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Healthy Subjects clinical trials

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NCT ID: NCT04819620 Completed - Healthy Subjects Clinical Trials

Pharmacokinetics of PN-232 in Healthy Volunteers

Start date: May 13, 2021
Phase: Phase 1
Study type: Interventional

This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-232 in healthy volunteers. It is a first-in-human (FIH) study for PN-232 that will be conducted in three parts. Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is crossover solid dose comparison and effect of food study.

NCT ID: NCT04808622 Completed - Healthy Subjects Clinical Trials

Safety and Efficacy of Trans Sodium Crocetinate (TSC) in Enhancing Tissue Oxygen Levels in Healthy Volunteers

Start date: March 17, 2021
Phase: Phase 1
Study type: Interventional

Randomized, double-blind, placebo-controlled, pharmacokinetic, pharmacodynamic study. Subjects will be randomized to TSC or placebo to determine the effect of Trans Sodium Crocetinate (TSC) on Transcutaneous Oximetry Measurements (tcpO2) following a single administration of TSC in subjects breathing oxygen (O2).

NCT ID: NCT04796831 Completed - Healthy Subjects Clinical Trials

A Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects

Start date: April 26, 2021
Phase: Phase 1
Study type: Interventional

Quizartinib, a selective FLT3 inhibitor, is being developed as a treatment for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The absolute oral bioavailability of quizartinib has not yet been studied. This study is designed to estimate quizartinib bioavailability of quizartinib following oral and intravenous (IV) administration.

NCT ID: NCT04796181 Completed - Healthy Subjects Clinical Trials

Heart Rate and Respiratory Rate Measurements by a Novel, Radar-based Device

Start date: February 21, 2021
Phase:
Study type: Observational [Patient Registry]

A single center, single blinded, prospective validation (including extension0 study for the accuracy and safety evaluation of Neteera 130H, a novel, radar-based contact-free device for heart and respiratory rate measurements.

NCT ID: NCT04793295 Completed - Healthy Subjects Clinical Trials

Study to Investigate Drug-Drug Interaction Between MT-7117 and Test Drugs in Healthy Subjects

Start date: March 23, 2021
Phase: Phase 1
Study type: Interventional

Study is to investigate drug levels in the blood after taking single or multiple doses of the study drug, MT-7117, in healthy adults when taken together with another drug. This study will also look at the safety and the body's ability to tolerate MT-7117

NCT ID: NCT04788017 Completed - Healthy Subjects Clinical Trials

A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects

Start date: March 24, 2021
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ziresovir following a single ascending oral dose administration in healthy adult subjects under fasted conditions.

NCT ID: NCT04779606 Completed - Healthy Subjects Clinical Trials

Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers

Start date: June 16, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The study evaluate the efficacy, safety and local tolerability of Chloroprocaine 3% ophthalmic gel as compared to matching placebo in healthy subjects.

NCT ID: NCT04764630 Completed - Healthy Subjects Clinical Trials

Clinical Study to Investigate the Pharmacokinetics of Multiple Repeated Doses of Intranasal Naloxone

Start date: March 1, 2021
Phase: Phase 1
Study type: Interventional

Intranasal (IN) naloxone is available as 2 mg or 4 mg dose with the indication to re-administer additional doses every 2 to 3 minutes (using alternating nostrils) if needed until emergency medical assistance arrives. The 4 mg dose is distributed in packages of two nasal sprays (1 dose per nasal spray), but additional doses can be administered if needed and available. While the pharmacokinetics of IN naloxone have been determined following administration of a 4 mg dose in each nostril concurrently, the pharmacokinetics have not been determined following multiple doses when there is a 2-3 minute delay between doses and when doses are re-administered to the same nostril. Obtaining data with repeat dosing will inform if and how fast naloxone plasma concentrations can be reached to be able to reverse highly-potent opioid overdoses. This study will be a randomized, unblinded, three-way crossover study to determine naloxone plasma concentration after administration of multiple doses: A. Four 4 mg IN naloxone doses (1 dose every 2.5 minutes) B. Four 4 mg IN naloxone doses (2 doses every 2.5 minutes) C. Two 4 mg IN naloxone doses (1 dose every 2.5 minutes)

NCT ID: NCT04746820 Recruiting - Healthy Subjects Clinical Trials

Functional Near-infrared Spectroscopy in Unconscious Patients

fNIRS
Start date: January 15, 2020
Phase: N/A
Study type: Interventional

The study design is a single-center prospective pilot study. Hypothesis: Results of cerebral fNIRS examination in unconscious patients with severe hemorrhagic or ischemic stroke in the ICU are congruent with the results of SSEP and AEP. Hence, making it a potential prognostic tool for unconscious ICU patients. In a specific subgroup of unconscious patients after cardiac arrest and cardiopulmonary resuscitation the fNIRS measurement is congruent with the results of electroencephalography (EEG). The primary purpose of this study is to evaluate the agreement of the results of fNIRS examination to those of evoked potentials and EEG in unconscious ICU patients with severe hemorrhagic, or ischemic strokes or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation. fNIRS will be compared to evoked potentials in an experimental group consisting of unconscious neuro-intensive care patients and in a control group consisting of healthy, conscious subjects. To compare fNIRS with evoked potentials there are two test phases: 1. The cerebral response to a somatosensory stimulus (peripheral nerve stimulation) is measured by fNIRS and SSEP 2. The cerebral response to an auditory stimulus is measured by fNIRS and AEP To avoid biases the following has to be considered: - The timing of the measurements plays an important role. A time difference between compared measurements can influence the outcome significantly due to deterioration or recovery of the neuronal network during the time gap. Therefore, fNIRS and evoked potentials will be measured simultaneously. - If the compared measurement methods are conducted by the same researcher the possibility of bias is high. Hence, two different researcher will conduct each one measurement without knowing the results of each other during the measurement.

NCT ID: NCT04729088 Withdrawn - Healthy Subjects Clinical Trials

Pharmacokinetics Trial of Isosorbide Mononitrate 0.5% Gel for Intra Anal Application in Healthy Subjects

Start date: December 20, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase I trial to evaluate pharmacokinetics and safety of Isosorbide Mononitrate gel for intra anal administration in healthy subjects.