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Healthy Volunteers clinical trials

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NCT ID: NCT01018823 Completed - Healthy Volunteer Clinical Trials

A Multiple Dose Study Of Ertugliflozin (PF-04971729, MK-8835) In Otherwise Healthy Overweight And Obese Volunteers (MK-8835-037)

Start date: December 14, 2009
Phase: Phase 1
Study type: Interventional

Ertugliflozin (PF-04971729, MK-8835) is under development for the treatment of Type 2 Diabetes. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of ertugliflozin.

NCT ID: NCT01015040 Completed - Healthy Volunteers Clinical Trials

Relative Bioavailability Study of Solifenacin Succinate Liquid Suspension (Fed and Fasting) Versus VESIcare Tablet (Fasting) in Healthy Volunteers

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

The objective of the study is to compare the relative bioavailability and pharmacokinetics of solifenacin succinate suspension versus tablet.

NCT ID: NCT01012700 Completed - Healthy Volunteers Clinical Trials

Study to Evaluate the Safety and Immunogenicity of Poly ICLC (Hiltonol) in Healthy Volunteers

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

Vaccines induce protective immunity against numerous infectious diseases. However, current vaccines have limited efficacy against challenging infections like tuberculosis, malaria and HIV. Protein vaccines are safe but, typically, they induce weak T cell immunity when administered alone. Therefore, special attention is being given to adjuvants, which are enhancers of immunity, that mature antigen presenting immunostimulatory dendritic cells (DCs). Our goal is to study in humans the mechanism whereby synthetic adjuvants, acting on defined pattern recognition receptors (PRR), enhance T and B cell immunity. In preclinical studies, the investigators' laboratory has found in mice that poly IC and its analog poly ICLC are superior adjuvants for T cell mediated immunity relative to other agonists for PRR. In this study the investigators propose to study the safety and the innate immune responses to poly ICLC in multiple blood cell types, including three different subsets of DCs when administered subcutaneously or intranasally to healthy volunteers. Poly ICLC is a stabilized double stranded RNA which has been extensively studied in humans with a favorable safety profile.

NCT ID: NCT01012310 Completed - Healthy Volunteers Clinical Trials

Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects

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

The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).

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: 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: 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: 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.