Healthy VolunteersPhase 1NCT04876807
A Study to Evaluate the Effect of an Acidic Formulation of Acalabrutinib (ACP-196), Acidic Beverage, or Grapefruit Juice on the Pharmacokinetics (PK) of ACP-196 Alone and Coadministered With Omeprazole
A Phase 1 study testing ACP-196 and Omeprazole 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 an acidic formulation of Acalabrutinib (ACP-196), acidic beverage, or grapefruit Juice on the PK of ACP-196 alone and coadministered with omeprazole. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ACP-196 and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2016to 15 Mar 2016
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Continuous non-smoker who has not used nicotine-containing products for ≥ 3 months before 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, as deemed by the principal investigator (PI). Liver function tests must be =< the upper limit of normal range (ULN) at screening for inclusion.
- Men and women of reproductive potential to follow protocol defined contraception methods.
- Women must have negative serum pregnancy test results.
- Willing and able to take the study drug with 240 mL of orange drink (Part 2) or grapefruit juice (Part 3).
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.
- Participant with known fruit allergies.
- History or presence of clinically significant medical or psychiatric condition or disease (eg, cardiovascular, respiratory, hepatic, gastrointestinal, renal, genitourinary, endocrine, neuromuscular, rheumatologic, oncologic, cutaneous or other disorders), 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 subject 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 before screening.
Show all 22Show fewer
- History of bleeding diathesis (eg, hemophilia, von Willebrand disease).
- Any clinically significant condition that may affect acalabrutinib absorption in the opinion of the PI, including gastric restrictions and bariatric surgery (eg, gastric bypass).
- History or presence of clinically significant thyroid disease, in the opinion of the PI.
- Women who are pregnant or breastfeeding.
- 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 < 90/40 mm Hg or > 140/90 mm Hg at screening.
- Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.
- Have been on a diet incompatible with the on study diet, in the opinion of the PI, within the 28 days before the first dose of study drug, and throughout the study.
- Unable to refrain from or anticipates the use of protocol defined medicines:
- Donation of blood or significant blood loss within 56 days before the first dose of study drug.
- Plasma donation within 7 days before the first dose of study drug.
- Prior exposure to acalabrutinib (ACP-196).
- History or presence of clinically significant hypersensitivity or idiosyncratic reaction to acalabrutinib, omeprazole, related compounds (eg, substituted benzimidazoles, other azole compounds), or any inactive ingredients.
- History or presence of liver disease and Clostridium difficile-associated diarrhea.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laura Sterling, MD, MPH
Lincoln, Nebraska, (402) 437-483
About this study
Official title: A Phase 1, Single-center, Open-label, Fixed-sequence, 4-period, 3-part Study in Healthy Adult Subjects to Evaluate the Effect of an Acidic Formulation of Acalabrutinib (ACP-196), Acidic Beverage, or Grapefruit Juice on the Pharmacokinetics of Acalabrutinib Alone and Coadministered With Omeprazole
This study will evaluate the effect of an acidic formulation of Acalabrutinib (ACP-196), acidic beverage, or grapefruit Juice on the PK of ACP-196 alone and coadministered with omeprazole.
Read the detailed description
This is a 3-part study. Each part of the study will compare the effect of an acidic formulation of ACP-196, acidic beverage (orange drink), or grapefruit juice on the PK profile of ACP-196 alone and when coadministered with omeprazole. Participants will be enrolled into Part 1 of the study first and then subsequent participants will be randomized in a 1:1 ratio to either Part 2 or Part 3 of the study. Participants will be screened within 28 days before the dose. Participants will be contacted approximately 14 days after the last dose of study drug administration to determine if any adverse event has occurred since the last dose of study drug.
- Conditions
- Healthy Volunteers
- Being tested
- ACP-196, Omeprazole
- Keywords
- Acalabrutinib, ACP-196, Healthy volunteers, Pharmacokinetics, PK, Acidic Formulation, Acidic Beverage, Grapefruit Juice, Omeprazole, Fixed-sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-196Drug
Also called Acalabrutinib
In Parts 1, 2, and 3, participants will receive oral Dose 1 of ACP-196 (reference or acidic formulation as applicable) on Day 1, Day 3, Day 8, and Day 10.
OmeprazoleDrug
Participants will receive omeprazole in all parts as: on Day 8 and Day 10 with water in Part 1; on Day 8 with water and on Day 10 with acidic beverage in Part 2; on Day 8 with water and on Day 10 with grapefruit juice in Part 3.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Acidic formulation) | Experimental | In Part 1 of the study, the participants will receive Dose 1 of ACP-196 (reference or acidic formulation as applicable) with 240 mL water in 4 treatment schedules on Day 1, Day 3, Day 8 (with omeprazole), and Day 10 (with omeprazole). Receives: Drug: ACP-196; Drug: Omeprazole |
| Part 2 (Orange drink) | Experimental | In Part 2 of the study, the participants will receive Dose 1 of ACP-196 (reference formulation) with 240 mL water or acidic beverage as applicable in 4 treatment schedules on Day 1, Day 3, Day 8 (with omeprazole), and Day 10 (with omeprazole). Receives: Drug: ACP-196; Drug: Omeprazole |
| Part 3 (Grapefruit juice) | Experimental | In Part 3 of the study, the participants will receive Dose 1 of ACP-196 (reference formulation) with 240 mL water or grapefruit as applicable in 4 treatment schedules on Day 1, Day 3, Day 8 (with omeprazole), and Day 10 (with omeprazole). Receives: Drug: ACP-196; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of ACP-196 in Parts 1, 2, and 3
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Maximum Observed Plasma Concentration (Cmax) of ACP-196 in Parts 1, 2, and 3
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Secondary outcomes (17)
Percent of AUC0inf Extrapolated (AUC%extrap) of ACP-196 in Parts 1, 2, and 3
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours (AUC0-6h) of ACP-196 in Parts 1, 2, and 3
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours (AUC0-12h) of ACP-196 in Parts 1, 2, and 3
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ACP-196 in Parts 1, 2, and 3
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Apparent Terminal Elimination Rate Constant (λz) of ACP-196 in Parts 1, 2, and 3
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Apparent Terminal Elimination Half-life (T1/2) of ACP-196 in Parts 1, 2, and 3
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Apparent Total Plasma Clearance (CL/F) of ACP-196 in Parts 1, 2, and 3
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Apparent Total Volume of Distribution (Vz/F) of ACP-196 in Parts 1, 2, and 3
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h) of Omeprazole in Parts 1, 2, and 3
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours on Days 8 and 10
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-last) of Omeprazole in Parts 1, 2, and 3
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours on Days 8 and 10
Maximum Observed Plasma Concentration (Cmax) of Omeprazole in Parts 1, 2, and 3
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours on Days 8 and 10
Time of the Maximum Measured Plasma Concentration (Tmax) of Omeprazole in Parts 1, 2, and 3
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours on Days 8 and 10
Apparent Total Plasma Clearance (CL/F) of Omeprazole in Parts 1, 2, and 3
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours on Days 8 and 10
Apparent Total Volume of Distribution (Vz/F) of Omeprazole in Parts 1, 2, and 3
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours on Days 8 and 10
Number of Participants With Treatment emergent Adverse Events (TEAEs) and Treatment emergent Serious Adverse Events (TESAEs) in Parts 1, 2, and 3
Measured: From Day 1 through 14 days after the last dose (approximately 2 months)
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Parts 1, 2, and 3
Measured: From Day 1 through 24 hours post last dose on Day 10 (approximately 2 months)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Parts 1, 2, and 3
Measured: From Day 1 through 24 hours post last dose on Day 10 (approximately 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start28 Jan 2016
- Primary completion15 Mar 2016
- Study completion15 Mar 2016
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerta Pharma BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Priti Patel, MD, Study director, Acerta Pharma BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876807
- Sponsor's protocol ID
- ACE-HV-112
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 7 May 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 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Open-label, Fixed-sequence, 4-period, 3-part Study in Healthy Adult Subjects to Evaluate the Effect of an Acidic Formulation of Acalabrutinib (ACP-196), Acidic Beverage, or Grapefruit Juice on the Pharmacokinetics of Acalabrutinib Alone and Coadministered With Omeprazole
- ClinicalTrials.gov ID
- NCT04876807
- Acronym / sponsor ID
- ACE-HV-112
- Conditions
- Healthy Volunteers
- Keywords
- Acalabrutinib, ACP-196, Healthy volunteers, Pharmacokinetics, PK, Acidic Formulation, Acidic Beverage, Grapefruit Juice
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Acerta Pharma BVIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2016 (actual)
- Primary completion
- 15 Mar 2016 (actual)
- Study completion
- 15 Mar 2016 (actual)
- First posted
- 7 May 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 an acidic formulation of Acalabrutinib (ACP-196), acidic beverage, or grapefruit Juice on the PK of ACP-196 alone and coadministered with omeprazole.
Detailed description
This is a 3-part study. Each part of the study will compare the effect of an acidic formulation of ACP-196, acidic beverage (orange drink), or grapefruit juice on the PK profile of ACP-196 alone and when coadministered with omeprazole. Participants will be enrolled into Part 1 of the study first and then subsequent participants will be randomized in a 1:1 ratio to either Part 2 or Part 3 of the study. Participants will be screened within 28 days before the dose. Participants will be contacted approximately 14 days after the last dose of study drug administration to determine if any adverse event has occurred since the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Acidic formulation) | Experimental | Drug: ACP-196, Drug: OmeprazoleIn Part 1 of the study, the participants will receive Dose 1 of ACP-196 (reference or acidic formulation as applicable) with 240 mL water in 4 treatment schedules on Day 1, Day 3, Day 8 (with omeprazole), and Day 10 (with omeprazole). |
| Part 2 (Orange drink) | Experimental | Drug: ACP-196, Drug: OmeprazoleIn Part 2 of the study, the participants will receive Dose 1 of ACP-196 (reference formulation) with 240 mL water or acidic beverage as applicable in 4 treatment schedules on Day 1, Day 3, Day 8 (with omeprazole), and Day 10 (with omeprazole). |
| Part 3 (Grapefruit juice) | Experimental | Drug: ACP-196, Drug: OmeprazoleIn Part 3 of the study, the participants will receive Dose 1 of ACP-196 (reference formulation) with 240 mL water or grapefruit as applicable in 4 treatment schedules on Day 1, Day 3, Day 8 (with omeprazole), and Day 10 (with omeprazole). |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Continuous non-smoker who has not used nicotine-containing products for ≥ 3 months before 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, as deemed by the principal investigator (PI). Liver function tests must be =< the upper limit of normal range (ULN) at screening for inclusion.
- Men and women of reproductive potential to follow protocol defined contraception methods.
- Women must have negative serum pregnancy test results.
Key exclusion criteria (22 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.
- Participant with known fruit allergies.
- History or presence of clinically significant medical or psychiatric condition or disease (eg, cardiovascular, respiratory, hepatic, gastrointestinal, renal, genitourinary, endocrine, neuromuscular, rheumatologic, oncologic, cutaneous or other disorders), 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 subject by their participation in the study.
- Presence of any clinically significant, ongoing systemic bacterial, fungal or viral infections in the opinion of the PI.
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 |
|---|---|---|
| ACP-196Also: AcalabrutinibIn Parts 1, 2, and 3, participants will receive oral Dose 1 of ACP-196 (reference or acidic formulation as applicable) on Day 1, Day 3, Day 8, and Day 10. | Drug | Part 1 (Acidic formulation), Part 2 (Orange drink), Part 3 (Grapefruit juice) |
| OmeprazoleParticipants will receive omeprazole in all parts as: on Day 8 and Day 10 with water in Part 1; on Day 8 with water and on Day 10 with acidic beverage in Part 2; on Day 8 with water and on Day 10 with grapefruit juice in Part 3. | Drug | Part 1 (Acidic formulation), Part 2 (Orange drink), Part 3 (Grapefruit juice) |
Primary outcome
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
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of ACP-196 in Parts 1, 2, and 3
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Maximum Observed Plasma Concentration (Cmax) of ACP-196 in Parts 1, 2, and 3
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
17 secondary outcomes
Percent of AUC0inf Extrapolated (AUC%extrap) of ACP-196 in Parts 1, 2, and 3
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours (AUC0-6h) of ACP-196 in Parts 1, 2, and 3
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours (AUC0-12h) of ACP-196 in Parts 1, 2, and 3
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ACP-196 in Parts 1, 2, and 3
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Apparent Terminal Elimination Rate Constant (λz) of ACP-196 in Parts 1, 2, and 3
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Apparent Terminal Elimination Half-life (T1/2) of ACP-196 in Parts 1, 2, and 3
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Apparent Total Plasma Clearance (CL/F) of ACP-196 in Parts 1, 2, and 3
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Apparent Total Volume of Distribution (Vz/F) of ACP-196 in Parts 1, 2, and 3
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h) of Omeprazole in Parts 1, 2, and 3
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours on Days 8 and 10
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-last) of Omeprazole in Parts 1, 2, and 3
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours on Days 8 and 10
Maximum Observed Plasma Concentration (Cmax) of Omeprazole in Parts 1, 2, and 3
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours on Days 8 and 10
Time of the Maximum Measured Plasma Concentration (Tmax) of Omeprazole in Parts 1, 2, and 3
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours on Days 8 and 10
Apparent Total Plasma Clearance (CL/F) of Omeprazole in Parts 1, 2, and 3
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours on Days 8 and 10
Apparent Total Volume of Distribution (Vz/F) of Omeprazole in Parts 1, 2, and 3
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours on Days 8 and 10
Number of Participants With Treatment emergent Adverse Events (TEAEs) and Treatment emergent Serious Adverse Events (TESAEs) in Parts 1, 2, and 3
Time frame: From Day 1 through 14 days after the last dose (approximately 2 months)
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Parts 1, 2, and 3
Time frame: From Day 1 through 24 hours post last dose on Day 10 (approximately 2 months)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Parts 1, 2, and 3
Time frame: From Day 1 through 24 hours post last dose on Day 10 (approximately 2 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 7 May 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.
Priti Patel, MD study director
Acerta Pharma BV
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 ACP-196 and Omeprazole 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 6 inclusion and 22 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 7 May 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 From Time 0 to Time of Last Measurable Concentration (AUC0-last) of ACP-196 in Parts 1, 2, and 3 (time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, and 24 hours on Days 1, 3, 8, and 10). 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 7 May 2021.