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NCT ID: NCT03804645 Completed - Heart Failure Clinical Trials

A Study to Assess the Reaction of Body for Four Different Formulations of AZD9977 (Part A) and Influence of Food and Lower Dose of a Selected Formulation (Part B) in Healthy Male Subjects

Start date: February 5, 2019
Phase: Phase 1
Study type: Interventional

AZD9977 is an oral, selective mineralocorticoid receptor (MR) modulator. AZD9977 is a partial antagonist and partial agonist in reporter gene assays and has a different interaction pattern with the MR compared to eplerenone. This study will assess the pharmacokinetics (PK) of four different Formulations of AZD9977 (Part A) and influence of food and lower dose of a selected formulation (Part B) in healthy male subjects.

NCT ID: NCT03804567 Completed - Pain, Chronic Clinical Trials

Oldpain2go®: an Exploratory (Pre-Feasibility) Study.

Oldpain2go®
Start date: January 16, 2019
Phase: N/A
Study type: Interventional

Research question: Is there any evidence to suggest that the oldpain2go® intervention merits scientific investigation?

NCT ID: NCT03803319 Completed - Clinical trials for Irritable Bowel Syndrome

Effects of Dietary Fibre in Irritable Bowel Syndrome (IBS)

Start date: January 2, 2019
Phase: N/A
Study type: Interventional

The aim of the study is to investigate how different dietary fibre combinations affects physiological and microbiological outcomes, in addition to symptoms in those with IBS. The study will also explore the differences in responses between different fibres in different sub-types of IBS (e.g. constipation-predominant, diarrhoea-predominant and mixed).

NCT ID: NCT03802487 Completed - Clinical trials for Type 2 Diabetes Mellitus

Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects

Start date: January 14, 2019
Phase: Phase 1
Study type: Interventional

Primary Objective: To assess the absolute bioavailability of sotagliflozin via administration of an intravenous (IV) microdose of a 14C-sotagliflozin tracer on top of a single oral dose of unlabeled sotagliflozin without charcoal administration Secondary Objectives: - To assess the PK of sotagliflozin and its main metabolite sotagliflozin-3-O-glucuronide (M19) after a single oral dose of sotagliflozin and an IV microdose of a 14C-sotagliflozin tracer without charcoal administration - To assess the safety and tolerability of single doses of sotagliflozin when administered with and without charcoal

NCT ID: NCT03802292 Completed - Healthy Volunteers Clinical Trials

First-In-Man, Healthy Volunteer Study to Evaluate Safety on the Use of YQ23

Start date: January 16, 2019
Phase: Phase 1
Study type: Interventional

This study is to test the safety, tolerability, pharmacokinetics (PK-the amount of study drug in the blood), and immunogenicity (how the study drug affects the immune system) of single dose and dose levels of an investigational drug called YQ23.

NCT ID: NCT03802201 Completed - ß-thalassemia Clinical Trials

Study of PTG-300 in Non-Transfusion Dependent and Transfusion-Dependent Beta-Thalassemia Subjects With Chronic Anemia

TRANSCEND
Start date: December 19, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2 open-label, single-arm design study with dose escalation by subject cohort . The study is designed to monitor the PTG-300 safety profile, to obtain preliminary evidence of efficacy of PTG-300 for the treatment in β-thalassemia.

NCT ID: NCT03801967 Completed - Heart Failure Clinical Trials

A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 in Japanese Healthy Participants With Single and Multiple Ascending Dose Administration

Start date: January 24, 2019
Phase: Phase 1
Study type: Interventional

AZD9977 is an oral, selective mineralocorticoid receptor (MR) modulator. AZD9977 is a partial antagonist and partial agonist in reporter gene assays and has a different interaction pattern with the MR compared to eplerenone. This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD9977, following oral administration of single and multiple ascending dose of AZD9977.

NCT ID: NCT03800836 Completed - Breast Cancer Clinical Trials

A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Start date: February 13, 2018
Phase: Phase 1
Study type: Interventional

This is a study consisting of four cohorts in this setting. In Cohort 1, the safety and efficacy of ipatasertib (ipat) in combination with atezolizumab (atezo) and paclitaxel (pac) or nab-paclitaxel will be evaluated for participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not previously received chemotherapy. In Cohort 2, ipatasertib and atezolizumab (with no chemotherapy), will be administered to participants with locally advanced or metastatic TNBC. In Cohort 3, the safety and efficacy of neoadjuvant ipatasertib, atezolizumab, doxorubicin and cyclophosphamide (AC) (Ipat + Atezo + AC) followed by Ipat + Atezo + Pac will be evaluated in participants with locally advanced Type 2-4 (T2-4) TNBC. In Cohort 4, the safety and efficacy of Ipat + Atezo + Pac will be evaluated in participants with PD-L1 (Programmed Death-Ligand-1) positive locally advanced or metastatic TNBC that is not amenable to resection and who have not previously received chemotherapy in the advanced setting.

NCT ID: NCT03799367 Completed - Breast Feeding Clinical Trials

The Feasibility of Drug Delivery to Infants During Breastfeeding

FEDD
Start date: July 9, 2018
Phase: N/A
Study type: Interventional

Parents commonly find giving medicines to babies, using oral syringes or spoons, difficult and emotionally stressful. In developing countries, additional stress arises due to hygiene difficulties and the lack of clean water. To overcome these challenges and encourage breastfeeding, we have developed the concept of a Therapeutic Nipple Shield, a delivery system that makes it possible to give medicine and nutrients to babies during breastfeeding. It consists of a silicone nipple shield that allows the release of medicine/nutrients into human milk during the feed. Presentations of a prototype to parents and staff at the Rosie Hospital was very positive, and encouraged this clinical study. This study aims to give a vitamin B12 supplement to babies during breastfeeding. The supplement will be placed into a nipple shield, both of which are commercially available, and the mother will breastfeed her baby as usual. Before and after the feed, we will 1) collect a small blood sample from the baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to participate in two short interviews about her expectations and experiences using the Therapeutic Nipple Shield.

NCT ID: NCT03798756 Completed - Primary Care Clinical Trials

Automated Check-in Data Collection Study

ACDC
Start date: January 14, 2019
Phase:
Study type: Observational

The aim of this study is to examine patient acceptability, for providing brief research information, whilst self-completing an automated check-in screen prior to any general practice consultation.