Clinical trials: Japanese
Pulmonary Disease, Chronic Obstructive
Long-term Safety Study for GSK573719/GW642444 in Japanese
The objective of this study is to evaluate the safety and tolerability of GSK573719/GW642444 Inhalation Powder 125/25 mcg once-daily.
- Trial name
- DB2115362 (NCT01376388)
- Testing
- GSK573719/GW642444 Inhalation Powder
- Where
- 23 sites in Japan
- Volunteers
- 131 people
- Sponsor
- GlaxoSmithKline
Neoplasms
A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients
The primary objective of this study is to determine the dose of aflibercept to be further studied in combination with docetaxel in Japanese cancer patients.
- Trial name
- NCT00545246
- Testing
- aflibercept (AVE0005), docetaxel
- Where
- 2 sites in Japan
- Volunteers
- 12 people
- Sponsor
- Sanofi
Advanced Solid Tumor, Metastatic Triple-Negative Breast Cancer
Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors
The primary objectives of this study are as follows: Phase 1 (sequential dose-escalation): to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent and to determine the recommended Phase 2 dose…
- Conditions
- Advanced Solid Tumor, Metastatic Triple-Negative Breast Cancer, HR+/HER2- Metastatic Breast Cancer, Metastatic Urothelial Cancer
- Trial name
- ASCENT-J02 (NCT05101096)
- Testing
- Sacituzumab Govitecan-hziy
- Where
- 36 sites in Japan
- Volunteers
- 135 people
- Sponsor
- Gilead Sciences
Hepatitis C
Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the safety and efficacy of SOF administered in…
- Trial name
- NCT02562742
- Testing
- SOF, REB
- Where
- 45 sites in Japan
- Volunteers
- 554 people
- Sponsor
- Gilead Sciences
Biallelic RPE65 Mutation-associated Retinal Dystrophy
Study of Efficacy and Safety of Voretigene Neparvovec in Japanese Patients With Biallelic RPE65 Mutation-associated Retinal Dystrophy
The purpose of this study is to provide safety and efficacy data for voretigene neparvovec, administered as subretinal injection, in Japanese patients with biallelic RPE65 mutation-associated retinal dystrophy.
- Trial name
- NCT04516369
- Testing
- voretigene neparvovec
- Where
- Japan
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Malignancies
Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies
Part 2 Cohorts A and C This study is being conducted to test the safety and pharmacokinetics of cemiplimab in patients with lung cancer.
- Trial name
- NCT03233139
- Testing
- Cemiplimab, Ipilimumab, Platinum-doublet chemotherapy
- Where
- 20 sites in Japan
- Volunteers
- 146 people
- Sponsor
- Regeneron Pharmaceuticals
Healthy
A Safety, Tolerability and Pharmacokinetics Study of JNJ-54861911 in Healthy Japanese Male Participants
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK, study of the way a drug enters and leaves the blood and tissues over time) of single-ascending oral doses of JNJ-54861911 in healthy…
- Trial name
- NCT02180269
- Testing
- JNJ-54861911 (25 mg), JNJ-54861911 (50 mg), JNJ-54861911 (100 mg)
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
Parkinson Disease
A Phase I Study of TRN501 in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TRN501 following a single administration of TRN501 or placebo to healthy adult male volunteers.
- Trial name
- NCT06453551
- Testing
- TRN501 - Dose 1, TRN501 - Dose 2, TRN501 - Dose 3
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- SNLD, Ltd.
Hepatitis C Infection
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients
The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in…
- Trial name
- NCT01016912
- Testing
- BMS-790052, Peginterferon alfa-2b, Ribavirin
- Where
- 6 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Bristol-Myers Squibb
Dermatitis, Atopic
A Study of JNJ-39758979 in Adult Japanese Patients With Moderate Atopic Dermatitis
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-39758979 in adult Japanese patients with moderate, active atopic dermatitis.
- Trial name
- NCT01497119
- Testing
- JNJ-39758979, 300 mg, JNJ-39758979, 100 mg
- Where
- 13 sites in Japan
- Volunteers
- 88 people
- Sponsor
- Janssen Pharmaceutical K.K.
Atrial Fibrillation
Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan
The primary objective of this study is to compare the Length of Stay from treatment of oral anticoagulant initiation to hospital discharge of patients hospitalized and subsequently treated with dabigatran or warfarin for…
- Trial name
- NCT02631057
- Testing
- Dabigatran, Warfarin
- Where
- 2 sites in Japan
- Volunteers
- 4,313 people
- Sponsor
- Boehringer Ingelheim
Non-erosive Reflux Disease
Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population
The purpose of this study is to study safety and efficacy of omeprazole standard treatment in a Japanese non-erosive reflux disease population.
- Trial name
- NCT00259077
- Testing
- Omeprazole
- Where
- 26 sites in Japan
- Volunteers
- 270 people
- Sponsor
- AstraZeneca
Growth Hormone Deficiency
A Long-Term Safety Study of Somavaratan in Japanese Children With Growth Hormone Deficiency
This study is a multi-center, open-label safety study assessing long-term somavaratan administration.
- Trial name
- NCT03145831
- Testing
- Somavaratan
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Versartis Inc.
Heart Failure With Preserved Ejection Fraction (HFpEF)
A Study to Assess the Effect AZD4831 in Japanese and Chinese Healthy Volunteers
This study is randomized, single-blind, placebo-controlled Phase 1 study aimed to assess the safety and efficacy, pharmacokinetics and pharmacodynamics of multiple doses of oral AZD4831 in healthy Japanese and Chinese volunteers
- Trial name
- NCT04232345
- Testing
- AZD4831
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male Participants
The purpose of this study is to evaluate the PK, safety and tolerability of phenylacetate and benzoate after intravenous administration of TAK-123 in Japanese healthy adult male participants.
- Trial name
- NCT04155567
- Testing
- TAK-123
- Where
- Japan
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Takeda
Multiple Myeloma
Plerixafor Plus Granulocyte Colony-stimulating Factor (G-CSF) For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Multiple Myeloma
Primary Objective: To determine if Multi Myeloma (MM) patients mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 6 x 10^6…
- Trial name
- NCT02221479
- Testing
- plerixafor GZ316455, Filgrastim
- Where
- 5 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Genzyme, a Sanofi Company
Rheumatoid Arthritis
Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
The purpose of this study is to evaluate the long-term safety of subcutaneous (SC) self-injections (by the subject or subject's family member) of adalimumab in adult Japanese subjects with Rheumatoid Arthritis in an open-label…
- Trial name
- NCT00603993
- Testing
- Adalimumab
- Where
- 16 sites in Japan
- Volunteers
- 88 people
- Sponsor
- Abbott
Health Participants
A Study to Assess Safety, Tolerability and Pharmacokinetics of Transdermal SFG-02 in Healthy Participants
This Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of a novel transdermal formulation of SFG-02 following single and repeated applications in Japanese and White healthy adult participants.
- Trial name
- NCT07167914
- Testing
- SFG-02
- Where
- Japan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Juro Sciences Inc.
Healthy Subjects
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group 1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP), Group 2: 7-valent…
- Trial name
- NCT01200368
- Testing
- 13-valent pneumococcal conjugate vaccine (13vPnC), diphtheria, tetanus, and acellular pertussis vaccine (DTaP), 7-valent pneumococcal conjugate vaccine (7vPnC)
- Where
- 32 sites in Japan
- Volunteers
- 551 people
- Sponsor
- Pfizer
Chronic Cough
Study of Gefapixant (MK-7264) in Adult Japanese Participants With Unexplained or Refractory Chronic Cough (MK-7264-033)
This estimation study (no hypotheses) will evaluate the safety, tolerability, and efficacy of gefapixant (MK-7264) in Japanese adult participants with unexplained or refractory chronic cough.
- Trial name
- NCT03482713
- Testing
- Gefapixant 45 mg
- Where
- 16 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Merck Sharp & Dohme LLC
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