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Healthy Volunteers clinical trials

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NCT ID: NCT03381144 Terminated - Healthy Volunteers Clinical Trials

A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Multiple Ascending Doses of GDC-0334 and the Effect of Food on the Pharmacokinetics of GDC-0334 in Healthy Adult Participants

Start date: December 8, 2017
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, single-center, three-part study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single and multiple ascending doses of GDC-0334 and the effect of food on the pharmacokinetics of GDC-0334 in healthy adult participants.

NCT ID: NCT03380780 Completed - Healthy Volunteers Clinical Trials

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers

Start date: March 12, 2018
Phase: Phase 1
Study type: Interventional

This single-center, open-label study will evaluate the pharmacokinetics, safety, and tolerability of emicizumab following a single subcutaneous (SC) administration to healthy Chinese subjects.

NCT ID: NCT03378310 Completed - Healthy Volunteers Clinical Trials

A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference Tablet

Start date: December 21, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, randomized study in healthy participants to evaluate the absorption of a BMS-986205 tablet into the bloodstream compared to a reference tablet. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single, oral dose of BMS-986205 twice over 22 days. Participants must remain at the clinical facility for the duration of the study.

NCT ID: NCT03376529 Completed - Healthy Volunteers Clinical Trials

Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741

Start date: November 10, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase 1, single-center, multi-arm, open-label, randomized, three-period, crossover study to evaluate the drug-drug interaction, pharmacokinetics, safety, and tolerability of a single dose of SPR741 combined with each of 3 different partner antibiotics (ceftazidime or piperacillin/tazobactam or aztreonam) in healthy volunteers. Participants will be administered single doses of SPR741 alone, a single dose of SPR741 in combination with 1 of 3 different partner antibiotics, and the partner antibiotic alone in a randomized sequence. Twenty-seven (27) adult male and female normal healthy participants 18 to 55 years of age are planned to participate in the study. Women of childbearing potential will not be eligible to participate.

NCT ID: NCT03375138 Completed - Healthy Volunteers Clinical Trials

A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes

Start date: December 4, 2017
Phase: Phase 1
Study type: Interventional

This study compares the movement of Belatacept drug products, whose active pharmaceutical ingredient has been manufactured by 2 different processes, into, through and out of the body (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned to one of two groups, and will receive a single dose of a belatacept product once during a 4-day stay at a study site.

NCT ID: NCT03373747 Completed - Healthy Volunteers Clinical Trials

Reliability and Physiological Analysis of an Isometric Test of Localized Muscular Fatigue

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Introduction: The isokinetic dynamometer, considered a gold standard tool for physical evaluation, is widely used in studies that aim to evaluate the reliability and reproducibility of localized muscular endurance (LME) tests. However, such tests may not represent full LME by fixing time or number of replicates. Therefore, it is relevant to construct a test that respects the actual capacity of each subject to withstand fatigue and to submit such a test to validation, as well as to physiological analysis. Research objectives: To assess the inter- and intra-rater reliability of a localized isometric endurance test (IET) on the isokinetic dynamometer and to establish the metabolic demand required during the test. Design: Reliability study with test-reteste dynamic. Participants and Setting: After fulfilling the eligibility criteria, eighty-eight male participants will participate in the study. Procedure: In phase 1 forty-eight participants will submitted to reliability of the IET within three sessions: familiarization session, test session and retest sessio. In phase 2 forty participants will be submitted the metabolic demand required during the IET will be analyzed by means of gas analysis, blood lactat concetrate and muscular activation percentage. Intervention: isometric endurance teste. Measurements: The measurements include time of execution of test, work of test, physiological and psychological outcomes.

NCT ID: NCT03372616 Not yet recruiting - Healthy Volunteer Clinical Trials

coMparison Between invAsive and Non-invasive assessmenT on Blood Pressure and Cardiac Function in HealthY Participants

MATCHY
Start date: January 2018
Phase: N/A
Study type: Observational

This is a cross-sectional cohort study which aims to compare the invasive and non-invasive assessments on aortic blood pressure and cardiac funtion in subjects without history of cardio-vascular disease. Left ventricular (LV) filling pressure, LV volume, and aortic blood pressure will be measured invasively. Non-invasive assessment includes echocardiography,aortic, and carotid blood pressure measurement.

NCT ID: NCT03368846 Completed - Healthy Volunteers Clinical Trials

Open, Single-dose/-Period Study to Assess Mass Balance Recovery, Metabolite Profile/Identification of 14C-Varlitinib

Start date: November 23, 2017
Phase: Phase 1
Study type: Interventional

This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects. It is planned to enrol a single cohort of 6 healthy male subjects to ensure data in 4 evaluable subjects. Each subject will receive a single administration of 120 mg [14C] varlitinib oral suspension containing not more than (NMT) 2.9 MBq (79 µCi), in the fed state.

NCT ID: NCT03366974 Completed - Healthy Volunteers Clinical Trials

Assessment of Change in CYP3A Activity by Route of Administration Using Metabolic Markers in Healthy Male Volunteers

CYP_IVPO
Start date: December 28, 2017
Phase: Phase 1
Study type: Interventional

The study objective is to evaluate and validate of endogenous markers for the assessment of change in CYP3A activity by route of administration in Korean healthy subjects using metabolomics. In addition, we aim to screen novel endogenous marker, which could determine the total or intestinal CYP activity.

NCT ID: NCT03365934 Completed - Healthy Volunteers Clinical Trials

Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds

Start date: November 20, 2017
Phase: N/A
Study type: Interventional

This single center, randomized, 15-day clinical trial is being conducted to assess the changes to the skin microbiome of induced wounds on the back in approximately 35 healthy adult subjects aged 18-55 years, with Fitzpatrick Skin Types I - III. Microbiome and skin physiology assessments will be completed.