View clinical trials related to Healthy Volunteers.
Filter by:This open-label study will investigate whether multiple oral doses of Posaconazole affect the single dose pharmacokinetics of RO5424802 in healthy volunteers.
A Phase 1, open-label randomized crossover trial in Healthy Volunteers to evaluate the PK/PD of TI (Technosphere® Insulin) prepared with insulin from two different suppliers.
To investigate whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce the number of subjects with impaired muscle strength following adductor canal block. We hypothesized that adductor canal block with 10 ml 0.1% ropivacaine preserves quadriceps strength compared with an adductor canal block with 30 ml.
This type of study is called a radiolabeled study. For this study, LY2801653 (study drug) has been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally occurring radioactive form of the element, carbon. This study will increase understanding about how the drug appears in the blood, urine, and stool after it is administered to healthy people. Information about any side effects that may occur will also be collected. This study will last up to 15 days for each participant, not including screening. Screening is required within 28 days prior to enrollment.
This non-randomized, single group, open-label study will investigate the mass balance, routes of elimination, pharmacokinetics, and metabolism of a single oral dose of RO5424802 and the pharmacokinetics of a 14C-labeled tracer in healthy volunteers
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of MHAA4549A in healthy volunteers in an influenza challenge model. Subjects will be intranasally oculated with the challenge virus and will be randomly assigned to receive a intravenous dose of either MHAA4549A or placebo. In the stage 5 cohort, subjects will be randomly assigned to receive doses of MHAA4549A or placebo or Tamiflu (oseltamivir) orally twice daily for 5 days. All subjects in all cohorts may take Tamiflu twice daily from Day 7 to Day 11.
This 4-part study will assess the effect of formulation, food, and active pharmaceutical ingredient (API) lot on the pharmacokinetics of GDC-0032 in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study, and Parts 2, 3, and 4 are open-label 2-period crossover studies. Participants will receive single doses of GDC-0032 capsule or tablet formulation, in the fasted or fed state.
This is a Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort® Inhalation Aerosol in Healthy Volunteers. The primary objective of the study is to determine a dose of budesonide that when formulated with glycopyrronium and formoterol fumarate in BGF MDI provides comparable systemic exposure [pharmacokinetics (PK)] to budesonide following administration of Symbicort MDI.
The purpose of this Phase 1 study is to characterize the pharmacokinetic profile (what the body does to the medication) of esketamine when given by the intranasal route (through the nose) to healthy adult Japanese and Caucasian participants.
Objective: The goal of this protocol is to improve understanding scale-free brain activity and conscious vs. unconscious processing by performing small behavioral, electrophysiological, neuroimaging and brain stimulation pilot substudies. This research is expected to help develop techniques and hypotheses for future research on these topics. We will conduct: - Pilot Substudy: Pilot substudies are exploratory in nature, in order to develop enough information to generate a hypothesis. The criterion for transition to a new full protocol will be acquisition of sufficient information to generate a power analysis. There are no enrollment limitations for pilot substudies. - Hypothesis-Testing Substudy is defined as a study with a specific hypothesis to be tested that can be completed with a few healthy volunteers or patients. Hypothesis-testing substudies will undergo statistical and PIRC reviews after 6 subjects (if there is one group) or after 12 (6 per arm) if two groups are studied before additional subjects are recruited. In the event of subject dropout or unsuccessful recording, replacement will be recruited. Together, the P.I. and PIRC will decide whether to continue the hypothesis substudy with more subjects without an amendment or whether an amendment or new protocol would be necessary. A memo requesting a review of hypothesis-testing substudies for possible additional enrollment will be sent to PIRC and the statistical reviewer. The memo will be forwarded to the CNS IRB. - Technical development of new experimental paradigms and data analysis methods. This protocol includes only non-invasive techniques with minimal risk (MRI, EEG, MEG, EMG, tDCS). Study Population: We plan to recruit up to 120 healthy volunteers aged 18-65. Design: We will design small projects that are pertinent to the theme of scale-free brain activity and conscious/unconscious processing. We will investigate healthy volunteers in the resting state or while they perform simple motor or sensory tasks. If a hypothesis testing substudy leads to results of interest and if a larger population is necessary to reach statistical significance, a separate protocol will be submitted with a priori hypotheses, specific study design and power analysis adapted from the pilot or exploratory substudies performed in the present protocol. In the substudies, brain activity of healthy human volunteers will be monitored by functional magnetic resonance imaging (fMRI), magnetoencephalography (MEG), electroencephalography (EEG), or simultaneous MEG-EEG. Anatomical MRI will be collected in some subjects to allow better localization of brain dynamics. Because transcranial direct-current stimulation (tDCS) is ideally suited to modulate the slow component of scale-free brain activity, we will also investigate the effect of tDCS on brain activity and/or behavioral performance in cognitive tasks. tDCS will be administered sequentially, but not simultaneously, with brain-activity monitoring by fMRI/MEG/EEG. Most experiments will be conducted in conjunction with cognitive tasks. In some experiments, we will study resting-state brain function, during which spontaneous brain activity is collected without a specific externally administered task. Outcome Measures: MRI: to analyze measures such as the anatomical structures of the brain (using structural MRI); amplitude of the blood-oxygenation-level-dependent (BOLD) signal (using fMRI); cerebral blood flow [using arterial spin labeling (ASL)] and different neurotransmitter levels in brain regions of interest [using magnetic resonance spectroscopy (MRS)]. EEG and MEG: to quantify measures such as power spectrum, event- or task-related potentials, synchronization/desynchronization, and coherence between sensors or sources located close to the brain areas of interest. tDCS: to analyze changes in behavioral measures and/or fMRI/EEG/MEG activity caused by tDCS. Behavioral measures: to quantify measures such as hit rate, reaction times, electromyography (EMG) patterns. We may measure autonomic data during the course of the experiment (such as heart rate, respiration, end-tidal CO2, skin conductance), which will be correlated with the outcome measures.