Advertisement

Topics

Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers

2014-08-27 03:40:17 | BioPortfolio

Summary

The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers.

Description

This was a double-blind, placebo-controlled, dose-escalating, multiple-dose study of orally administered ST-246 to 30 healthy volunteers ages 18-50 years, randomized to receive either active drug (8 subjects) or placebo (2 subjects) in 1 of 3 dosing groups (250, 400 or 800mg groups). Each dose group of 10 was divided into two cohorts of 5 subjects (4 active and 1 placebo). The first cohort was dosed approximately 4-8 weeks before the second cohort of each dose group. Dose groups completed the study treatment approximately 5 weeks prior to the start of the following dose group. Study procedures included several overnight stays, medical history/exam, laboratory testing done by blood draw, and electrocardiograms.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Healthy

Intervention

ST-246, Placebo

Location

Orlando Clinical Research
Orlando
Florida
United States
32809

Status

Completed

Source

SIGA Technologies

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:40:17-0400

Clinical Trials [878 Associated Clinical Trials listed on BioPortfolio]

Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers.

A Study of RO6870868 in Healthy Volunteers

This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics of RO6870868 in healthy volunteers. Subjects will be randomized to receive ...

A Study of MCAF5352A in Healthy Volunteers

This single-center, randomized, placebo-controlled, double-blind, multiple ascen ding dose study will evaluate the safety, pharmacokinetics and immunogenicity of MCAF5352A in healthy volun...

Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males

The main purpose of this study is to assess the safety, tolerability, and biological activity of SD-101 compared with placebo in healthy male volunteers.

A Study of Single Dose RO6811135 in Healthy Volunteers

This randomized, double-blind, placebo-controlled study will evaluate the safety , tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in healthy vo lunteers. Subjects will b...

PubMed Articles [5210 Associated PubMed Articles listed on BioPortfolio]

Placebo analgesia persists during sleep: An experimental study.

Although placebo analgesia is a well-recognized phenomenon with important clinical implications, the possibility that placebo effects occur during sleep has received little attention. This experimenta...

Tramadol Hydrochloride at Steady State Lacks Clinically Relevant QTc Interval Increases in Healthy Adults.

We evaluated the effects of therapeutic and supratherapeutic doses of tramadol hydrochloride on the corrected QT (QTc) interval in healthy adults (aged 18-55 years) in a randomized, phase I, double-b...

Electrocardiographic effects of hawthorn (Crataegus oxyacantha) in healthy volunteers: A randomized controlled trial.

The objective of this study was to evaluate the electrocardiographic effects of hawthorn in healthy adult volunteers. It was double-blind cross-over trial randomized 20 healthy adult volunteers to rec...

The Opioid Receptor Mu 1 (OPRM1) rs1799971 and Catechol-O-methyltransferase (COMT) rs4680 as genetic markers for placebo analgesia.

The placebo effect is considered the core example of mind-body interactions. However, individual differences produce large placebo response variability in both healthy volunteers and patients. The pla...

Placebo Responses in Chronic Pain: State of Research and Clinical Implications.

Placebo hypoalgesia has been found to play an important role in every health care by modulating patients' responses to pharmacologically active analgesic treatments. It may be seen as reflecting the c...

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.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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.

More From BioPortfolio on "Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...


Searches Linking to this Trial