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NCT ID: NCT03597217 Completed - Healthy Clinical Trials

A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults

Start date: August 27, 2018
Phase: Phase 1
Study type: Interventional

The current study is designed to evaluate the safety, tolerability and pharmacokinetics of PF-05221304 in healthy Japanese adult subjects following single and multiple dose administration.

NCT ID: NCT03596164 Completed - Clinical trials for Short Bowel Syndrome

An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004

Start date: July 9, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this clinical study is to evaluate the long-term safety and efficacy of teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent SBS (short bowel syndrome) who completed SHP633-306 or who were in the extension phase of the TED-C14-004 (NCT02340819) study.

NCT ID: NCT03595202 Completed - Clinical trials for Healthy Participants

Clinical Study of TS-143 in Healthy Adult Male Subjects (Multiple-Dose Administration)

Start date: April 3, 2017
Phase: Phase 1
Study type: Interventional

To investigate the safety, pharmacokinetics and pharmacodynamics of TS-143 when administered 3 times a day for 10 days to healthy Japanese adult males using placebo-controlled, double-blind, dose escalation study design.

NCT ID: NCT03591133 Completed - Clinical trials for Healthy Participants

Clinical Study of TS-143 in Healthy Adult Male Subjects (Single-Dose Administration)

Start date: December 24, 2015
Phase: Phase 1
Study type: Interventional

To investigate the safety, pharmacokinetics and pharmacodynamics when administering a single dose of TS-143 to Japanese healthy adult males using a placebo-controlled, double-blind, dose-ascending study, in addition to the effects of meals.

NCT ID: NCT03590938 Completed - Breast Cancer Clinical Trials

Lynparza Breast Cancer Clinical Experience Investigation

Start date: August 14, 2018
Phase:
Study type: Observational

To characterise the development of ADRs of bone marrow depression in patients under actual post-marketing use

NCT ID: NCT03590613 Completed - Autoimmune Diseases Clinical Trials

Phase I Study of GSK2982772 in Japanese Healthy Male Participants

Start date: July 19, 2018
Phase: Phase 1
Study type: Interventional

The study plans to enroll approximately 12 subjects. The main objective of the study is to assess the safety, tolerability and pharmacokinetics (PK) of the three times a day (TID), dosing of GSK2982772, in Japanese healthy male subjects. The study will comprise of four study periods each at least 7 days in duration with subjects in-house for 4 nights (through 72 hrs after the first dose). During each treatment period (TP), subjects will be admitted to the unit the day before dosing and will be discharged after completion of the 72 hours post-dose assessments. There will be a washout of atleast 7-days between the TP doses for each individual, post which there will be 7-days follow-up. The dose range proposed in this study is based on a low starting dose, which will be escalated to the highest dose that is intended for the Phase 2b dose range study. The decision to proceed to the next dose-level, of GSK2982772 within the study will be made by principal investigator and GSK Medical Monitor per each dosing periods. The study duration is approximately 22 weeks.

NCT ID: NCT03586973 Completed - Clinical trials for Advanced Hepatocellular Carcinoma

A Phase 2 Study of Cabozantinib in Japanese Participants With Advanced Hepatocellular Carcinoma

Start date: August 6, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of cabozantinib in Japanese participants with advanced hepatocellular carcinoma (HCC) who have received prior systemic anticancer therapy.

NCT ID: NCT03583697 Completed - Achondroplasia Clinical Trials

A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia

Start date: June 13, 2018
Phase: Phase 2
Study type: Interventional

Study 111-206 is a Phase 2 randomized, double-blind, placebo-controlled clinical trial of BMN 111 in infants and young children with a diagnosis of achondroplasia.

NCT ID: NCT03581071 Completed - Clinical trials for Chronic Kidney Disease

Clinical Pharmacology Study of TS-143 in Nondialysis and Hemodialysis Patients With Chronic Kidney Disease

Start date: October 6, 2016
Phase: Phase 1
Study type: Interventional

To evaluate the safety, pharmacokinetics, and pharmacodynamics in nondialysis (ND) and hemodialysis (HD) subjects with Chronic Kidney Disease (CKD) who receive a single administration of TS-143.

NCT ID: NCT03580356 Completed - Clinical trials for Chronic Spontaneous Urticaria

A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.

Start date: October 20, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study was to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,079 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines. This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.