Healthy Volunteer
Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib
Phase I study designed to test the hypothesis that overencapsulated celecoxib 200 mg qd is bioequivalent to commercial celecoxib 200 mg qd. Approximately 90 healthy volunteers will be randomized to yield approximately 80 completers. The study is an open label, randomized, 2-way crossover with single dosing followed by a 7-day washout period between treatment arms
A Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator.
The purpose of the study is to determine the effects of the compound AZD7325 as compared to lorazepam on sleepiness, concentration and brain activity.
A Study To Investigate Safety, Blood Levels And Effects Of Giving GW642444, By Mouth, By Inhalation & By Injection
This study will involve the use of a new medicine called GW642444 being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the study is to see how safe and how well tolerated the study drug is when it is given as a liquid by mouth or by injection into a vein. In addition the study will measure how much of the medicine gets into the bloodstream when it is given by mouth, by injection into a vein and inhaled, and how long the body takes to get rid of it.
AZD7325 Multiple Ascending Dose Study
This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD7325 after single and repeated ascending doses.
AZD6280 Multiple Ascending Dose Study
This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD6280 after single and repeated ascending doses.
To Estimate Relative Bioavailability of 5 Formulations of Ronacaleret Given to Healthy Postmenopausal Females
This study will examine the effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a single oral dose of each formulation, with five formulations of SB-751689 tested in total. Blood samples will be taken up to 24 hours postdose after each dose administration. This study will provide information for future possible formulation development of SB-751689 for Phase III.
Visual Motor Coordination
Background:
- The relation between eye movement and brain function is a subject of interest to the National Eye Institute.
- By comparing eye movement in healthy volunteers to research conducted on patients who have difficulty moving their eyes, the National Eye Institute hopes to develop and improve diagnostic procedures for people with eye diseases.
Objectives:
- To study eye movement in 100 healthy adult and child volunteers.
- To understand how individuals see visual patterns and how eye movement affects the ability to see.
Eligibility:
- Volunteers must have no serious illnesses and must be 2 years of age or older (5 years of age or older if contact lenses are used to record eye movement).
- Volunteers who are 5 years of age or older must be willing to wear contact lenses that record eye movement.
- Individuals with a history of eye or brain diseases, or previous eye or eye muscle surgery, are not allowed to participate in this study. Individuals who are currently using eye medications also are not eligible for the study.
Design:
- Participants will visit the National Eye Institute outpatient clinic for examination and testing.
- Participants will be screened with a medical history and eye examination (including eye pressure and eye movement tests).
- Participants with healthy eyes will participate in eye movement testing experiments:
- One or more sessions lasting less than three hours each.
- Eye movements will be recorded with either a special contact lens or a video/infrared camera system.
- For the majority of the studies done under this protocol, only one or two sessions will be required. A few studies recording very small eye movements will require three or more sessions.
A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects
This study is a 4 period study to see if there is any interaction between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects
Spaced Versus Massed Skill Learning
This study will explore the optimum training schedule for stroke patients to learn motor skills. It will see if motor training is more effective when training sessions are distributed over time (spaced training) or when the sessions are scheduled close together (massed training). The results of this study may help researchers devise the best training schedule for patients to derive the maximum benefit from rehabilitation therapy. Healthy normal volunteers and people who have had a stroke may be eligible for this study. Patients must be 3 months post-stroke. All participants must be right-handed and between 18 and 80 years of age. Participants practice a pinch motor task and receive transcranial magnetic stimulation (TMS). Hand muscle activity is measured using surface electromyography (EMG). Pinch training involves training the participant to pinch as strongly as possible, using a device that records the force. For TMS, a wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. For surface EMG, electrodes (small metal disks) are filled with a conductive gel and taped to the skin over the muscle. Following one practice session of pinch task training and TMS, participants have four training sessions, which are scheduled 24 hours, 2 weeks, 1 month and 3 months after the practice session. For the 4- to 5-hour practice session, subjects do the following:
- Perform a single session of pinch motor task for familiarization
- Undergo TMS to measure brain activity
- Practice five 6-minute blocks of pinch motor task with rest periods between sessions and perform a calculation task (addition and subtraction tasks) during each rest period
- Receive TMS over 15 minutes. (Some sessions may have sham TMS.)
- Read books and magazines during a 45-minute rest period
- Perform a single block of the pinch motor task
- Undergo TMS to measure brain activity
- Complete a questionnaire that measures attention, fatigue and mood
For the remaining four sessions, participants perform one practice block and TMS. Each session lasts about 2 hours.
Improving the Efficacy of Experimental Malaria Vaccine AMA1-C1/Alhydrogel® (Registered Trademark)
This study will evaluate the safety and efficacy of the experimental malaria vaccine AMA1-C1/Alhydrogel® (Registered Trademark) and determine whether a new, additional component of the vaccine may increase its effectiveness. Malaria is a debilitating and potentially fatal blood disease transmitted by a parasite found in certain mosquitoes. The AMA1-C1 vaccine has been designed to create an immune response against the parasite and prevent the disease. The purpose of the study is to determine whether the additional component-protein pieces known as CpG- improves the immune response to the vaccine without causing problematic side effects. Volunteers must be healthy adults between 18 and 45 years old. Individuals who have had malaria in the past or have recently traveled to areas where malaria is endemic will be excluded from the study. Candidates will be screened with a physical examination, blood tests, and medical history. Participants will be involved in a three-stage study. In the first stage, a group of participants will receive either a high dose of the vaccine alone or a low dose combined with the CpG protein. In the second stage, a different group of participants will receive a high dose of the vaccine alone or a high dose combined with CpG. In the third stage, a larger group of participants will receive a high dose of the vaccine alone or a high dose combined with CpG. The vaccine will be injected into the muscle of the upper arm, and all participants will receive three doses of the vaccine with 28 days between doses to monitor possible reactions and side effects. Participants will be monitored for 30 minutes after each injection and will record any symptoms they experience over the six days after receiving their dose. In addition, participants will be examined over the course of six months during and after the trial with physical exams and blood and urine tests.
