NCT04876807 is a Phase 1 clinical trial of ACP-196 in Healthy Volunteers, sponsored by Acerta Pharma BV.

Who is sponsoring NCT04876807?

NCT04876807 is sponsored by Acerta Pharma BV.

What drugs are being tested in NCT04876807?

Interventions in NCT04876807: ACP-196, Omeprazole.

What condition does NCT04876807 study?

NCT04876807 studies Healthy Volunteers.

Is NCT04876807 still recruiting?

NCT04876807 is currently completed. Last updated 7 May 2021.

Last reviewed 2021-05-07 · How we verify

NCT04876807

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 7 May 2021

What this trial tests

Phase 1 trial testing ACP-196 in Healthy Volunteers in 36 participants. Completed in 15 March 2016.

Timeline

28 January 2016

Primary endpoint
15 March 2016

15 March 2016

Quick facts

Lead sponsor	Acerta Pharma BV
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	28 January 2016
Primary completion	15 March 2016
Estimated completion	15 March 2016
Sites	1 location across United States

Drugs / interventions tested

ACP-196 — full drug profile →
Omeprazole (omeprazole) — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Acerta Pharma BV — full company profile →

Who can join

Adults 19 to 65, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of ACP-196

Trials testing the same drug.

NCT04867980 — A Study to Evaluate the Effect of ACP-196 on the Heart Rate-corrected QT Interval in Healthy Adult Participants · Phase 1 · completed
NCT02586857 — A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM) · Phase 1, PHASE2 · active not recruiting
NCT04867941 — A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics (PK) of ACP-196 · Phase 1 · completed
NCT04914936 — A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196 · Phase 1 · completed
NCT04901923 — A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, Food Effects, and Drug-drug Interactions of ACP-196 in H · Phase 1 · completed

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Acerta Pharma BV trials

Trials by the same sponsor.

NCT04529772 — A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) · Phase 3 · active not recruiting
NCT04497948 — Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19 · Phase 1 · terminated
NCT05140096 — A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and Its Active Metabolite (ACP-5862) When Admin · Phase 1 · completed
NCT03836261 — Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus · Phase 3 · active not recruiting
NCT03968848 — Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04876807 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Acerta Pharma BV
Last refreshed: 7 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04876807.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing