Clinical trials: sponsored by Acerta Pharma BV
Healthy Volunteers
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
This study will evaluate the effect of fluconazole and isavuconazole on the PK of acalabrutinib and its active metabolite, ACP-5862.
- Trial name
- NCT05140096
- Testing
- Acalabrutinib, Fluconazole, Isavuconazole
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Hepatic Impairment, Hepatic Insufficiency
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.
- Conditions
- Hepatic Impairment, Hepatic Insufficiency, Healthy Subjects
- Trial name
- NCT03968848
- Testing
- acalabrutinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Healthy Participants
A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196
The study will evaluate one-way interaction of calcium carbonate, omeprazole, or rifampin on ACP-196.
- Trial name
- NCT04914936
- Testing
- ACP-196, Calcium carbonate, Omeprazole
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Healthy Volunteers
A Study to Evaluate the Effect of Gastric pH on Acalabrutinib Pharmacokinetics (PK) in Healthy Adult Participants
This study will evaluate the effect of gastric pH on acalabrutinib pharmacokinetics in healthy participants.
- Trial name
- NCT04905043
- Testing
- Acalabrutinib, SmartPill®
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Healthy Participants
A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, Food Effects, and Drug-drug Interactions of ACP-196 in Healthy Participants
This study is to evaluate the safety, pharmacokinetics/pharmacodynamics (PK/PD), food-effect, and drug-drug interaction study of ACP-196 in healthy participants.
- Trial name
- NCT04901923
- Testing
- ACP-196, Itraconazole
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Healthy Volunteers
A Study to Evaluate the Effect of [14C]Acp-196 (Acalabrutinib) in Healthy Adult Participants
This study is to determine the absolute bioavailability of oral acalabrutinib and intravenous (IV) PK of [14C]ACP-196.
- Trial name
- NCT04898101
- Testing
- Acalabrutinib, Microtracer [14C]ACP-196
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Healthy Volunteers
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
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.
- Trial name
- NCT04876807
- Testing
- ACP-196, Omeprazole
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Hepatic Insufficiency
A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics (PK) of ACP-196
The study will evaluate the influence of hepatic insufficiency on the PK of ACP-196.
- Trial name
- NCT04867941
- Testing
- ACP-196
- Where
- 3 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Healthy Volunteers
A Study to Evaluate the Effect of ACP-196 on the Heart Rate-corrected QT Interval in Healthy Adult Participants
This study is to evaluate the effects of single therapeutic and supratherapeutic oral doses of ACP-196 on the heart rate-corrected QT interval using Fridericia's formula (QTcF).
- Trial name
- NCT04867980
- Testing
- ACP-196, Moxifloxacin 400 mg
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV