Study to Assess the Relative Bioavailability of Pacritinib Following Oral Administration as Capsule and Solution Formulations in Healthy Subjects
NCT02808455 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2023-09-15
Summary
This was a randomized, 2-period, 2-treatment-sequence crossover study to determine the relative bioavailability of pacritinib following administration as a 400 mg oral dose of four 100 mg pacritinib capsules and an 80 mg dose of an oral solution and to characterize the PK and major human metabolites of pacritinib.
Conditions
- Healthy Subjects
Interventions
- DRUG
-
(Treatment A)
Four 100-mg capsules of pacritinib administered as a single oral dose
- DRUG
-
(Treatment B)
A single 80-mg oral solution dose of pacritinib
Sponsors & Collaborators
-
Covance
collaborator INDUSTRY -
CTI BioPharma
lead INDUSTRY
Principal Investigators
-
Hugh Coleman, DO · Covance Clinical Research Unit
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2015-03-31
- Completion
- 2015-03-31
Countries
- United States
Study Locations
More Related Trials
-
Relative Bioavailability For Palbociclib Formulations
NCT02083640 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Bioavailability of 1 mg and 10 mg BI 1356 BS as Powder in the Bottle (PIB) to 1 mg and 10 mg BI 1356 BS as Tablets as Single Oral Administration in Healthy Male Volunteers Including the Influence of Food on the Bioavailability of 10 mg BI 1356 BS
NCT02180503 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess Relative Bioavailability of Branebrutinib, From a Tablet Formulation to the Capsule Formulation, the Effect of Food on the Bioavailability of Branebrutinib From a Tablet Formulation, and the Safety and Drug Levels of Branebrutinib From a Tablet Formulation in Healthy Participants
NCT05303220 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study of JNJ-42756493 in Healthy Participants
NCT02218073 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Relative Bioavailability of Two Different Pimicotinib Capsules in Healthy Subjects
NCT06694948 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants
NCT05051553 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.
NCT01571570 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic, Bioavailability, and Safety Study of COV155 Administered in Healthy Subjects Under Fed and Fasted Conditions
NCT02561741 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Determine the Relative Oral Bioavailability of Single Dose Administration of TMC207, Under Fed and Fasted Conditions in Healthy Participants
NCT00946842 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Bosutinib Administered Orally to Healthy Subjects
NCT00721474 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Oral Bioavailability of BI 44847 as Suspension Compared to Tablet and the Influence of Food Anf of BI 44847 as Solution Compared to Tablet in Healthy Male Volunteers
NCT02211937 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food
NCT01286571 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1 Bioavailability Study of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects
NCT02034565 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Relative Bioavailability of Pimicotinib Capsules Containing Free Base in Different Proportions in Healthy Subjects
NCT07210996 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study to Evaluate the Effect of Food on Pharmacokinetics of ASTX029
NCT04466514 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Merestinib (LY2801653) in Healthy Participants
NCT02779738 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Absolute Bioavailability Study For Oral Crizotinib In Healthy Volunteers
NCT01168934 ·Status: COMPLETED ·Phase: PHASE1
-
A Study In Healthy Volunteers To Estimate The Effect Of The Active Ingredient Particle Size And Percentage Of The Excipients Used To Formulate The Capsules In The Dissolution Rate Of The Formulations In The Gastrointestinal Tract
NCT01844323 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body
NCT05707403 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants
NCT06566768 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Bioavailability of BI 1467335 Tablet and Oral Solution, and Food Effect on Tablet in Healthy Male Subjects
NCT02999191 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Relative Bioavailability and Food Effect of GDC-9545 in Healthy Females of Non-Childbearing Potential
NCT04274075 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Bioavailability Study
NCT01602887 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers
NCT01731327 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Learn About How Different Forms of the Study Medicine Called Ritlecitinib Pass the Intestines of Healthy Male Adults When Taken With or Without Food
NCT06369454 ·Status: COMPLETED ·Phase: PHASE1