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229 active trials for Healthy Volunteers

Neural and Psychological Mechanisms of Pain Perception

Background: - Painful stimuli cause changes in a network of brain regions called the Pain Matrix. But most of these regions respond to many other stimuli, not just pain. Researchers want to understand how different factors influence pain. They want to test what happens when people expect different levels of pain and receive treatments that can modify pain. They want to see if these factors influence decisions about pain and how the body responds to it. They also want to compare pain with responses like taste and vision. Objectives: - To better understand how pain and emotions are processed and influenced by psychological factors. Eligibility: - Healthy volunteers ages 18 50. Design: This study requires 1 to 2 clinic visits that last 1 to 3 hours. Participants will be screened with medical history and physical exam. Some participants will have one or more magnetic resonance imaging (MRI) scans of their brain. For MRI, participants will lie on a table that slides in and out of a cylinder. The scanner makes loud knocking noises. They will get earplugs. Participants heart activity will be recorded with electrocardiogram. Their pulse, sweating, and breathing will be monitored. Some participants will take a taste test. Others may perform simple tasks. Others may receive pain in their arm, leg, or hand. The pain will come from heat or electric shocks. Others may judge pain using a topical pain-relieving cream. Some of these tests may be given during MRI. Participants will fill out questionnaires. The study will last 3 years.

Start: June 2015

Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (BCRP)

This is a randomized, two-arm crossover study. Subjects will undergo a placebo and rosuvastatin phase and eltrombopag and rosuvastatin phase to identify biomarkers for Breast Cancer Resistance Protein (BCRP).

Start: September 2021

Effects of Cerebral and Peripheral Electrical Stimulation on Conditioned Pain Modulation in Healthy Subjects.

The Neuromatrix pain model and new findings on pain chronification process point to a greater efficacy of treatments that address central and peripheral rather than only peripheral structures. Both cerebral and peripheral electrical stimulations can modulate brain areas involved in pain processing. However, their effects on pain modulation systems and clinical outcomes are lacking. This study aims to investigate the efficacy of transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES) alone as well tDCS combined with PES on pressure pain threshold and conditioned pain modulation in healthy subjects.

Start: December 2018

Sociocultural & Biobehavioral Influences on Pain Expression and Assessment

Background: People can feel different levels of pain. This may depend on social, cultural, and biological factors. These factors can also influence how people respond to each other, and how they judge other people s experiences. Researchers want to learn more about these relationships. Objective: To study if social and cultural factors lead to differences in pain experience and how pain is interpreted by other individuals. Eligibility: Healthy adults ages 18-60 Design: Participants will have 1 or 2 visits. Participants will be screened with a medical history and nursing assessment. Participants may have the following: Electric shock through small sticky pads on the arm, leg, or foot. Thermal stimulation. A device called a thermode will be placed on the arm, leg, or foot. A computer controls the thermode temperature. Lowering their hand into very cold water. Videos or pictures of the face will recorded while participants get painful stimulation. A test to record heart electrical activity. Small metal disc or sticky pad electrodes will be placed on the chest. Pulse rate and breathing measured. Sweating will be measured with two small sensors stuck on the hand. A test to measure the electrical activity of facial muscles. Small metal disk or sticky pad electrodes will be attached to the skin. Viewing pictures and/or videos of other people who get painful and nonpainful stimulation. Participants will make decisions about the images. They will respond by keyboard, mouse, or button. Eye tracking. A camera will measure participants pupil size and follow their eye movements. ...

Start: May 2018

A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes

This study is investigating the safety and tolerability of the new investigational product NNC0363-0845, its concentrations in the blood and its effect on the blood sugar for the treatment of diabetes. The study consists of 3 parts. The first part of the study is conducted in healthy people, while the second part involves people with type 1 diabetes (T1D). Part 3 of this trial involves also people with T1D. The study will test how NNC0363-0845 is tolerated by the body, how it is taken up in the blood, how long it stays there and how much the blood sugar is lowered. Healthy volunteers will either get NNC0363-0845 or placebo - which treatment is decided by chance. Participants with type 1 diabetes will either get NNC0363-0845 or insulin degludec (Tresiba®), also decided by chance. It is the first time that NNC0363-0845 is tested in humans. Participants will get one dose of NNC0363-0845 or placebo or insulin degludec injected into their left thigh. Participation in the study will last for up to 6 weeks. There will be one Informed Consent visit and 6 clinic visits with the study doctor. Healthy volunteers will have blood sampling to measure blood sugar and the concentration of the investigational product in the blood. Participants with type 1 diabetes will have a clamp experiment where the blood sugar is measured and controlled for up to 42 hours. For Part 3, the total duration of the trial for each individual is expected to be approximately 3-9 weeks. Participants cannot be in the study if the study doctor thinks that there are risks for their health. Women can only take part in the study if they are of non-child bearing potential.

Start: September 2020

Study of Somatosensory Responses During Millimeter Waves Application

The brain activity induced by a sensory stimulus and measured by magnetoencephalography will be compared before and after exposure to millimeter waves. We hypothesize that brain activity is modified after exposure to millimeter waves. The neuromodulatory effects of millimeter waves may lead to future development on therapeutic management in anxiety and pain.

Start: April 2021

Physiological Changes Exploration During the Hypnotic State

Use of hypnosis for therapeutic purposes tends to spread. However, the neural mechanisms underlying hypnosis is still debated and no specific change has yet been associated with this state. In this context, it seems necessary to clarify its mechanisms and effects. Since hypnosis induces a change of consciousness state, the investigators hypothesize that this modification is accompanied by neural activity changes recordable with magnetoencephalography (MEG). The primary objective of this study is to identify neural activity changes during hypnotic trance in healthy volunteers.

Start: December 2019

Sample Collection From Healthy Volunteers for Assay Optimization

Background: The Laboratory of Immune System Biology (LISB) works with other labs at the National Institutes of Health. They study how parts of living things come together to make a whole. LISB designs and improves research tests on human samples like blood and cells. In order to do its work, LISB needs to have a lot of these samples available. Objective: To collect biological specimens to use for designing and improving research tests. Specimens include blood, stool, saliva, and skin/mucosal swabs. Eligibility: Healthy people ages 18-80 Design: Participants will be screened with an interview about their general health and their medical history. They will have a physical exam and blood tests. If the results of the screening are normal, participants will be asked to give one or more of these samples: Blood will be drawn from an arm vein with a needle and syringe. Mucus and skin will be collected by rubbing the area with a cotton swab. The areas may include the top of the tongue, inside the cheek, nostrils, behind the ear, elbow pit, or vagina. Participants will spit into a tube to collect saliva. Participants will pass stool into a plastic container that fits in the toilet under the seat. They will get sampling kits and instructions. Over the next 5 years, if more samples are needed, participants will be contacted to set up another visit to the NIH. These visits will each take about 1 hour. About every 2 years, when participants come to NIH for a visit, extra blood will be collected. It will be tested for HIV and hepatitis B and C.

Start: June 2018

A Study to Assess the Safety and Tolerability of E2511 in Healthy Participants

The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of E2511 following single ascending oral doses in healthy adult and elderly participants.

Start: September 2020

A Food Effect Study of ZN-d5 in Healthy Female Volunteers

This is a single-center, sequential, open-label, food effect study to determine the comparative bioavailability of ZN-d5 under fasting and fed conditions, following single-dose oral administration of ZN-d5. The study will be comprised of a pre-study screening, followed by administration of a single dose of ZN-d5 under fasted conditions, a washout period, administration of a single dose of ZN-d5 under fed conditions, and a follow-up period.

Start: June 2021

Care of the Urothelial Cancer Patient and Prospective Procurement of Urothelial Cancer Tissue

Background: Urothelial cancer is cancer of the bladder, ureter, and urethra. Researchers want to better understand what changes in a person s cells and genes cause this cancer to form. This may help them find new ways to treat it. Objective: - To perform DNA sequencing to help researchers learn the differences between normal tissue and tumor tissue. Also, to learn how molecular changes - including gene changes - might help predict the course of disease and how people respond to therapy. Eligibility: - Adults age 18 and older who have or are suspected of having urothelial cancer or an inherited disorder that raises their risk of getting bladder cancer. Design: Participants will be screened with a physical exam. Their medical records and tissue samples will be reviewed. Eligible participants will give tissue blocks of their original tumor. The blocks will be put in a tissue bank. Participants medical records may be reviewed. Participants may have a medical history and physical exam. Participants may have blood and urine tests. They may have imaging scans. They may give urine, blood, and saliva samples. These samples may be used in future research. If participants need surgery for their cancer, researchers will keep some of the tissue (both tumor and normal tissue). The tissue may be used in future research. Participants will go back to the Clinical Center in 6 months. They may give saliva, urine, and blood samples. After 6 months, they will be seen by their local doctor for standard post-surgical visits. Participants will be called every 6 months to give health updates.

Start: November 2015

A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects

This is a randomized, double-blind study to evaluate the safety, tolerability and PK of single and multiple ascending oral doses of RP7214. The relative bioavailability in fed and fasting conditions will also be evaluated for RP7214. The study comprises three parts; Part 1: Single ascending dose, Part 2: Multiple ascending dose and Part 3: Food effect.

Start: December 2020

Impact of Steady State Cobicistat and Darunavir/Cobicistat on the Pharmacokinetics and Pharmacodynamic of Oral Anticoagulants (Rivaroxaban, Apixaban) in Health Volunteers

Background: Rivaroxaban and apixaban are blood thinners. People with HIV may need to take them to treat or prevent blood clots. The anti-HIV drug darunavir (DRV) can increase the amount of these blood thinners in the body. This can cause bleeding or other health problems. The drug cobicistat (COBI) is used to help anti-HIV drugs work better. Researchers want to give healthy people DRV combined with COBI to learn how it affects rivaroxaban or apixaban blood levels. Objective: To test blood levels of rivaroxaban or apixaban when taken with COBI and DRV/COBI. Eligibility: Healthy volunteers ages 18-65 Design: Participants will be screened with: Medical history Physical exam Fasting blood and urine tests. (Urine tests will be performed in females of child-bearing potential only) Participants will have 8 visits; 3 are long (about 10-12 hours) and 5 are about 1 hour. They include: Baseline and final visits: Fasting blood and urine tests Day 1 visit (long day): Fasting blood and urine tests Catheter placement: A needle will insert a small tube into the participant s arm vein. Blood will be drawn up to 10 times. Dose of rivaroxaban or apixaban Day 2 visit (short day): <TAB>Fasting blood tests Dose of COBI Participants will receive a bottle containing COBI tablets to take at home. Day 7 (long day): Fasting blood and urine tests Catheter placement: A needle will insert a small tube into the participant s arm vein. Blood will be drawn up to 10 times. <TAB>Dose of rivaroxaban or apixaban <TAB>Dose of COBI Day 8 (short day): Fasting blood tests Dose of DRV/COBI Participants will receive a bottle containing DRV/COBI tablets to take at home. Day 13 (long day): Fasting blood and urine tests Catheter placement: A needle will insert a small tube into the participant s arm vein. Blood will be drawn up to 10 times. <TAB>Dose of rivaroxaban or apixaban <TAB>Dose of DRV/COBI Day 14 (short day): Fasting blood tests Participants will take COBI tablets daily at home on days 3-6, and DRV/COBI on days 9 -12 during the study. They will record doses and side effects. During the study, participants cannot: Take most medications. Drink alcohol, smoke, or vape Engage in activities such as contact and extreme sports

Start: June 2019

Investigation of the Gut Microbiome and Statin Response

There is evidence that the bacteria that naturally reside in the gut can influence how well we respond to medications. Therefore this study will look at how rosuvastatin, a medication used to lower cholesterol levels, may change the bacteria in the gut. Investigators will also examine how the gut bacteria will affect the ability of rosuvastatin to lower cholesterol levels. There will be 4 study visits over the course of about 16 weeks.The expected duration of the study is 2 years. Investigators plan to enroll 100 healthy volunteers during that time.

Start: February 2020

A Single Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of RBD1016

This is a single dose-escalation phase ?a clinical study to observe the safety and pharmacokinetic profiles of RBD1016 in healthy subjects. The study consists of screening period (Day -28 to Day -1), treatment period (Day 1 to Day 2), safety assessment period (to Day 29) and safety follow-up period (up to Day 85).

Start: February 2021

A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function

The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of fezolinetant and ES259564 (fezolinetant metabolite) in female participants with varying levels of renal impairment (mild, moderate and severe) compared to healthy female participants with normal renal function. This study will also evaluate the safety and tolerability of a single oral dose of fezolinetant in female participants with varying levels of renal impairment (mild, moderate and severe) and healthy female participants with normal renal function. Renal function will be measured by estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease (MDRD) formula: Mild (eGFR 60 to < 90 mL/min per 1.73 m^2) renal impairment; moderate (eGFR 30 to < 60 mL/min per 1.73 m^2) renal impairment, severe (eGFR < 30 mL/min per 1.73 m^2) renal impairment and not on hemodialysis and normal (eGFR ? 90 mL/min per 1.73 m^2) renal function.

Start: August 2020

VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

This is a 2-part first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-9945.

Start: June 2021

Effect of Individualized Training Versus Non-individualized Training to Improve Quality of Life of Sedentary Employees

The practice of a physical activity, even moderate, plays an important role in the prevention and the management of the main chronic non-communicable diseases (cardiovascular diseases, certain cancers, diabetes, obesity, osteoporosis ...) as well as by improving psychological health. Several studies have shown that physical activity has a positive impact on the economy of companies via the reduction of absenteeism and the improvement of productivity. However, it seems important to individualize these recommendations in order to prescribe the best possible dose of physical activity for each individual. In this project, the investigators want to test the physical qualities of employees in order to prescribe the best possible dose of physical activity with the ultimate goal of improving quality of life.

Start: April 2021

Clinical Trial to Evaluate UV-light-induced Allergic Skin Reactions After Application of Delgocitinib Cream

Participants will have study medicine applied by site staff- delgocitinib cream or vehicle, and then exposed to UV light. The trial is designed to find out if delgocitinib cream can cause skin photoallergy after UV-light exposure in people with healthy skin.

Start: March 2021

Flucloxacillin as an Inducer of CYP-enzymes

Worldwide there is an increase in antibiotic resistance which may have potential fatal long-term consequences. This is due to extensive use and sometimes misuse of antibiotics in the treatment of harmless infections. The aim of this study is to investigate if treatment with flucloxacillin increases drug metabolism in healthy volunteers through induction of cytochrome P450 (CYP) enzymes, CYP1A4, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. The hypothesis is based on an in vitro study showing that flucloxacillin activates a receptor (PXR) responsible for transcription of CYP enzymes. Trial subjects will ingest flucloxacillin for 31 days and at day 10 and 28 ingest a cocktail of 6 drugs to determine if the CYP enzymes have been induced. Plasma and urine will be drawn over 72 hours to determine the concentration of the 6 drugs and their metabolites. Change in flucloxacillin concentration will also be measured at day 9 and 27 to establish if flucloxacillin induces its own metabolism.

Start: March 2021