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NCT ID: NCT03080987 Completed - Healthy Clinical Trials

A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Participants

Start date: June 27, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 and 2.

NCT ID: NCT03078036 Completed - Breast Cancer Clinical Trials

International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study

BREAKOUT
Start date: March 13, 2017
Phase:
Study type: Observational

BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have started 1st line systemic cytotoxic chemotherapy. The study will estimate the prevalence of germline breast cancer susceptibility gene in an otherwise unselected population, describe the treatments administered and estimate the associated clinical outcomes of overall survival and progression-free survival amongst mutation carriers within the context of a low poly ADP ribose polymerase inhibitor treatment setting. Other exploratory analyses may be undertaken to describe somatic breast cancer susceptibility gene and other homologous recombination repair gene mutations.

NCT ID: NCT03075644 Completed - Clinical trials for Adult Growth Hormone Deficiency

A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Start date: March 3, 2017
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese adults with growth hormone deficiency.

NCT ID: NCT03074058 Completed - Clinical trials for Clinical Pharmacology

Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet

Start date: June 10, 2015
Phase: Phase 1
Study type: Interventional

The primary objective of this study was to establish the bioequivalence of two different tablet formulations containing BAY77-1931. The secondary objectives of this study were to assess the safety and tolerability, as well as to Investigate the plasma lanthanum concentration after BAY 77-1931 ODT 500 mg administration.

NCT ID: NCT03072238 Completed - Clinical trials for Metastatic Prostate Cancer

Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer

IPATential150
Start date: June 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).

NCT ID: NCT03071757 Completed - Clinical trials for Advanced Solid Tumors Cancer

A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors

Start date: March 21, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer [TNBC] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.

NCT ID: NCT03071133 Completed - Hepatitis C Clinical Trials

Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy

Start date: January 1, 2018
Phase:
Study type: Observational

An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan

NCT ID: NCT03070990 Completed - Clinical trials for Metastatic Urothelial Cancer

A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

Start date: April 24, 2017
Phase: Phase 1
Study type: Interventional

The objective of this study is to assess the safety, tolerability and pharmacokinetics of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma. This study will also assess the immunogenicity as defined by the incidence of anti-drug antibody (ADA) and anti-tumor activity of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma.

NCT ID: NCT03070587 Completed - Clinical trials for Social Anxiety Disorder

A Pilot Study of Loving-Kindness Meditation for Social Anxiety Disorder

Start date: December 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and test a mindfulness and loving-kindness based intervention, Positive Affect Training (PAT), to enhance positive affect such as compassion, love, and gratitude and reduce symptoms of social anxiety disorder (SAD). PAT involves a combination of practicing mindfulness meditation and loving kindness meditation in groups. Although PAT has been shown to be effective for dysthymic disorder, one area that remains unclear is whether the PAT protocol for SAD can address the social anxiety symptoms in Japanese adults with SAD. The goal of the research is to test the initial feasibility and efficacy in increasing positive affect and decreasing negative affect in individuals recruited from the general community who are social anxious. If PAT is also effective for Japanese SAD patients, it could be more cost-effective and noninvasive option to address social anxiety disorder.

NCT ID: NCT03070171 Completed - Healthy Clinical Trials

Bioequivalence of Tablet Formulation of Dabigatran Etexilate Compared to Commercial Capsule Formulation Following Oral Administration in Healthy Male Subjects

Start date: March 21, 2017
Phase: Phase 1
Study type: Interventional

The primary objective of this trial is to establish the bioequivalence of tablet formulation of dabigatran etexilate compared to commercial capsule formulation following oral administration under fasted condition. The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments.