 days after the last study drug for follow-up procedures and adverse event.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment AB | Experimental | Drug: Acalabrutinib, Drug: FluconazoleParticipants will receive a single oral dose 100 mg acalabrutinib capsule on Day 1 of Period 1 (Treatment A) and later will receive single oral loading dose of 400 mg fluconazole tablets on Day 1, one hour prior to a single oral dose of 100 mg acalabrutinib in Period 2 (Treatment B). |
| Treatment AC | Experimental | Drug: Acalabrutinib, Drug: IsavuconazoleParticipants will receive a single oral dose 100 mg acalabrutinib capsule on Day 1 of Period 1 (Treatment A), and later will receive oral dose of 200 mg iscavuconazole capsules three times daily (approximately every 8 hours apart) on Day 1, followed by 200 mg iscavuconazole capsule once daily from Day 2 to Day 5 with a single oral dose of 100 mg acalabrutinib capsule coadministered on Day 5 in Period 2 (Treatment C). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Continuous non-smoker participant who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study
- Have body mass index of >= 18 kg/m^2 and <= 32 kg/m^2 at screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the principal investigator (PI)
- Women participants must be of non-childbearing status and must have undergone the protocol specified sterilization procedures, and have official documentation, at least 6 months prior to the first dose; or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle-stimulating hormone serum levels consistent with postmenopausal status
- Male participants must be willing to use protocol specified contraception methods
Key exclusion criteria (24 listed)
- 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 or designee
- 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 (including upper respiratory tract infections, but excluding localized cutaneous fungal infections), in the opinion of the PI
- History of any major surgical procedure within 30 days before the first dose of study drug
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 |
|---|---|---|
| AcalabrutinibModify as "Participants will receive a single oral dose of 100 mg (1 X 100 mg capsule) acalabrutinib either on Day 1 of Period 1 (Treatment A) and Day 1 of Period 2 (Treatment B) or Day 5 of Period 2 (Treatment C). | Drug | Treatment AB, Treatment AC |
| FluconazoleParticipants will receive 400 mg fluconazole (2 × 200 mg tablets) on Day 1 Period 2 (Treatment B). | Drug | Treatment AB |
| IsavuconazoleParticipant will receive oral dose of 200 mg isavuconazole (2 × 186 mg of isavuconazonium sulfate capsules) three times daily on Day 1 and 200 mg isavuconazole (2 × 186 mg of isavuconazonium sulfate capsules) once daily on Days 2 to 5 in Period 2 (Treatment C). | Drug | Treatment AC |
Primary outcome
Area Under the Plasma Concentration-time Curve to the Last Observed Nonzero Concentration (AUC0-t) of Acalabrutinib and ACP-5862
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Area Under the Plasma Concentration-time Curve to Infinity (AUC0-inf) of Acalabrutinib and ACP-5862
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Maximum Observed Plasma Concentration (Cmax) of Acalabrutinib and ACP-5862
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
14 secondary outcomes
Percent of Area Under the Plasma Concentration-time Curve to Infinity Extrapolated (AUC%extrap) of Acalabrutinib and ACP-5862
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Time of the Maximum Observed Plasma Concentration (Tmax) of Acalabrutinib and ACP-5862
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Time of the Last Measurable Nonzero Plasma Concentration (Tlast) of Acalabrutinib and ACP-5862
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Apparent Terminal Elimination Half-life (T1/2) of Acalabrutinib and ACP-5862
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Apparent Terminal Elimination Rate Constant (Kel) of Acalabrutinib and ACP-5862
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Acalabrutinib
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Apparent Volume of Distribution During the Terminal Elimination Phase After Oral (Extravascular) Administration (Vz/F) of Acalabrutinib
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Metabolite-to-parent Molar Ratio for AUC0-t (MR_AUC0-t) of Acalabrutinib and ACP-5862
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Metabolite-to-parent Molar Ratio for AUC0-inf (MR_AUC0-inf) of Acalabrutinib and ACP-5862
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Metabolite-to-parent Molar Ratio for Cmax (MR_Cmax) of Acalabrutinib and ACP-5862
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 through 30 days after the last dose of study drug (approximately 3. 5 months)
Incidences of Abnormal Vital Signs and Physical Examinations Reported as TEAEs
Time frame: Day 1 through 30 days after the last dose of study drug (approximately 3. 5 months)
Incidences of Abnormal Electrocardiograms (ECGs) Reported as TEAEs
Time frame: Day 1 through 30 days after the last dose of study drug (approximately 3. 5 months)
Incidences of Abnormal Clinical Laboratory Parameters Reported as TEAEs
Time frame: Day 1 through 30 days after the last dose of study drug (approximately 3. 5 months)
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 1 Dec 2021.
- 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 request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Fluconazole and Isavuconazole in people with Healthy Volunteers, run by Acerta Pharma BV 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 1 Dec 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?
Area Under the Plasma Concentration-time Curve to the Last Observed Nonzero Concentration (AUC0-t) of Acalabrutinib and ACP-5862 (time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-acalabrutinib dose in each period (i.e., Days 1 to 2 for Treatments A and B and Days 5 to 6 for Treatment C)). 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 1 Dec 2021.