Clinical trials: sponsored by Eisai Inc.
Healthy Volunteers
A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants
The primary purpose of this study is to assess potential drug-drug interactions of E2086 when coadministered orally with Itraconazole, Carbamazepine, Midazolam, Dextromethorphan, Bupropion, or Combined Oral Contraceptives in…
- Trial name
- NCT07766369
- Testing
- E2086
- Where
- United States
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants
The primary purpose of this study is to determine the metabolism and excretion of [14C]E2086 in healthy male participants.
- Trial name
- NCT07308236
- Testing
- E2086
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Malaria, Healthy Participants
A Study of Oral E1018 in Healthy Adult Participants
The primary purpose of the study is to evaluate the safety and tolerability of single ascending oral doses of E1018 in healthy adult participants and to evaluate the pharmacokinetics (PK) of E1018 in plasma and urine after single…
- Trial name
- NCT06854042
- Testing
- E1018
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Sleep Initiation and Maintenance Disorders, Pregnancy
A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population
The primary purpose of the study is to compare the occurrence of major congenital malformations (MCMs) among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with…
- Trial name
- NCT06744673
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 861 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study of E2086 in Healthy Adult Participants
The primary purpose of the study is to evaluate the safety and tolerability following multiple ascending doses of E2086 in healthy adult participants.
- Trial name
- NCT06481488
- Testing
- E2086
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2086 in Healthy Adult and Elderly Participants
The primary objective of this study is to evaluate the safety and tolerability of E2086 following administration of a single oral doses in healthy adult and elderly participants.
- Trial name
- NCT05745207
- Testing
- E2086
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of E2025 in Healthy Participants
The primary purpose of the study is to evaluate the safety and tolerability of single intravenous (IV) infusions of E2025 in healthy adult participants.
- Trial name
- NCT05726851
- Testing
- E2025
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Refractory Solid Tumors, Lymphomas
A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval
This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled, three-treatment, three-way crossover study in healthy subjects. There are two phases in this study: Pre-Randomization and Randomization.
- Trial name
- NCT01525394
- Testing
- Lenvatinib, Moxifloxacin 400 mg
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Assess Safety, Tolerability, Pharmacokinetics (PK), Immunogenicity, and Pharmacodynamics (PD) of Intravenous Infusions of E2814 in Healthy Participants
The primary objective of this study is to evaluate the safety and tolerability of single and multiple intravenous infusions of E2814 in healthy adult participants.
- Trial name
- NCT04231513
- Testing
- E2814
- Where
- 2 sites in United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
The primary purpose of this study is to demonstrate the bioequivalence (BE) of a single subcutaneous (SC) dose of lecanemab via vial and AI in healthy participants.
- Trial name
- NCT05533801
- Testing
- Lecanemab
- Where
- United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Assess the Safety and Tolerability of E2511 in Healthy Adult and Elderly Participants
The primary objective of this study is to evaluate the safety, tolerability, and plasma pharmacokinetic (PK) of E2511 following multiple oral doses in healthy adult participants.
- Trial name
- NCT05147337
- Testing
- E2511
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study of Subcutaneous Lecanemab in Healthy Participants
The primary purpose of this study is to determine the absolute bioavailability and pharmacokinetic (PK) profile of a single dose of lecanemab when administered subcutaneously (SC) in healthy participants.
- Trial name
- NCT05045716
- Testing
- Lecanemab
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women
The primary purpose of the study is to estimate the cumulative amount of lemborexant excreted in breast milk following a single dose administration of lemborexant 10 milligram (mg) to healthy lactating women and to estimate the…
- Trial name
- NCT04890561
- Testing
- Lemborexant
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Assess the Safety and Tolerability of E2730 After Multiple Dose and the Food Effect After Single Dose in Healthy Participants
The primary purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E2730 of multiple ascending oral doses in healthy adult participants and to assess the differences in PK, safety, and…
- Trial name
- NCT04676685
- Testing
- E2730
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Obesity
Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years
This study will be conducted to demonstrate weight loss efficacy by change in body mass index (BMI) and safety in adolescents age 12 to 17 years (inclusive) during 52 weeks of treatment with Belviq XR 20 milligrams (mg)…
- Trial name
- NCT03338296
- Testing
- lorcaserin hydrochloride XR
- Where
- 16 sites in United States
- Volunteers
- 278 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Assess the Safety and Tolerability of E2511 in Healthy Participants
The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of E2511 following single ascending oral doses in healthy adult and elderly participants.
- Trial name
- NCT04547361
- Testing
- E2511
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Insomnia Disorders
A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users
The primary purpose of this study is to evaluate the abuse potential of lemborexant (E2006) in comparison to placebo and 2 controls with known abuse potential (ie, zolpidem and suvorexant) with similar indications (zolpidem and…
- Trial name
- NCT03158025
- Testing
- Zolpidem tablets, Suvorexant tablets, over-encapsulated, Lemborexant tablets
- Where
- Canada
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Hepatic Impairment
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
This study will be conducted to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of lemborexant after a single-dose administration.
- Trial name
- NCT03440424
- Testing
- Lemborexant
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Renal Impairment
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment
This study will be conducted to assess the effect of severe renal impairment on the pharmacokinetics of lemborexant after a single-dose administration.
- Trial name
- NCT03443063
- Testing
- Lemborexant
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Obstructive Sleep Apnea, Healthy Subjects
Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
This study will be conducted to determine whether lemborexant as compared to placebo decreases the peripheral oxygen saturation during total sleep time in healthy adult and elderly participants after a single dose of treatment…
- Trial name
- NCT03471871
- Testing
- Lemborexant 10 mg, Lemborexant 25 mg
- Where
- 11 sites in United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.