Select Page

PKI Studies Conducted

BioPharma Services has completed a wide range of Protein Kinase Inhibitor (PKI) Studies. Understand our experience below.

At BioPharma Services, we offer expertise in the execution and analysis of Pharmacokinetic Studies. These are investigations designed to assess how different drugs interact within the body, and how those interactions may influence drug metabolism and effects. Our comprehensive PK studies provide crucial insights into pharmacokinetics that can provide further assessment on comparability bioavailability, safety and efficiency. 

We have diverse experience in most therapeutic areas and different drug classes, including antineoplastic agents. The kinase inhibitors – protein kinase inhibitor (PKI), are a large group that specifically targets protocol kinases activities, which are involved in many important cell functions such as cell signalling, growth and division. Multiple PKIs have been introduced since the last 20 years, providing patients with more treatment options with higher efficiency and lower risk profiles. We are adept at performing PK studies with PKI agents in normal, healthy volunteers. Our meticulous and rigorous evaluation process has resulted in numerous PKIs being reviewed and deemed acceptable to dose in normal, healthy volunteers. 

BioPharma Services’ expertise in these areas assures our global drug development clients of our ability to generate reliable and high-quality data, ultimately accelerating the drug development process, minimizing risks, and improving the potential for regulatory success.

TKIs & Designs for Studies in Normal Healthy Volunteers

RLDTKIsBE Study Design (Both Fast & Fed)
Calquence®AcalabrutinibSingle dose, 3-way crossover pilot
Gleevec®ImatinibSingle dose (400 mg), 2-way crossover
IbrancePabociclibSingle dose (125mg), 2-way crossover
Imbruvica®IbrutinibSingle dose (560 mg), 4-way fully replicate
Inlyta®AxitinibSingle dose (5 mg), 3-way partial-replicate
Iressa®GefitinibSingle dose (250 mg), 2-way crossover and 4-way fully replicate
Kisqali®RibociclibSingle dose (200 mg), 3-way crossover (pilot)
Lenvima®LenvatinibSingle dose 10 mg, (4-way fully replicate)
Nerlynx®NeratinibSingle dose (240mg), 3-way crossover pivotal
Nexavar®SorafenibSingle dose (200 mg), 2-way crossover and 4-way fully replicate
Sprycel®DasatinibSingle dose (100 mg or 140 mg), 4-way fully replicate
Stivarga®RegorafenibSingle dose (40 mg), 2-way crossover
Sutent®SunitinibSingle dose (50 mg), 2-way crossover
Tarceva®ErlotinibSingle dose (150 mg), 2-way crossover
Votrient®PazopanibSingle dose (400 mg), 2-way crossover and 4-way fully replicate
Xeljanz®TofacitinibSingle dose (5mg), 2-way crossover
Zydelig®IdelalisibSingle dose (150mg), 2-way crossover
Rydapt®MidostaurineSingle dose (25 mg), parallel

PKIs Reviewed & Deemed Acceptable to Dose in Normal Healthy Volunteers

Brand NameActive Ingredient
AlbunbrigBrigatinib
AlecensaAlectinib Hydrochloride
AyvakitAvapritinib
BalversaErdafitinib
BosulifBosutinib Monohydrate
BrukinsaZanubrutinib
Cabometyx tabletCabozantinib S-Malate
CalquenceAcalabrutinib
CaprelsaVandetanib
Cometriq capsuleCabozantinib S-Malate
CotellicCobimetinib Fumarate
Dabrafenib*Tafinlar
ErivedgeVismodegib
GilotrifAfatinib Dimaleate
GleevecImatinib Mesylate
IbrancePalbociclib (CDKI)
IclusigPonatinib Hydrochloride
IdhifaEnasidenib
ImbruvicaIbrutinib
InlytaAxitinib
InrebicFedratinib hydrochloride
IressaGefitinib
JakafiRuxolitinib Phosphate
Kisqali®Ribociclib
LenvimaLenvatinib Mesylate
MidostaurinRydapt
NerlynxNeratinib
NexavarSorafenib Tosylate
OfevNintedanib Esylate
OlumiantBaricitinib
RinvoqUpadacitinib
RozlytrkEntrectinib
SprycelDasatinib
StivargaRegorafenib
SutentSunitinib Malate
TagrissoOsimertinib Mesylate
TarcevaErlotinib Hydrochloride
TasignaNilotinib Hydrochloride Monohydrate
TavalisseFostamatinib
Trametinib*Mekinist
TuralioPexidartinib hydrochloride
VotrientPazopanib Hydrochloride
XalkoriCrizotinib
XeljanzTofacitinib Citrate
Zydelig®Idelalisib
ZykadiaCeritinib

Want a Personal Copy?

Click Here to download a PDF copy of our Conducted PKI Studies.

Schedule a Discovery Call

 Learn how BioPharma Services can be your trusted clinical trial partner.