A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects
NCT02039076 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2014-12-18
Summary
This will be a randomized, open-label, 5-treatment-period study to evaluate the PK and PD of avatrombopag following a single administration of avatrombopag in the fed and fasted condition, or the fed condition, to healthy Japanese and white subjects. A standard high-fat, high calorie breakfast will be used to assess the fed condition.
Conditions
Interventions
- DRUG
-
avatrombopag
Sponsors & Collaborators
-
Eisai Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-12-31
- Primary Completion
- 2014-06-30
- Completion
- 2014-09-30
Countries
- United States
Study Locations
More Related Trials
-
Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment
NCT00359463 ·Status: COMPLETED ·Phase: PHASE1
-
Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure
NCT03554759 ·Status: TERMINATED
-
Phase 2, Pharmacokinetics Study of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver Disease
NCT00861601 ·Status: COMPLETED ·Phase: PHASE2
-
Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective Procedure
NCT01972529 ·Status: COMPLETED ·Phase: PHASE3
-
Open-Label Study to Evaluate the Safety and Efficacy of Avatrombopag and Remission Rates in Adults With ITP of ≤6 Months
NCT05046327 ·Status: WITHDRAWN ·Phase: PHASE3
-
Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma
NCT04797182 ·Status: UNKNOWN ·Phase: PHASE2
-
Avatrombopag Combined With All-trans Retinoic Acid in the Treatment of Primary Immune Thrombocytopenia
NCT07278908 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2/PHASE3
-
Exploring the Efficacy, Safety of a Modified Starting Dosage of Avatrombopag in Immune Throbocytopenia (ITP) - a Pilot Study
NCT07133659 ·Status: RECRUITING ·Phase: PHASE4
-
Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia
NCT06281327 ·Status: RECRUITING ·Phase: PHASE2
-
A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura)
NCT01433978 ·Status: TERMINATED ·Phase: PHASE3
-
Avatrombopag for Chemotherapy-induced Thrombocytopenia
NCT05218226 ·Status: RECRUITING ·Phase: PHASE2
-
Avatrombopag Usage in NSAA
NCT04728789 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Avatrombopag in the Treatment of Primary Immune Thrombocytopenia(ITP)
NCT04949009 ·Status: UNKNOWN
-
A Trial of Hetrombopag in Healthy and Hepatic Impairment Subjects
NCT05088642 ·Status: COMPLETED ·Phase: PHASE1
-
Eltrombopag Phase III Study In Chinese Chronic ITP Patients
NCT01762761 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Avatrombopag in Cancer Patients With Thrombocytopenia
NCT04896528 ·Status: UNKNOWN ·Phase: PHASE2
-
Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects
NCT01327872 ·Status: COMPLETED ·Phase: PHASE1
-
A Rollover Study to Provide Continued Treatment With Eltrombopag
NCT01957176 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Hetrombopag in Non-severe Aplastic Anemia
NCT05018936 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia
NCT05369377 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Hetrombopag for Lower-risk MDS With Thrombocytopenia: a Prospective,Open-label, Single-arm Study.
NCT05392647 ·Status: UNKNOWN ·Phase: PHASE2
-
Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure
NCT03326843 ·Status: TERMINATED ·Phase: PHASE3
-
Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim
NCT04638829 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy of Avatrombopag in Thrombocytopenic Patients With Chronic Liver Disease Undergoing an Elective Procedure
NCT04915287 ·Status: UNKNOWN ·Phase: PHASE4
-
Eltrombopag in Second Line Adult Primary Immune Thrombosytopenia
NCT02402998 ·Status: COMPLETED ·Phase: PHASE2