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Healthy Volunteers clinical trials

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NCT ID: NCT04757532 Completed - Healthy Volunteers Clinical Trials

Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers.

ESPAMA
Start date: December 3, 2020
Phase: Phase 1
Study type: Interventional

Background: The use of stimulants such as bupropion, enzyme inhibitors such as anastrozole, androgens such as testosterone, antigonadotropins such as danazol, and diuretics such as chlorthalidone have been reported in urine drug testing programs for a wide variety of applications, including anti-doping tests in sport. These substances are subject to screening studies by the World Anti-Doping Agency (WADA). Anastrozole, chlorthalidone, testosterone and danazol are included on the WADA list of prohibited substances, while bupropion is included in the 2020 follow-up schedule of substances. This study aims to characterize the urinary excretion patterns of these substances following the administration of a single dose of each drug at a recommended therapeutic dose. Hypothesis: The administration of bupropion, anastrozole, testosterone, danazol or chlorthalidone in healthy subjects allows the generation of detectable concentrations of the drug in urine using the liquid chromatography technique coupled to mass spectrometry (LC-MS). Positive urine samples will enable to identify analytical strategies for doping control. Objectives: Primary objective: To measure the concentrations of various drugs (anastrozole, bupropion, chlorthalidone, danazol and testosterone) and their metabolites in urine for anti-doping control samples. The detection of new metabolites excreted in urine for longer periods of time than conventional metabolites will improve the ability to detect the abuse of anabolic steroids in sport. Secondary objective: To assess safety and tolerability of the drugs used. Methods: Phase I, unicentric, open, non-randomized, non-controlled clinical trial, with 5 parallel treatment conditions (anastrozole, bupropion, chlorthalidone, danazol and testosterone) administered in a single dose to male healthy volunteers (total n=11).

NCT ID: NCT04753710 Completed - Healthy Volunteers Clinical Trials

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

Start date: June 29, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The study assess efficacy, safety and tolerability of Chloroprocaine 3% ophthalmic gel in healthy volunteers.

NCT ID: NCT04753580 Completed - Healthy Volunteers Clinical Trials

Sampling of Human Microbiota in Order to Test, on a Mouse Model, Individualized Intervention Strategies During Aging

FRAGIBIOTE
Start date: October 4, 2021
Phase: N/A
Study type: Interventional

Human microbial flora transfer studies in rodent models have clearly identified that age-associated microbiota dysbiosis can play a decisive role with respect to pathologies or complications linked to aging: increased intestinal permeability, in place of systemic inflammation, dysfunction of immune cells and insulin resistance. This trial therefore aims to validate the process of ex vivo transfer to the rat of human microbiota selected from three categories of male individuals: young adults, healthy older adults and frail older adults, with the evaluation of the bacterial population of stool by analysis of the 16S rRNA gene.

NCT ID: NCT04751539 Completed - Healthy Volunteers Clinical Trials

A Dose-escalation Study of AND017 in Healthy Subjects

Start date: July 16, 2018
Phase: Phase 1
Study type: Interventional

This is a phase I, randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate safety, tolerability, PKs and PDs of AND017 following oral single and multiple dose administration.

NCT ID: NCT04748926 Completed - Healthy Volunteers Clinical Trials

Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

Start date: April 7, 2021
Phase: Phase 1
Study type: Interventional

Primary Objective: - To evaluate the impact of food on the pharmacokinetics (PK) of rilzabrutinib following single oral doses to healthy subjects. - To evaluate the impact of formulation on the PK of rilzabrutinib following single oral doses to healthy subjects Secondary Objective: - To assess the safety and tolerability of single oral doses of rilzabrutinib administered under fasted and fed conditions

NCT ID: NCT04748536 Completed - Healthy Volunteer Clinical Trials

Safety and PK of Repeated Doses of IRL201104 in Healthy Volunteers

Start date: January 29, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers.

NCT ID: NCT04746287 Completed - Healthy Volunteers Clinical Trials

Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects

Start date: January 14, 2020
Phase: Phase 1
Study type: Interventional

This is a first-in-human study of CKD-510 in single-ascending dose and multiple-ascending dose in healthy subjects. This trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics of food effects of CKD-510.

NCT ID: NCT04743414 Completed - Healthy Volunteers Clinical Trials

Drug-drug Interaction Study of CTP-543 and Itraconazole in Healthy Adult Subjects

Start date: March 2, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1 open-label study of the effect of itraconazole on the pharmacokinetics of CTP-543 in healthy subjects.

NCT ID: NCT04742517 Completed - Healthy Volunteers Clinical Trials

A Study of MA-0217 (ASP1128) in Healthy Adult Subjects and Healthy Elderly Subjects

Start date: November 20, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the safety and tolerability of single ascending intravenous doses of ASP1128 in healthy adult male and female subjects and multiple ascending intravenous doses of ASP1128 in healthy adult male and female subjects and healthy elderly male and female subjects. This study will also evaluate the pharmacokinetics and the effect on the QT interval using Fridericia's correction formula (QTcF) in these subjects.

NCT ID: NCT04737876 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of BX002-A in Healthy Adults

Start date: October 28, 2020
Phase: Phase 1
Study type: Interventional

The purpose of study BMX-02-001 is to evaluate the safety, tolerability and feasibility of orally administered BX002-A to deliver viable bacteriophages to the gut.