A Three-Part Study Of GSK580416 In Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Parts A and B of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to placebo. Part C of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of GSK580416 in healthy subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Escalating Doses of GSK1325756 Solution for Infusion, and Absolute Bioavailability Relative of an Oral Dose, in Healthy Adult Subjects

NCT02169583

Infections, Respiratory Tract

COMPLETED PHASE1

Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness

NCT05603143

COVID-19

TERMINATED PHASE3

First-in-Human Study of Orally Administered GS-441524 for COVID-19

NCT04859244

COVID-19

COMPLETED PHASE1

A Phase 2a Study to Evaluate Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus

NCT02673476

Respiratory Syncytial Virus Infections

COMPLETED PHASE2

To Evaluate Safety, Tolerability, Pharmacokinetics, And Food Effect Of Single Doses Of GSK945237 In Healthy Subjects

NCT00517673

Healthy Subjects Infections, Bacterial

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Tract Infection Infections, Bacterial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GSK580416

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy as determined by a physician
* Healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive)
* Body weight \> = 50 kg and BMI between 19 and 30 kg/m2 (inclusive)

Exclusion Criteria

* Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody with 3 months of screening
* Male and female subjects not willing to follow study specified contraceptive methods
* Subjects taking any recreational drugs
* Regular use of tobacco- or nicotine-containing products within 6 months prior to screening
* Has participated in a clinical trial and have not received a drug within 30 days before the dose of study drug
* Has exposed to more than 4 new chemical entities within 12 months before the first dosing day
* Use of prescription or over-the-counter medications within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
* Use of St. John's Wort within 28 days before the first dose of study drug
* Subjects not willing to follow study specified life style restrictions
* Blood donation in excess of 500 mL within a 56 days period

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes