Clinical trials: Healthy Japanese
Pneumococcal Infection
Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)
The purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAX™23 in healthy Japanese adults.
- Trial name
- NCT04665050
- Testing
- V116, PNEUMOVAX™23
- Where
- 2 sites in Japan
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Japanese Encephalitis
Immunogenicity Study of the Japanese Encephalitis Vaccine IC51
The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged > or = 18 years
- Trial name
- NCT00604708
- Testing
- IC51, JE-VAX
- Volunteers
- 867 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
Rabies, Japanese Encephalitis
Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects
Establish non-inferiority of the immune response and evaluate the safety and tolerability of Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to either of 2 schedules for preexposure…
- Trial name
- NCT01662440
- Testing
- Rabies, Japanese Encephalitis
- Where
- 3 sites in Austria, Germany and 1 more
- Volunteers
- 661 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Healthy
Single Rising Doses of BI 655064 in Healthy Chinese and Japanese Male Volunteers
Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising doses in healthy Asian male volunteers.
- Trial name
- NCT01917916
- Testing
- BI 655064
- Where
- 2 sites in Japan, South Korea
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese Participants
This is a randomized, double-blind (sponsor-open), placebo-controlled, single-center study involving Japanese participants. The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics…
- Trial name
- NCT04138043
- Testing
- GSK2330811
- Where
- United Kingdom
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Clinical Pharmacology
TAK-114 Single- and Multiple-Dose Phase 1 Study
The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese male participants.
- Trial name
- NCT02286518
- Testing
- TAK-114 10 mg capsule
- Where
- Japan
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Participants
Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants
The primary objective of this study is to evaluate the pharmacokinetics (PK) of AMG 133 after single subcutaneous (SC) administration in healthy Japanese and Caucasian participants.
- Trial name
- NCT05056246
- Testing
- AMG 133
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Amgen
Alzheimer's Disease
A Study of Florbetapir (18F) in Japanese Healthy Volunteers
This study will determine how florbetapir (18F) (18F-AV-45) radioactivity is distributed throughout the body of Japanese subjects.
- Trial name
- NCT01660815
- Testing
- florbetapir (18F)
- Where
- Japan
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Avid Radiopharmaceuticals
Bleeding
A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects
"This is a single-center, randomized, double-blind, and placebo-controlled trial designed to: 1) demonstrate the degree to which administered andexanet doses can reverse Factor Ten A (FXa)-inhibitor induced anticoagulation; and…
- Trial name
- NCT03310021
- Testing
- Andexanet alfa, Apixaban, Rivaroxaban
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Human Immunodeficiency Virus (HIV) Infection
Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851)
This study is designed to evaluate safety, tolerability, and pharmacokinetics of a single 1200-mg dose of raltegravir (MK-0518, ISENTRESS®) in healthy Japanese male participants.
- Trial name
- NCT03667547
- Testing
- Raltegravir
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Japanese Children Age 2 Years Through 6 Years
A Phase 3 Open-label Study to Evaluate the Safety of MEDI3250 in Healthy Japanese Children Age 2 Years Through 6 Years
This open-label, single arm, multicenter study will enroll approximately 100 subjects. The study is designed to gather the safety and tolerability data in Japanese children 2 to 6 years of age that would support approval of…
- Trial name
- NCT02269488
- Testing
- MEDI3250
- Where
- 3 sites in Japan
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Pneumococcal Infections
Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)
The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Conjugate Vaccine (PCV13).
- Trial name
- NCT04384107
- Testing
- V114, PCV13
- Where
- 45 sites in Japan
- Volunteers
- 694 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Japanese Children Age 7 Years Through 18 Years
A Phase3 Study to Evaluate the Efficacy and Safety of MEDI3250 in Healthy Japanese Children Age 7 Years Through 18 Years
The study is designed to gather the efficacy, safety and tolerability data in Japanese children 7 to 18 years of age that would support approval of MEDI3250 in Japan.
- Trial name
- NCT02269475
- Testing
- MEDI3250
- Where
- 38 sites in Japan
- Volunteers
- 1,369 people
- Sponsor
- AstraZeneca
Healthy Volunteer
Pharmacokinetics and Safety Study of Omecamtiv Mecarbil in Healthy Japanese Adults
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of omecamtiv mecarbil in healthy volunteers in Japan.
- Trial name
- NCT02601001
- Testing
- Omecamtiv mecarbil
- Where
- Japan
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Cytokinetics
Insomnia
A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)
The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.
- Trial name
- NCT01055834
- Testing
- Eszopiclone 3 mg, Eszopiclone 1 mg
- Where
- Japan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Japanese Premenopausal Healthy Adult Women
A Food Effect Study of TAK-385 Final Formulation
The purpose of this study is to evaluate food effects on the pharmacokinetics of a single oral dose of TAK-385 in Japanese premenopausal healthy adult women.
- Trial name
- NCT02792062
- Testing
- TAK-385 40 mg
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
PK Study of Xevinapant (Debio 1143) in Healthy East Asian Participants
The purpose of this study was to evaluate the pharmacokinetics (PK) of Xevinapant (Debio 1143) and its metabolite D-1143-MET1 as well as safety and tolerability of Xevinapant (Debio 1143) in healthy East Asian participants.
- Trial name
- NCT05519540
- Testing
- Xevinapant (Debio 1143)
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Japanese Encephalitis
Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects
The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity, reactogenicity, and safety data obtained with…
- Trial name
- NCT02492165
- Testing
- Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
- Where
- Vietnam
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Healthy
A Study in Healthy Japanese Men to Test How Different Doses of BI 1323495 Are Tolerated and How Itraconazole Influences the Amount of BI 1323495 in the Blood
The main objective of the single-rising dose (SRD) part and the multiple rising dose (MD) part is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics (for MD part only) following single rising doses and…
- Trial name
- NCT04619251
- Testing
- BI 1323495, Itraconazole
- Where
- Japan
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Inflammatory Diseases
Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
The primary objective of this study is to evaluate the pharmacokinetics (PK) of efavaleukin alfa after single subcutaneous (SC) administration in healthy Chinese, Japanese, and Caucasian participants.
- Trial name
- NCT04987333
- Testing
- Efavaleukin alfa
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amgen