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Healthy Volunteers clinical trials

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NCT ID: NCT01408316 Completed - Healthy Volunteer Clinical Trials

Study of the Pharmacokinetics and Pharmacodynamics of Crystalline PX-866 Tablets and Amorphous PX-866 Capsules in Healthy Volunteers

Start date: July 2011
Phase: Phase 1
Study type: Interventional

This is a two part study designed to evaluate the PK profile of PX-866 capsules versus tablets, and to evaluate the effect of food on the PK of PX-866 tablets only in healthy volunteers.

NCT ID: NCT01407406 Completed - Healthy Volunteers Clinical Trials

Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy Volunteers

Start date: September 2011
Phase: Phase 1
Study type: Interventional

Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese populations to support future clinical development of BIIB023 in China and Japan. Study Design: This is a single-dose study to assess the PK, safety, and tolerability of BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy volunteers. The Caucasian group is included to allow comparison of PK data from different groups using data from the same study under the same controlled conditions. Subjects will be in the clinic for 48 hours around the time of dosing and in the study for up to 100 days.

NCT ID: NCT01406743 Completed - Healthy Volunteers Clinical Trials

Spine Reference Parameters on EOS Imaging

EOS-SPINE
Start date: May 2011
Phase: N/A
Study type: Observational

The lumbar pain caring consists from a 3D reconstruction of the spine obtained to scan or radiography, determining the lumbar pain cause and gravity, to propose a conservative treatment in first intention or a adapted spine surgery in first or second intention (Fritzell and al ., on 2001). The analysis and the correction of postural disorders pass inevitably by a good knowledge of the not pathological posture. The validation of the acquisition 2D / 3D reconstruction by EOS ™ technology demonstrated its interest for the diagnosis and the lumbar pain caring. However, the EOS technology ™ is recent and few data were acquired with this technology for healthy population. So, this clinical study with EOS ™technology would allow to obtain a precise knowledge of the standing skeleton in position (to an asymptomatic adult population), by displaying the gravity constraints on the joints, and the compensation phenomena in normal situation. This functional information for a given age bracket would allow to propose to the patients with lumbar pain, adapted interventions to the gravity constraints considering the skeleton evolution for age bracket.

NCT ID: NCT01406171 Completed - Healthy Volunteers Clinical Trials

Drug Interaction Study of Isavuconazole and Midazolam

Start date: May 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the effect of isavuconazole at steady state on the pharmacokinetics of midazolam in healthy adult subjects.

NCT ID: NCT01406158 Completed - Healthy Volunteers Clinical Trials

A Study in Healthy Volunteers Comparing Two Different Liquid Formulations of Solifenacin With Each Other and With the Tablet Formulation

Start date: May 2011
Phase: Phase 1
Study type: Interventional

A study in healthy volunteers comparing two different liquid formulations of solifenacin with each other and with the tablet formulation.

NCT ID: NCT01402076 Completed - Healthy Volunteers Clinical Trials

A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects

Start date: August 2011
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to understand whether there is any difference in the amount of midazolam (including its breakdown product) in the blood when midazolam is given with tasimelteon, and whether there is any difference in the amount of rosiglitazone in the blood when rosiglitazone is given with tasimelteon.

NCT ID: NCT01398293 Completed - Healthy Volunteer Clinical Trials

A Study of Danoprevir in Combination With Low-Dose Ritonavir in Healthy Subjects

Start date: August 2011
Phase: Phase 1
Study type: Interventional

This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.

NCT ID: NCT01398241 Completed - Healthy Volunteer Clinical Trials

A Study of RO5267683 in Healthy Subjects

Start date: August 2011
Phase: Phase 1
Study type: Interventional

This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally daily for 28 days. Follow-up will be 10 weeks after the last dose.

NCT ID: NCT01397604 Completed - Healthy Volunteers Clinical Trials

The Effects of GLA on Human Volunteers

Start date: July 2011
Phase: Phase 1
Study type: Interventional

The advent of vaccines contributed to major improvements in human morbidity and mortality due to infectious diseases such as polio, small pox, measles and diphtheria. However infectious diseases like HIV, malaria and tuberculosis continue to be major causes of death worldwide and conventional vaccine strategies have not been successful. The fundamental problem is that current protein based vaccines do not elicit the necessary T-cell immunity. Experimentally, adjuvants can be given in conjunction with a vaccine to activate and mature the dendritic cell (DC), which can then direct an immune response to enhance T-cell immunity. One family of potential adjuvants functions through the activation of Toll-like receptors (TLR) on the DC. Major gaps exist in our understanding of adjuvant effects in humans. We hypothesize that a synthetic adjuvant directed to activate TLR4 (GLA) will safely stimulate the innate immune system when administered subcutaneously (SC) or intramuscularly (IM). Importantly, in contrast to other adjuvant trials in which adjuvant is combined with an antigen or vaccine, GLA will be tested in isolation. This is because we anticipate the future administration of GLA with our dendritic cell targeted HIV vaccine. A DC-targeted vaccine cannot be given without an immune stimulating adjuvant due to potential risk of inducing immune tolerance. Therefore, in order to understand the specific contributions of GLA versus the DC-targeted vaccine, we need to understand the GLA effects in isolation. The safety and tolerability of 2 different formulations of GLA (GLA-SE vs. GLA-AF) administered by 3 different routes (SC, ID, IM) will be the major focus of this trial. The second focus will be characterizing the innate immune response by assessing systemic cytokine and chemokine levels and determining global gene regulation following GLA stimulation. The third focus will be on the cellular effects of GLA, specifically on blood monocytes and dendritic cells. Monocytes may represent a large pool of inducible potent DC (monocyte-derived DC), however these cells have not been well characterized in humans. We will investigate the effects of GLA stimulation on the peripheral blood monocyte subsets that might give rise to monocyte-derived DC.