Healthy VolunteersPhase 1NCT04905043

A Study to Evaluate the Effect of Gastric pH on Acalabrutinib Pharmacokinetics (PK) in Healthy Adult Participants

A Phase 1 study testing Acalabrutinib and SmartPill® in people with Healthy Volunteers, run by Acerta Pharma BV 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 evaluate the effect of gastric pH on acalabrutinib pharmacokinetics in healthy participants. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Acalabrutinib and SmartPill®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 3 Jun 2016to 11 Jul 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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Continuous nonsmoker 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 ECGs, as deemed by the principal investigator. Liver function tests, and serum bilirubin, must be <= upper limit of normal range (ULN) at screening.
Minimum of 1 bowel movement per day for >= 3 months before enrollment.
Women must be of non-childbearing status and must have negative serum pregnancy test results.
Men of reproductive potential to follow protocol defined contraception methods.

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 has any of the following contraindications for the SmartPill: A history of gastric bezoars, swallowing disorder, suspected or known strictures, fistulas or physiological/mechanical gastrointestinal (GI) obstruction, history of GI surgery within 3 months of administration, severe dysphagia to food or pills, Crohn's disease or diverticulitis, cardiac pacemakers or other implanted electromedical devices.
History or presence of alcoholism or drug abuse within the past 2 years before screening
History of bleeding diathesis
History of gastric motility disorder for example delayed gastric emptying, dumping syndrome, or irritable bowel disease.
History of constipation within the last year before enrollment

Show all 16Show fewer

Currently experiencing, or experienced within 2 weeks of enrollment, Grade 2 diarrhea
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 mmHg or > 140/90 mmHg at screening.
Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
Have been on a diet incompatible with the on study diet, in the opinion of the principal investigator (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 medications.
History or presence of liver disease and clostridium difficile-associated diarrhea.

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion
Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Phase 1, Single-center, Open-label, Fixed-sequence, 2-period Study in Healthy Adult Subjects to Evaluate the Effect of Gastric pH on Acalabrutinib Pharmacokinetics

This study will evaluate the effect of gastric pH on acalabrutinib pharmacokinetics in healthy participants.

Read the detailed description

This is a 2-period study done under fasting conditions. Participants will receive an oral wireless motility/pH capsule (SmartPill®) followed immediately by a single 100 mg oral dose of acalabrutinib on Day 1 of Period 1 and Period 2 (ie, Day 1 and Day 4, respectively). There will be 72 hours of washout between Day 1 dosing of each period. Participants will be contacted approximately 14 days after the last dose of study drug for adverse events.

Conditions: Healthy Volunteers
Being tested: Acalabrutinib, SmartPill®
Keywords: Acalabrutinib, ACP-196, Gastric pH, Healthy participants, Pharmacokinetics, PK, Safety

What participants receive

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

AcalabrutinibDrug
Also called ACP-196
Participants will receive a single oral dose of acalabrutinib 100 mg capsule on Day 1 (Period 1) and Day 4 (Period 2).
SmartPill®Drug
Participnats will receive a single oral dose of wireless motility/pH capsule (SmartPill®) on Day 1 (Period 1) and Day 4 (Period 2).

Study groups in NCT04905043
Study group	Role	What they receive
SmartPill® + Acalabrutinib	Experimental	Participants will receive 1 SmartPill® capsule followed immediately by a single oral dose of acalabrutinib 100 mg capsule on Day 1 (Period 1) and Day 4 (Period 2). There will be 72 hours of washout between acalabrutinib dosing of each period. Receives: Drug: Acalabrutinib; Drug: SmartPill®

What is being measured

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

Effect of Gastric pH and Emptying Rate on Acalabrutinib PK Parameters (Area Under Concentration-time Curve [AUC] From Time 0 to Last Measurable Concentration, AUC From Time 0 to Infinity, Maximum Observed Plasma Concentration [Cmax], Time to Reach Cmax)
Measured: 0, 3, 8, and 17 minutes post-ingestion event time (IET) in Periods 1 and 2
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-last) of Acalabrutinib
Measured: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Acalabrutinib
Measured: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Maximum Observed Plasma Concentration (Cmax) of Acalabrutinib
Measured: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2

Secondary outcomes (12)

Percent of AUC0-inf Extrapolated (AUC%extrap) of Acalabrutinib
Measured: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours (AUC0-6h) of Acalabrutinib
Measured: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours (AUC0-12h) of Acalabrutinib
Measured: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Acalabrutinib
Measured: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Apparent Terminal Elimination Rate Constant (λz) of Acalabrutinib
Measured: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Apparent Terminal Elimination Half-life (T1/2) of Acalabrutinib
Measured: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Apparent Total Plasma Clearance (CL/F) of Acalabrutinib
Measured: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Apparent Volume of Distribution (Vz/F) of Acalabrutinib
Measured: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Incidences of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Measured: Day 1 through 14 days after the last dose (approximately 1 month)
Incidences of Abnormal Vital Signs and Physical Examinations Reported as TEAEs
Measured: Day 1 to Day 5 for each participant
Incidences of Abnormal Electrocardiograms (ECGs) Reported as TEAEs
Measured: Day 1 to Day 5 for each participant
Incidences of Abnormal Clinical Laboratory Parameters Reported as TEAEs
Measured: Day 1 to Day 5 for each participant

Timeline

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

3 Jun 201611 Jul 2016

First posted27 May 2021
Study start3 Jun 2016
Primary completion11 Jul 2016
Study completion11 Jul 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04905043
Sponsor's protocol ID: ACE-HV-113
Status last verified: Jun 2021
First submitted: 24 May 2021
Last updated: 3 Jun 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 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, 2-period Study in Healthy Adult Subjects to Evaluate the Effect of Gastric pH on Acalabrutinib Pharmacokinetics
ClinicalTrials.gov ID: NCT04905043
Acronym / sponsor ID: ACE-HV-113
Conditions: Healthy Volunteers
Keywords: Acalabrutinib, ACP-196, Gastric pH, Healthy participants, Pharmacokinetics, PK, Safety
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Acerta Pharma BVIndustry (pharma, biotech, devices)
Study start: 3 Jun 2016 (actual)
Primary completion: 11 Jul 2016 (actual)
Study completion: 11 Jul 2016 (actual)
First posted: 27 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 gastric pH on acalabrutinib pharmacokinetics in healthy participants.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SmartPill® + Acalabrutinib	Experimental	Drug: Acalabrutinib, Drug: SmartPill®Participants will receive 1 SmartPill® capsule followed immediately by a single oral dose of acalabrutinib 100 mg capsule on Day 1 (Period 1) and Day 4 (Period 2). There will be 72 hours of washout between acalabrutinib dosing of each period.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Continuous nonsmoker 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 ECGs, as deemed by the principal investigator. Liver function tests, and serum bilirubin, must be <= upper limit of normal range (ULN) at screening.
Minimum of 1 bowel movement per day for >= 3 months before enrollment.
Women must be of non-childbearing status and must have negative serum pregnancy test results.

Key exclusion criteria (16 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 has any of the following contraindications for the SmartPill: A history of gastric bezoars, swallowing disorder, suspected or known strictures, fistulas or physiological/mechanical gastrointestinal (GI) obstruction, history of GI surgery within 3 months of administration, severe dysphagia to food or pills, Crohn's disease or diverticulitis, cardiac pacemakers or other implanted electromedical devices.
History or presence of alcoholism or drug abuse within the past 2 years before screening
History of bleeding diathesis
History of gastric motility disorder for example delayed gastric emptying, dumping syndrome, or irritable bowel disease.

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
AcalabrutinibAlso: ACP-196Participants will receive a single oral dose of acalabrutinib 100 mg capsule on Day 1 (Period 1) and Day 4 (Period 2).	Drug	SmartPill® + Acalabrutinib
SmartPill®Participnats will receive a single oral dose of wireless motility/pH capsule (SmartPill®) on Day 1 (Period 1) and Day 4 (Period 2).	Drug	SmartPill® + Acalabrutinib

Primary outcome

Effect of Gastric pH and Emptying Rate on Acalabrutinib PK Parameters (Area Under Concentration-time Curve [AUC] From Time 0 to Last Measurable Concentration, AUC From Time 0 to Infinity, Maximum Observed Plasma Concentration [Cmax], Time to Reach Cmax)
Time frame: 0, 3, 8, and 17 minutes post-ingestion event time (IET) in Periods 1 and 2
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-last) of Acalabrutinib
Time frame: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Acalabrutinib
Time frame: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Maximum Observed Plasma Concentration (Cmax) of Acalabrutinib
Time frame: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2

12 secondary outcomes

Percent of AUC0-inf Extrapolated (AUC%extrap) of Acalabrutinib
Time frame: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours (AUC0-6h) of Acalabrutinib
Time frame: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours (AUC0-12h) of Acalabrutinib
Time frame: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Acalabrutinib
Time frame: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Apparent Terminal Elimination Rate Constant (λz) of Acalabrutinib
Time frame: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Apparent Terminal Elimination Half-life (T1/2) of Acalabrutinib
Time frame: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Apparent Total Plasma Clearance (CL/F) of Acalabrutinib
Time frame: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Apparent Volume of Distribution (Vz/F) of Acalabrutinib
Time frame: pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose in Periods 1 and 2
Incidences of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 through 14 days after the last dose (approximately 1 month)
Incidences of Abnormal Vital Signs and Physical Examinations Reported as TEAEs
Time frame: Day 1 to Day 5 for each participant
Incidences of Abnormal Electrocardiograms (ECGs) Reported as TEAEs
Time frame: Day 1 to Day 5 for each participant
Incidences of Abnormal Clinical Laboratory Parameters Reported as TEAEs
Time frame: Day 1 to Day 5 for each participant

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 3 Jun 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 and SmartPill® 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 16 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 Jun 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?

Effect of Gastric pH and Emptying Rate on Acalabrutinib PK Parameters (Area Under Concentration-time Curve [AUC] From Time 0 to Last Measurable Concentration, AUC From Time 0 to Infinity, Maximum Observed Plasma Concentration [Cmax], Time to Reach Cmax) (time frame: 0, 3, 8, and 17 minutes post-ingestion event time (IET) in Periods 1 and 2). The study lists 4 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 NCT04905043.

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 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.