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Healthy Volunteers clinical trials

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NCT ID: NCT04092712 Completed - Healthy Volunteers Clinical Trials

Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers

Start date: September 5, 2019
Phase: Phase 1
Study type: Interventional

This study will assess the absorption, metabolism, excretion, mass balance, safety, and tolerability of a single oral administration of [14C]-CTP-543 in healthy male subjects.

NCT ID: NCT04092595 Completed - Healthy Volunteers Clinical Trials

A Study of PF-06651600 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants

Start date: September 26, 2019
Phase: Phase 1
Study type: Interventional

A phase 1, 2-period, fixed-sequence, multiple-dose, open-label study of the effect of PF-06651600 on Rosuvastatin pharmacokinetics in healthy participants. Approximately 12 healthy male and/or female participants will be enrolled in the study.

NCT ID: NCT04091061 Completed - Healthy Volunteers Clinical Trials

Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects

Start date: October 3, 2019
Phase: Phase 1
Study type: Interventional

The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.

NCT ID: NCT04087707 Completed - Healthy Volunteer Clinical Trials

Safety, Pharmacokinetic, and Pharmacodynamic Study of TS-142 in Healthy Subjects

Start date: September 17, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly and elderly participants

NCT ID: NCT04087278 Completed - Healthy Volunteers Clinical Trials

Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)

CHARM
Start date: September 19, 2019
Phase: N/A
Study type: Interventional

In this study, the investigators aim to determine the health benefits of red raspberry ellagitannin consumption on cardiovascular health. The study population is stratified according to the urolithin metabotypes (gut-microbial metabolic profile): UM-0, UM-A and UM-B. The investigators will evaluate changes in blood pressure, endothelial function, arterial stiffness, lipid profile, cognitive performance and gut microbiome composition.

NCT ID: NCT04086602 Completed - Healthy Volunteers Clinical Trials

Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334

Start date: September 13, 2019
Phase: Phase 1
Study type: Interventional

This is a first in human (FIH), single-centre, double -blind, randomised, cross-over, SAD followed by a MAD study of IZD334 conducted in healthy adult participants as well as an open-label cohort in adult patients with CAPS. The study is designed to evaluate the safety, tolerability, PK, PD, and food effect of IZD334 in healthy adult participants, and to evaluate the safety, tolerability, PK, PD, and preliminary clinical efficacy of IZD334 in adult patients with CAPS.

NCT ID: NCT04081376 Completed - Healthy Volunteers Clinical Trials

Generation of Biological Samples Positive to Hydromorphone for Anti-doping Control

HM
Start date: November 20, 2019
Phase: Phase 1
Study type: Interventional

Background: Hydromorphone (HM) is a semi-synthetic derivative of morphine used for pain control. Like other opiates, due to its high potential of abuse HM is included on the World Anti-Doping Agency (WADA) list of prohibited substances. Hypothesis: The oral administration of hydromorphone hydrochloride in healthy subjects allows generating detectable concentrations of the drug in urine. Positive urine samples will enable to identify analytical strategies for doping control. Objectives: Primary objective: To measure the concentrations of hydromorphone in urine for anti-doping control samples. Secondary objective: To identify metabolites and precursors of hydromorphone in urine. To assess safety and tolerability of the drug used. Methods: Phase I, open, non-randomized clinical trial, with a treatment condition (hydromorphone) administered orally to 2 subjects.

NCT ID: NCT04079101 Completed - Healthy Volunteers Clinical Trials

Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants

Start date: October 2, 2019
Phase: Phase 1
Study type: Interventional

The primary objective is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered BID for 9 days, with an additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese participants.

NCT ID: NCT04079062 Completed - Healthy Volunteers Clinical Trials

Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects

Start date: September 12, 2019
Phase: Phase 1
Study type: Interventional

To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity in Japanese and Caucasian healthy adult male subjects when ONO-4685 is administered as a single-dose by intravenous infusion.

NCT ID: NCT04077879 Completed - Healthy Volunteers Clinical Trials

Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect

Start date: September 19, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of single ascending oral doses of ASP1617 in healthy adult non-Asian and Japanese male and female participants. This study also evaluate the pharmacokinetics and determine the effect of food on the pharmacokinetics of a single oral dose of ASP1617.