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Multiple Dose Safety Study of SRX246 Capsules in Healthy Volunteers

2014-08-27 03:15:09 | BioPortfolio

Summary

This is a multiple dose clinical study to be conducted with SRX246 capsules to determine the safety, tolerability and pharmacokinetics of the drug over a 14 day dosing period.

Description

This study is intended to evaluate the safety, tolerability and pharmacokinetic profile of multiple oral doses of SRX246 in healthy adult volunteers.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Conditions

Healthy

Intervention

SRX246

Location

SNBL Clinical Pharmacology Center
Baltimore
Maryland
United States
21201

Status

Recruiting

Source

Azevan Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:09-0400

Clinical Trials [8 Associated Clinical Trials listed on BioPortfolio]

Study of SRX246 Capsules in Healthy Adult Volunteers

This is the first study of SRX246 in humans, and is being conducted to begin to establish a safety profile of orally administered SRX246.

Tolerability, Safety, and Activity of SRX246 in Irritable Subjects With Huntington's Disease

This study evaluates the tolerability, safety and activity of SRX246 in the treatment of irritability in patients with Huntington's disease. Two-thirds of all participants will receive SR...

Effects of SRX246, a Vasopressin Receptor (V1a) Antagonist, on an Experimental Model of Fear and Anxiety in Humans

Background: Arginine vasopressin (AVP) is a hormone made in the body. It can make negative feelings stronger. The way AVP is regulated may be abnormal in people who have mood and anxiety ...

Healthy Together Program Evaluation (Phase 3)

Healthy Together is a program that promotes the achievement and maintenance of healthy weights in children and their families.

Healthy for Two, Healthy for You

Investigators conducted a pilot feasibility and acceptability randomized controlled trial of a remotely delivered behavioral health coaching program in pregnancy and postpartum.

PubMed Articles [4462 Associated PubMed Articles listed on BioPortfolio]

Defining and Estimating Healthy Aging in Spain: A Cross-sectional Study.

Using an operational continuum of healthy aging developed by U.S. researchers, we sought to estimate the prevalence of healthy aging among older Spaniards, inform the development of a definition of he...

Peace, Love, Field Day: An Innovative Approach to Cultivating Healthy Academic Communities.

The American Nurses Association declared 2017 the Year of the Healthy Nurse. In an effort to promote a healthy academic environment, faculty and staff in institutions of higher learning should serve a...

Ontario's Healthy Babies Healthy Children Screen tool: identifying postpartum families in need of home visiting services in Ottawa, Canada.

Across Ontario, the Healthy Babies Healthy Children (HBHC) postpartum screening tool is routinely used to identify families with potential risk of negative development outcomes for children.

Increased practice of a standing motor sequence task in healthy young and healthy elders: Short communication.

Sequence-specific learning (SSL); the ability to implicitly integrate repeated sequences compared to random sequences during a motor sequence paradigm, is impaired in healthy elders (HE) compared to h...

Domains and Measurements of Healthy Aging in Epidemiological Studies: A Review.

Few studies have recommended the essential domains of healthy aging and their relevant measurement to assess healthy aging comprehensively. This review is to fill the gap, by conducting a literature r...

Medical and Biotech [MESH] Definitions

Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.

Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.

Surgical reinnervation of a denervated peripheral target using a healthy donor nerve and/or its proximal stump. The direct connection is usually made to a healthy postlesional distal portion of a non-functioning nerve or implanted directly into denervated muscle or insensitive skin. Nerve sprouts will grow from the transferred nerve into the denervated elements and establish contact between them and the neurons that formerly controlled another area.

Process of evaluating the health of a patient and determining if they are healthy enough for surgery.

Dietary patterns which have been found to be important in reducing disease risk.

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