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NCT ID: NCT04504760 Completed - Healthy Volunteers Clinical Trials

Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects

Start date: July 10, 2020
Phase: Phase 1
Study type: Interventional

To investigate safety, tolerability and pharmacokinetics in Japanese and Caucasian subjects when ONO-2910 is administered as single and multiple doses orally.

NCT ID: NCT04503863 Completed - Clinical trials for Safety and Pharmacokinetics

An Additional Study of NPC-22 in Healthy Adult Males

Start date: July 20, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to examine the safety and pharmacokinetics of high dose NPC-22 administration in healthy adult males. The effect of administration routes for pharmacokinetics will be examined in advance.

NCT ID: NCT04501497 Completed - Clinical trials for Non-small Cell Lung Cancer

Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)

Start date: August 21, 2020
Phase:
Study type: Observational

This is a multi-center observational study of atezolizumab combination therapy in patients with unresectable, advanced and recurrent non-small cell lung cancer(NSCLC) or extensive disease small cell lung cancer(ED-SCLC). 800 patients in NSCLC cohort and 400 patients in ED-SCLC cohort will be enrolled in this trial to assess the efficacy and safety of this combination.

NCT ID: NCT04500808 Completed - Healthy Clinical Trials

A Study of Macitentan, in Healthy Japanese Male Participants

Start date: July 21, 2020
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety and tolerability after multiple-dose administrations of macitentan with titration regimen starting from Dose 1 once daily (qd) up to Dose 2 qd in Japanese healthy adult male participants (Part 1) and to evaluate the effect of food on pharmacokinetics of macitentan and its active metabolite (ACT-132577) in Japanese healthy adult male participants with macitentan Dose 3 tablet (Part 2).

NCT ID: NCT04499248 Recruiting - Ocular Hypertension Clinical Trials

AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension

Start date: November 16, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-groups (Cohort 2) and (Cohort 3) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension

NCT ID: NCT04498832 Completed - Healthy Volunteers Clinical Trials

Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Japanese Adults 60 Years of Age and Older

Start date: October 21, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination inhibition [HAI] geometric mean titers [GMTs] and seroconversion rates) that was superior to responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all participants. Secondary Objective: - To describe the immune response induced by QIV-HD and QIV-SD by HAI measurement method in all participants. - To describe the safety profile of all participants in each study group.

NCT ID: NCT04498403 Terminated - Atopic Dermatitis Clinical Trials

A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis

Start date: September 14, 2020
Phase: Phase 3
Study type: Interventional

This study is a Phase 3, multicenter, open-label, long-term safety extension study of Studies C3291032 and C3291031 in Japanese pediatric and adult participants with mild to moderate Atopic Dermatitis (AD).

NCT ID: NCT04496089 Completed - Clinical trials for Carcinoma, Renal Cell

Evaluation of Safety, Biodistibution and Sensitivity/Specificity of PET/CT Imaging With 89Zr-TLX250 in Subjects With RCC

ZIRDAC-JP
Start date: August 1, 2020
Phase: Phase 1
Study type: Interventional

89Zr-TLX250 is a carbonic anydrase IX (CAIX)-targeted imaging agent that is under clinical development as a non-invasive diagnostic imaging agent for teh detection of clear cell renal cell carcinoma (ccRCC). The Phase 1 study part of this study is to confirm the safety/tolerability and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with suspected renal cell carcinoma (RCC) including clear cell renal cell carcinoma. The Phase 2 component of the study is to to evaluate the sensitivity/specificity of using 89Zr-TLX250 PET/CT images to detect RCC and ccRCC in patients with suspected RCC.

NCT ID: NCT04495127 Completed - Clinical trials for Neurofibromatosis Type 1

Selumetinib Paediatric NF1 Japan Study

Start date: August 31, 2020
Phase: Phase 1
Study type: Interventional

This is a phase I open label study designed to evaluate the safety, tolerability, PK and efficacy of selumetinib in Japanese paediatric patients with neurofibromatosis type 1 and inoperable and symptomatic plexiform neurofibroma.

NCT ID: NCT04494425 Active, not recruiting - Clinical trials for Advanced or Metastatic Breast Cancer

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

DB-06
Start date: July 24, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.