Track topics on Twitter Track topics that are important to you
The purpose of this study is to evaluate the safety and tolerability of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.
The drug being tested in this study is called TAK-828. TAK-828 is being tested to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.
The study will enroll approximately 36 healthy participants. An interleaving crossover design with placebo substitution will be used for Cohorts 1-3. Each cohort will consist of 12 participants, randomly assigned (by chance, like flipping a coin) to a treatment sequence to receive TAK-828 or placebo after undergoing a fasting stage of at least 8 hours through intervention periods 1-4 for Cohorts 1 and 2 and through intervention periods 1 - 3 for Cohort 3. The assigned treatment sequence will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). An additional interventional period 5 (fed state) is planned to be conducted in either cohort 1 or 2, based on the dose of TAK-828 that will be chosen to be studied under fed conditions. Cohorts 1 and 2 were conducted in non-Japanese participants and Cohort 3 in Japanese participants.
This multi-center trial will be conducted in The United States. Participants will remain confined to the study site from check-in (Day -1) through Day 4 of each intervention period and will return 7 to 10 days after last dose of study drug for a follow-up assessment.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Dose Finding Study
Group A1= TAK-828 0.1 mg+TAK-828 3 mg +TAK-828 20 mg +Placebo, Group B1= TAK-828 0.1 mg+TAK-828 3 mg+Placebo+TAK-828 100 mg, Group C1= TAK-828 0.1 mg+Placebo+TAK-828 20 mg+TAK-828 100 mg, Group D1= Placebo+TAK-828 3 mg+TAK-828 20 mg+TAK-828 100 mg, Group
Not yet recruiting
Published on BioPortfolio: 2016-03-15T04:35:53-0400
This is a randomized, placebo-controlled, double-blinded trial. Forty patients will be randomized into two groups. The subjects in the Treatment Group will be administered with lithium ...
The purpose of the study is to verify superiority of the lafutidine group over the placebo group and non-inferiority to the famotidine group in terms of endoscopic healing rate of the pati...
Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group 1) to improve exercise capacity and delay clinical worsening. ...
The aim of this randomised, double-blind, placebo-controlled, parallel groups trial is to investigate the effects of 12 weeks resistance exercise and whey protein supplementation on multip...
A phase I, randomized, double-blinded, placebo-controlled, single ascending dose study to investigate the safety, local tolerability and transformation of nucleus pulposus following intrad...
It is the gold standard to use a placebo treatment as the control group in prospective randomized controlled trials (RCTs). Although placebo-controlled trials can reveal an effect of an active treatme...
Higher levels of fear have been shown to partly explain individual differences in placebo analgesic responding. The COMT rs4680 Val158Met polymorphism has been associated with both increased placebo a...
The aim of this study was to examine the relationships among classical conditioning, expectancy, and fear in placebo analgesia and nocebo hyperalgesia. A total of 42 healthy volunteers were randomly a...
Background The safety and efficacy of vaccines to prevent Ebola virus disease (EVD) were unknown when the incidence of EVD was peaking in Liberia. Methods We initiated a randomized, placebo-controlled...
Purpose: Vascular Endothelial Growth Factor (VEGF) and interleukin-8 (IL-8) appear important in tumor growth. In this study, we have investigated the effect of copper reduction along with gamma knife ...
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
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.
A group of enzymes that catalyzes the transfer of a phosphate group onto a nitrogenous group acceptor. EC 2.7.3.
The informal or formal organization of a group of people based on a network of personal relationships which is influenced by the size and composition, etc., of the group.
A group of enzymes that transfers a phosphate group onto an alcohol group acceptor. EC 2.7.1.