Clinical trials: sponsored by Eisai Inc.
Healthy Participants
Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730
Study E2730-A001-001 is a first-in-human, sequential ascending single dose, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single oral dose of E2730 in healthy participants.
- Trial name
- NCT03054194
- Testing
- E2730
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Participants
Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects
This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study of lemborexant in healthy adult and elderly subjects to evaluate driving performance
- Trial name
- NCT02583451
- Testing
- Zopiclone 7.5 mg, Lemborexant 2.5 mg, Lemborexant 5 mg
- Where
- Netherlands
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Parkinson's Disease
Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECT
This is a two-arm, double-blind, placebo-controlled study.
- Trial name
- NCT00566462
- Testing
- perampanel
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- Eisai Inc.
Healthy Subjects
Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects
This study will be conducted to evaluate the effect of lemborexant 10 milligrams (mg) (at steady state) on the pharmacokinetics (PK) of a single-dose combined oral contraceptive, Loestrin 1.5/30 (containing 0.030 mg of ethinyl…
- Trial name
- NCT03451110
- Testing
- lemborexant, Loestrin, famotidine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Down Syndrome, Cognitive Dysfunction
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17
The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of the cognitive dysfunction shown by children with Down syndrome, aged 11 to 17.
- Trial name
- NCT00754052
- Testing
- Aricept (donepezil hydrochloride)
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Eisai Inc.
Idiopathic Thrombocytopenic Purpura
Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003
The purpose of this study is to determine the safety and efficacy of AKR-501 (avatrombopag) administered in participants with chronic Idiopathic Thrombocytopenic Purpura (ITP) who were enrolled into and completed 28 days of study…
- Trial name
- NCT00625443
- Testing
- Open Label (Avatrombopag tablets), Blinded (Avatrombopoag tablets)
- Where
- 12 sites in United States
- Volunteers
- 53 people
- Sponsor
- Eisai Inc.
Chronic Idiopathic Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Idiopathic
Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
The purpose of this study is to determine the efficacy, safety and tolerability, of AKR-501 (avatrombopag) tablets, as compared to placebo, in the treatment of participants with chronic Idiopathic Thrombocytopenic Purpura (ITP).
- Trial name
- NCT00441090
- Testing
- Avatrombopag tablets
- Where
- 25 sites in United States
- Volunteers
- 64 people
- Sponsor
- Eisai Inc.
Thrombocytopenia Associated With Liver Disease
Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure
This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease.
- Trial name
- NCT01976104
- Testing
- avatrombopag (lower baseline platelet count), avatrombopag (higher baseline platelet count)
- Where
- 120 sites in United States, Argentina and 15 more
- Volunteers
- 204 people
- Sponsor
- Eisai Inc.
Thrombocytopenia Associated With Liver Disease
Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective Procedure
This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease.
- Trial name
- NCT01972529
- Testing
- avatrombopag (lower baseline platelet count), avatrombopag (higher baseline platelet count)
- Where
- 109 sites in United States, Argentina and 18 more
- Volunteers
- 231 people
- Sponsor
- Eisai Inc.
Thrombocytopenia
Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501
To evaluate the efficacy of E5501 by measuring platelet response in subjects with chronic hepatitis C virus (HCV)-related thrombocytopenia who require antiviral treatment.
- Trial name
- NCT01355289
- Testing
- Avatrombopag, Pegylated interferon (PEG-IFN), Telaprevir
- Where
- 2 sites in United States
- Volunteers
- 65 people
- Sponsor
- Eisai Inc.
Healthy Participants
A Study to Evaluate the Food-Effect of H3B-6527
This study will be conducted to determine the effect of food on the relative bioavailability of H3B-6527 following administration of a H3B-6527 capsule with and without a meal.
- Trial name
- NCT03424577
- Testing
- H3B-6527
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Idiopathic Thrombocytopenic Purpura
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)
Core study: To compare the efficacy of avatrombopag (in addition to standard) of care to eltrombopag (in addition to standard of care) for the treatment of adult participants with chronic immune thrombocytopenia (idiopathic…
- Trial name
- NCT01433978
- Testing
- Eltrombopag, Avatrombopag, Standard of care
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Eisai Inc.
Chronic Thrombocytopenia, Immune Thrombocytopenia
Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Amendment 02)
Core Study: To demonstrate that the efficacy of avatrombopag (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult participants with chronic immune thrombocytopenia…
- Trial name
- NCT01438840
- Testing
- Avatrombopag, Standard of care
- Where
- 25 sites in Australia, Belgium and 9 more
- Volunteers
- 49 people
- Sponsor
- Eisai Inc.
Thrombocytopenia Related to Chronic Liver Disease
Once-Daily Oral Avatrombopag Tablets Used in Subjects With Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures
The purpose of this study is to evaluate the efficacy of once-daily Oral avatrombopagin subjects with chronic liver diseases and thrombocytopenia prior to elective surgical or diagnostic procedures, to evaluate the safety of…
- Trial name
- NCT00914927
- Testing
- Avatrombopag
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Eisai Inc.
Non-Small Cell Lung Cancer
A Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different Treatments
The purpose of this study is to compare the overall survival of patients receiving E7080 + Best Supportive Care (BSC) with those receiving placebo + Best Supportive Care.
- Trial name
- NCT01529112
- Testing
- Lenvatinib, BSC
- Where
- 50 sites in United States, Belgium and 5 more
- Volunteers
- 135 people
- Sponsor
- Eisai Inc.
Advanced Colorectal Cancer
A Phase II Study of the Safety and Efficacy of E7820 Plus Cetuximab in Colorectal Cancer, Preceded by a Run-in Study in Advanced Solid Tumors
This study proposes to determine the safety of the administration of E7820 plus cetuximab and explore the MTD of the combination in a Phase Ib study.
- Trial name
- NCT00309179
- Testing
- E7820 plus cetuximab
- Where
- 3 sites in United States, Canada
- Volunteers
- 41 people
- Sponsor
- Eisai Inc.
Seizure Disorder Generalized Tonic Clonic
A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures
This study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of perampanel on Primary Generalized Tonic Clonic (PGTC) seizure frequency in adolescents and adults maintained on one to two stable antiepileptic…
- Trial name
- NCT01393743
- Testing
- Perampanel
- Volunteers
- 163 people
- Sponsor
- Eisai Inc.
Severe Sepsis
ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
The purpose of this study is to compare eritoran tetrasodium and placebo in patients with severe sepsis and to demonstrate a reduction of mortality from all causes.
- Trial name
- NCT00334828
- Testing
- eritoran tetrasodium
- Where
- 251 sites in United States, Argentina and 22 more
- Volunteers
- 2,000 people
- Sponsor
- Eisai Inc.
Advanced Solid Tumors, Lymphomas
A Study to Determine the Metabolism and Elimination of 14C-E7080 in Patients With Advanced Solid Tumors or Lymphomas, Who Are Unsuitable For, or Have Failed, Existing Therapies.
The purpose of this study was to determine the metabolism and elimination of 14C-lenvatinib in participants with advanced solid tumors or lymphomas, who were unsuitable for, or had failed, existing therapies.
- Trial name
- NCT02578316
- Testing
- Lenvatinib
- Where
- Netherlands
- Volunteers
- 6 people
- Sponsor
- Eisai Inc.
Early Alzheimer's Disease
A Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy Subjects
The primary objective of the study is to evaluate the effects of hepatic impairment on the pharmacokinetics (PK) of E2609 after a single dose administration.
- Trial name
- NCT02859207
- Testing
- E2609
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.