A Phase 1 interventional study of ACP-196 and Calcium carbonate in Healthy Participants, sponsored by Acerta Pharma BV. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-07.
Sponsored by Acerta Pharma BV · Phase 1, Interventional, and Treatment
The study will evaluate one-way interaction of calcium carbonate, omeprazole, or rifampin on ACP-196.
This is a 3-part study. Each part will be conducted as an open-label, 2-period, fixed-sequence study. All the study parts will be conducted concurrently and the participants will receive the study treatment in all the parts after an overnight fast. In each part, 24 healthy, non-tobacco using, men and women will be enrolled, to ensure 22 participants complete each part. Each participant will participate in only one study part. In Part 1, a single oral dose of ACP-196 100 mg capsule will be administered on Day 1 of Period 1 (Treatment A), and a single oral dose of calcium carbonate 1 g tablets will be coadministered with a single oral dose of ACP-196 100 mg on Day 1 of Period 2 (Treatment B). In Part 2, a single oral dose of ACP-196 100 mg capsule will be administered on Day 1 pf Period 1 (Treatment C) and oral doses of omeprazole 40 mg capsules once daily (QD) for 5 consecutive days with a single oral dose of ACP-196 100 mg capsule coadministered on Day 5 of Period 2 (Treatment D). In Part 3, a single oral dose of ACP-196 will be administered on Day 1 of Period 1 (Treatment E) and oral dose of rifampin 600 mg capsule QD for 9 consecutive days with a single oral dose of ACP-196 100 mg capsule coadministered on Day 1 and Day 9. Participants will be screened within 28 days before the dose. There will be no washout between the dose in Period 1 and the first dose in Period 2. Participants will be contacted approximately 14 days after the last dose of study drug for adverse events.
Acerta Pharma BV is the lead sponsor of 40 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 3 (25%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Part 1 Only:
Part 2 Only:
Part 3 Only:
Participants will receive a single oral dose of ACP-196 100 mg capsule on Day 1 of Period 1 and a single oral dose of calcium carbonate 1 g tablet coadministered with a single oral dose of ACP-196 100 mg capsule on Day 1 of Period 2.
Drug: ACP-196 · Drug: Calcium carbonate
Participants will receive a single oral dose of ACP-196 100 mg capsule on Day 1 of Period 1 and oral dose of omeprazole 40 mg capsules once daily (QD) for 5 consecutive days coadministered with a single oral dose of ACP-196 100 mg capsule on Day 5 of Period 2.
Drug: ACP-196 · Drug: Omeprazole
Participants will receive a single oral dose of ACP-196 100 mg capsule on Day 1 of Period 1 and oral dose of rifampin 600 mg capsule QD for 9 consecutive days coadministered with a single oral dose of ACP-196 100 mg capsule on Day 1 and Day 9 of Period 2.
Drug: ACP-196 · Drug: Rifampin
Participants will receive a single oral dose of ACP-196 100 mg capsule on Day 1 of Period 1 in Part 1, Part 2, and Part 3; and on Day 1 of Period 2 in Part 1, Day 5 of Period 2 in Part 2, and Day 1 and Day 9 of Period 2 in Part 3.
Also known as: Acalabrutinib
Participants will receive a single oral dose of calcium carbonate 1 g tablet on Day 1 of Period 2 in Part 1.
Participants will receive multiple oral doses of omeprazole 40 mg capsules QD for 5 consecutive days in Period 2 of Part 2.
Participants will receive multiple oral doses of rifampin 600 mg capsule QD for 9 consecutive days in Period 2 of Part 3.
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: Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3
Maximum Observed Plasma Concentration (Cmax) of ACP-196 in Parts 1, 2, and 3
Time frame: Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3
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: Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3
Percent of AUC0inf Extrapolated (AUC%extrap) of ACP-196 in Parts 1, 2, and 3
Time frame: Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3
Area Under the Plasma Concentration-time Curve From Time 0 to 24 hours (AUC0-24h) of ACP-196 in Parts 1, 2, and 3
Time frame: Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ACP-196 in Parts 1, 2, and 3
Time frame: Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3
Apparent Terminal Elimination Half-life (T1/2) of ACP-196 in Parts 1, 2, and 3
Time frame: Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3
Apparent Terminal Elimination Rate Constant (λz) of ACP-196 in Parts 1, 2, and 3
Time frame: Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3
Apparent Total Body Clearance (CL/F) of ACP-196 in Parts 1, 2, and 3
Time frame: Period 1: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for all parts; Period 2: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs on Day 1 for Part 1, on Day 5 for Part 2, and on Days 1 and 9 for Part 3
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events in Parts 1, 2, and 3
Time frame: From Day 1 through 14 days after the last dose (approximately 1 month) in all 3 parts
Number of Participants With Abnormal Physical Examinations and Vital Signs Reported as TEAEs in Parts 1, 2, and 3
Time frame: Part 1: Day 1; Part 2: Day 1 through Day 5; Part 3: Day 1 through Day 9
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs in Parts 1, 2, and 3
Time frame: Part 1: Day 1; Part 2: Day 1 through Day 5; Part 3: Day 1 through Day 9
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Parts 1, 2, and 3
Time frame: Part 1: Day 1; Part 2: Day 1 through Day 5; Part 3: Day 1 through Day 9
Plan to share: 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.
No publications or documents are linked to this record.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acerta Pharma BV