Advertisement

Topics

Study to Assess Cardiac Conduction of GSK1349572

2014-08-27 03:18:39 | BioPortfolio

Summary

This will be a randomized, partial-blind, placebo-controlled, single dose, cross-over trial investigating the effect of GSK1349572 on cardiac repolarization as compared to placebo in healthy adult males and females. Approximately 42 subjects will be enrolled in this study and will be admitted to the clinic for three separate dosing sessions. Subjects will receive single dose administrations of placebo, a supratherapeutic dose of GSK1349572 (250 mg), and moxifloxacin (400 mg) in random sequence. Safety of subjects will be monitored by clinical observation, measures of vital signs, 12-lead ECGs and clinical laboratory measurements.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Conditions

Healthy Subjects

Intervention

GSK1349572 250 mg, Placebo Suspension, Moxifloxacin 400 mg

Location

GSK Investigational Site
Baltimore
Maryland
United States
21225

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:39-0400

Clinical Trials [2954 Associated Clinical Trials listed on BioPortfolio]

GSK1349572 First Time in Human Study

To determine safety, tolerability and pharmacokinetics of GSK1349572

GSK1349572 Drug Interaction Study With Efavirenz

GSK1349572 is an integrase inhibitor that is currently in Phase 2 clinical trials for the treatment of HIV infection. As GSK1349572 development progresses, it may be dosed with non-nucleo...

GSK1349572 Drug Interaction Study With Protease Inhibitors

A study in healthy volunteers to determine whether there is a drug interaction between GSK1349572 and the HIV protease inhibitors lopinavir/ritonavir and darunavir/ritonavir

GSK1349572 Proton Pump Inhibitor Drug Interaction and Supratherapeutic Dose Study

GSK1349572 is an integrase inhibitor that is currently being evaluated for the treatment of HIV infection. The primary objective of this study is to determine whether the addition of a pr...

GSK1349572 Drug Interaction Study With Etravirine

A study in healthy volunteers to determine whether there is a drug interaction between GSK1349572 and etravirine

PubMed Articles [7790 Associated PubMed Articles listed on BioPortfolio]

Effects of moxifloxacin on the proarrhythmic surrogate markers in healthy Filipino subjects: Exposure-response modeling using ECG data of thorough QT/QTc study.

Effects of moxifloxacin on QTc as well as proarrhythmic surrogate markers including J-Tc, T-Tand short-term variability (STV) of repolarization were examined by using both standard E14 time-based eval...

A Thorough QT Study to Evaluate the Effects of Supratherapeutic Doses of Ledipasvir on the QTc Interval in Healthy Subjects.

This study evaluated the effect of supratherapeutic exposure of the anti-HCV drug ledipasvir on the QTc interval in healthy subjects. Sixty healthy volunteers were randomized to receive twice-daily bl...

A Phase 1, Randomized, Placebo- and Active-Controlled Crossover Study to Determine the Effect of Single-Dose Ertugliflozin on QTc Interval in Healthy Volunteers.

Ertugliflozin, a selective sodium-glucose cotransporter-2 inhibitor, is being developed for the treatment of type 2 diabetes mellitus. This randomized, 6-sequence, 3-period crossover study assessed th...

Impact of the Norepinephrine Prodrug Droxidopa on the QTc Interval in Healthy Individuals.

A double-blind, 4-period crossover study (NCT01327066) was conducted to assess the effect of the novel norepinephrine prodrug droxidopa on the QT interval in in healthy subjects. Subjects were randomi...

Pharmacokinetics of Tildrakizumab (MK-3222), an Anti-IL-23 Monoclonal Antibody, Following Intravenous or Subcutaneous Administration in Healthy Subjects.

Tildrakizumab, a high-affinity humanized IgG1k antibody that selectively binds interleukin (IL)-23 p19 subunit of cytokine IL-23 and neutralizes its function, is under investigation for treatment of m...

Medical and Biotech [MESH] Definitions

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

Negative test results in subjects who possess the attribute for which the test is conducted. The labeling of diseased persons as healthy when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)

Positive test results in subjects who do not possess the attribute for which the test is conducted. The labeling of healthy persons as diseased when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)

Books intended for use in the study of specific subjects, containing systematic presentation of the principles and essential knowledge of the subjects.

A type of analysis in which subjects in a study group and a comparison group are made comparable with respect to extraneous factors by individually pairing study subjects with the comparison group subjects (e.g., age-matched controls).

More From BioPortfolio on "Study to Assess Cardiac Conduction of GSK1349572"

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...

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...


Searches Linking to this Trial