Topics

A Study to Assess the Drug Absorption Into the Blood After Administration of 3 Doses of AZD5718

2019-09-18 03:27:52 | BioPortfolio

Summary

This study will be conducted to evaluate the AZD5718 pharmacokinetic (PK) doses in order to determine exposure in a new dose range and compare with previous results. This study will include 14 subjects in a single site in United Kingdom. Each subject will be involved in the study for 6 to 7 weeks.

Description

This study will be an open-label, randomized, 3-period, 3-treatment, crossover study performed in healthy subjects at a single study center.

A total of 14 healthy male and female subjects (of no childbearing potential) will be randomized to ensure that at least 12 subjects are evaluable. Each subject will receive 3 different treatments at least 4 days apart and will be dosed following an overnight fast of at least 10 hours. The following treatments will be given:

- Treatment A: AZD5718 Dose A tablet

- Treatment B: AZD5718 Dose B tablet

- Treatment C: AZD5718 Dose C tablet

The study will comprise:

- A Screening Period of maximum 28 days.

- Three Treatment Periods during which subjects will be resident from the day before first dosing with AZD5718 (Day -1) in Treatment Period 1 until at least 48 hours after last dosing with AZD5718 in Treatment Period 3 for collection of PK and safety samples. Subjects will be discharged on Day 3 of Treatment Period 3.

- A Follow up Visit, 5 to 7 days after the last dose of investigational medicinal product (IMP).

There will be a minimum washout period of 4 days between each dose administration.

Each subject will be involved in the study for 6 to 7 weeks. This study will be conducted in male and female subjects aged 18 to 55 years.

Study Design

Conditions

Coronary Artery Disease

Intervention

Treatment A, Treatment B, Treatment C

Location

Research Site
London
United Kingdom
HA1 3UJ

Status

Not yet recruiting

Source

AstraZeneca

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-18T03:27:52-0400

Clinical Trials [12040 Associated Clinical Trials listed on BioPortfolio]

A Single Center Clinical Evaluation of Same Sitting Hybrid Revascularization: Robotic Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention for the Treatment of Coronary Artery Disease

The primary objective of this study is to assess the safety and effectiveness of same sitting, simultaneous hybrid robotic assisted coronary artery bypass grafting (CABG) and percutaneous ...

Comparison of One-stop Hybrid Revascularization Versus Percutaneous Coronary Intervention for the Treatment of Multi-vessel Disease

The "one-stop" hybrid coronary revascularization combines minimally invasive direct coronary artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced opera...

Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease

To demonstrate the safety and efficacy of the Cobra Cobalt Super Alloy Balloon-Expandable Coronary Stent System for the treatment of de novo and restenotic (previously unstented) lesions i...

Clinical Study to Evaluate the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease

Prospective, non-randomized, multi-center study assessing the long term safety and efficacy of the self expandable sirolimus eluting Xposition S stent in the treatment of unprotected left ...

Risk Factors of Individuals With Coronary Artery Disease

It would be useful to study coronary arteriovenous difference of various markers in patients who are undergoing coronary angiography for suspected coronary artery disease. Environmental an...

PubMed Articles [42303 Associated PubMed Articles listed on BioPortfolio]

Challenging surgery of giant right coronary aneurysm associated with coronary sinus fistula.

Coronary artery fistula is a rare congenital or acquired anomaly. It involves an abnormal connection between the coronary artery and the cardiac chambers or the large thoracic vessels. In some cases, ...

Safety and Efficacy of Antithrombotic Strategies in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: A Network Meta-analysis of Randomized Controlled Trials.

The antithrombotic treatment of patients with atrial fibrillation (AF) and coronary artery disease, in particular with acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI), po...

Anti-inflammatory and antioxidative effects of Dan-Lou tablets in the treatment of coronary heart disease revealed by metabolomics integrated with molecular mechanism studies.

The Dan-Lou tablet (DLT), a well-known Chinese prescription, has definitive clinical efficacy in the treatment of precordial discomfort and pain caused by coronary heart disease (CHD). However, the ph...

Efficacy and Safety of Antiplatelet Therapy Plus Xa Factor Inhibitors in Patients with Coronary Heart Disease: A Meta-Analysis.

BACKGROUND The aim of this study was to systematically evaluate the effect of oral Xa inhibitors plus antiplatelet therapy in the treatment of coronary artery disease. MATERIAL AND METHODS All randomi...

Coronary artery disease in adults with tetralogy of Fallot.

There are limited data about outcomes of coronary artery disease (CAD) in adults with repaired tetralogy of Fallot (TOF). The purpose of this study was to describe the prevalence and treatment of CAD ...

Medical and Biotech [MESH] Definitions

Surgical therapy of ischemic coronary artery disease achieved by grafting a section of saphenous vein, internal mammary artery, or other substitute between the aorta and the obstructed coronary artery distal to the obstructive lesion.

Use of a balloon catheter for dilatation of an occluded artery. It is used in treatment of arterial occlusive diseases, including renal artery stenosis and arterial occlusions in the leg. For the specific technique of balloon dilatation in coronary arteries, ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY is available.

Direct myocardial revascularization in which the internal mammary artery is anastomosed to the right coronary artery, circumflex artery, or anterior descending coronary artery. The internal mammary artery is the most frequent choice, especially for a single graft, for coronary artery bypass surgery.

Procedures, surgery, or other treatment without consent of person or persons receiving treatment.

Withholding or withdrawal of a particular treatment or treatments, often (but not necessarily) life-prolonging treatment, from a patient or from a research subject as part of a research protocol. The concept is differentiated from REFUSAL TO TREAT, where the emphasis is on the health professional's or health facility's refusal to treat a patient or group of patients when the patient or the patient's representative requests treatment. Withholding of life-prolonging treatment is usually indexed only with EUTHANASIA, PASSIVE, unless the distinction between withholding and withdrawing treatment, or the issue of withholding palliative rather than curative treatment, is discussed.

More From BioPortfolio on "A Study to Assess the Drug Absorption Into the Blood After Administration of 3 Doses of AZD5718"

Quick Search

Relevant Topic

AstraZeneca
AstraZeneca is ranked 6th in the world, based on a pharmaceutical annual sales, which were valued at $32,800 million in 2009.  it is a global company, working in more than 100 countries, and employing 62,000 people, around a sixth of which are dedic...


Searches Linking to this Trial