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Healthy Volunteers clinical trials

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NCT ID: NCT01011296 Completed - Healthy Volunteers Clinical Trials

First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers

Start date: December 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers.

NCT ID: NCT01003444 Terminated - Healthy Volunteers Clinical Trials

Muscle Malonyl Coa Biomarker Assay Development

Start date: November 2009
Phase: Phase 1
Study type: Interventional

Biopsies of the outer thigh muscle and serum samples will be collected from untreated healthy subjects. These biological samples will be provided to the Diabetes Research Unit Translational Biomarker Laboratory for use in developing and validating human muscle malonyl CoA and serum malonate biomarker assays.

NCT ID: NCT01002625 Terminated - Healthy Volunteers Clinical Trials

A Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers

Start date: November 2009
Phase: Phase 1
Study type: Interventional

PF-04457845 has been shown to temporarily decrease the dream (REM) period of sleep in rats, which suggests that PF-04457845 is active in rat's brains. This study is designed to see whether this is also the case in man.

NCT ID: NCT00999817 Completed - Healthy Volunteers Clinical Trials

A Pharmacokinetic (PK) Study Of PF-00299804 And Dextromethorphan In Healthy Volunteers

Start date: November 2009
Phase: Phase 1
Study type: Interventional

A study to study the potential effect of PF-00299804 inhibition of CYP2D6 on dextromethorphan.

NCT ID: NCT00999154 Terminated - Healthy Volunteers Clinical Trials

Diet-Induced-Obesity Resistant Phenotypes in Humans

Start date: September 19, 2009
Phase:
Study type: Observational

Background: - Obesity is the result of many factors, including genetics and lifestyle, such as over-eating high-calorie foods and not being physically active. Obesity affects approximately one third of adults in the United States. Researchers often study individuals who are already overweight and obese, but another approach is to examine people who stay thin despite eating whatever they want and not exercising. Studying these thin individuals will enhance understanding of why some people become obese and others do not, which may lead to novel treatments for obesity. Objective: - To study the metabolism, body composition, body temperature, physical activity, and blood chemistries of healthy lean adults before and after adding 1,000 extra Calories per day to their normal diet. Eligibility: - Healthy adults, 30 to 50 years of age, who have never been overweight after adolescence, who are currently weight-stable, sedentary, and eating without restrictions. Design: - The entire study will take about 9 weeks and will include the following outpatient and inpatient visits: <TAB>- Outpatient screening visit and monitoring: Physical examination and blood test at screening; then, one week of physical activity monitoring (e.g., with a pedometer-like device called an accelerometer) and completing a food diary. <TAB>- Baseline inpatient visit (5 days): Volunteers will eat a normal diet to maintain body weight. Energy expenditure, body composition, physical fitness, activity level, and eating behavior will be measured. Urine and blood samples will be taken. Volunteers may go home for the weekend or stay at the metabolic clinical research unit (MCRU). <TAB>- Inpatient feeding week 1 (5 days): Volunteers will eat a normal diet plus milkshakes for added calories. All the same measurements during the baseline week visit will be repeated. <TAB>- Outpatient feeding weeks 2 3: Volunteers will eat breakfast at the MCRU everyday for the next 2 weeks and take prepared meals home with them (volunteers may also stay at the MCRU for the 2 weeks if they prefer). Volunteers will drink a non-radioactive (heavy) water called doubly labeled water to measure energy expenditure in their normal living environment Daily urine samples will be collected. <TAB>- Inpatient feeding week 4 (5 days): Volunteers will continue eating a normal diet plus milkshakes for added calories. This stay and measurement is identical to inpatient feeding week 1. - Volunteers will be contacted at 6 and 12 months to assess any changes in body weight, diet, and physical activity.

NCT ID: NCT00999128 Completed - Healthy Volunteers Clinical Trials

A Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0941 and the Effect of Food and Proton Pump Inhibition on GDC-0941 Tablet Pharmacokinetics in Healthy Volunteers

Start date: October 26, 2009
Phase: Phase 1
Study type: Interventional

This is a Phase I, randomized, two-part, single-center pharmacokinetics (PK) study to assess the relative bioavailability of capsule and tablet formulations of GDC-0941 in the fasted state (Part 1) and to determine the effect of food and proton pump inhibition on the PK of the tablet formulation of GDC-0941 (Part 2). Approximately 18 subjects will be enrolled in Part 1 and up to 32 subjects will be enrolled in Part 2. Subjects who participate in Part 1 are not eligible to participate in Part 2.

NCT ID: NCT00997919 Completed - Healthy Volunteer Clinical Trials

A Study of the Safety, Tolerability, Pharmacokinetics, and Bioavailability of IV and SC MABT5102A in Healthy Volunteers

Start date: October 2009
Phase: Phase 1
Study type: Interventional

This Phase I, single-dose, randomized, parallel-group, open-label study will evaluate the safety, tolerability, and pharmacokinetics of MABT5102A following subcutaneous (SC) and intravenous (IV) administration in healthy volunteers.

NCT ID: NCT00995891 Completed - Healthy Volunteers Clinical Trials

Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies

Start date: September 9, 2009
Phase:
Study type: Observational

Background: - Laboratory research studies require control samples from healthy volunteers to compare with samples from patients. These studies will help researchers better understand and refine treatments for immune system and inflammatory diseases. Objective: - To obtain blood, urine, buccal (mouth) mucosa, normal tissue and bone marrow samples and/or leukopheresis cells from healthy volunteers. Eligibility: - Healthy individuals at least 8 years of age. Design: - Volunteers will be recruited through the Program for Healthy Volunteers, Patient Recruitment and Public Liaison Office, or self-referral through the clinicaltrials.gov Web site. - Health will be confirmed by a brief history and physical examination and blood work. - Volunteers 8 years of age and older will provide blood and urine samples using standard procedures. Buccal mucosa samples will be obtained by scraping the insides of both cheeks with a sterile nylon brush. - Bone marrow samples will be obtained from volunteers 18 years of age and older by taking two aspirates from the posterior iliac crest (an area near the hip). - Normal tissue samples will be obtained from volunteers 18 years of age and older by taking superficial skin samples (punch biopsies) - Leukopheresis or lymphapheresis will be performed on volunteers 18 years of age and older to obtain white blood cells for research - Samples will be assigned a unique code and will be stored until they are no longer of scientific value or the volunteer withdraws consent for their use.

NCT ID: NCT00995605 Terminated - Healthy Volunteers Clinical Trials

AMAP102 - Safety, Tolerability and Pharmacokinetics in Healthy Subjects

Start date: April 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether AMAP102 is safe and well tolerated by humans.

NCT ID: NCT00995527 Completed - Healthy Volunteers Clinical Trials

Characterization of the Innate Immune Response in Healthy NIH Employees at Baseline and After Immunization With the H1N1 Vaccine

Start date: September 30, 2009
Phase: N/A
Study type: Observational

Background: - The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases is conducting research investigating how the swine flu (H1N1) vaccine affects the immune system. The exposure to the new swine flu vaccine gives us a rare opportunity to learn about how the human immune system responds to a new vaccine. - Researchers are interested in collecting blood samples from individuals who have received the vaccine. Participants will be selected from a group of healthy volunteers who will be receiving the H1N1 vaccine because it is mandatory for their work at the National Institutes of Health. This protocol will be one of the first studies to characterize the human innate immune response to H1N1 vaccine. Objectives: - To collect blood samples for research purposes before and after participants receive a standard non-research vaccination against swine flu (H1N1). Eligibility: - Healthy individuals 18 years of age and older who are employees of the National Institutes of Health. - Individuals who have had confirmed cases of influenza in the past year are not eligible to participate. Design: - Participants will be admitted for a 36-hour inpatient stay, during which blood samples will be taken frequently. Participants will have a standard intravenous catheter (similar to the one used for intravenous infusions) put in place to avoid multiple needle sticks. - Participants will be assigned into one of two groups; the two groups differ in the timing of blood draws but not in the overall amount of blood drawn. - Group 1: Blood samples 30 minutes before and immediately before vaccination. Additional samples will be taken 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 30, and 36 hours after vaccination. - Group 2: Blood samples 30 minutes before and immediately before vaccination. Additional samples will be taken over the following 36 hours, with exact timing to be determined based on the findings from group 1. - All participants will provide blood samples 7 days after being released from the inpatient stay. - Because of the amount of blood being drawn for research, participants should not donate blood or take part in any other protocols that collect blood while participating in this study.