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Healthy Volunteers clinical trials

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NCT ID: NCT05134337 Completed - Healthy Volunteers Clinical Trials

Study of the Effects of Itraconazole and Rifampin on LOXO-305 in Healthy Participants

Start date: February 12, 2020
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to learn about how itraconazole and rifampin affect LOXO-305 in healthy participants. Participation could last about 8 weeks.

NCT ID: NCT05129891 Completed - Healthy Volunteers Clinical Trials

A Research Study Looking at New Protein-based Tablets in Healthy Male Participants

Start date: November 3, 2021
Phase: Phase 1
Study type: Interventional

In this study, four new tablet versions of two compounds will be investigated. The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. The tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance. Participants will receive one treatment for 10 days in the first period. For the second period, directly following, participants will receive a different treatment for five more days. The study can last for up to approximately 10 weeks for each participant. This includes a screening period (up to 3 weeks), two treatment periods (together a total of 15 days) and a follow-up visit (5 weeks after the last dosing)

NCT ID: NCT05129865 Completed - Healthy Volunteers Clinical Trials

LYT-300 in Healthy Volunteers

Start date: December 7, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Part 1 is a single ascending dose (SAD) trial in healthy volunteers (HV) to assess the safety, tolerability, and pharmacokinetic (PK) profile of orally administered LYT-300. Part 2 is a crossover assessment in HV of the effects of food on the safety, tolerability, and PK profile of orally administered LYT-300. Part 3 is a multiple ascending dose (MAD) trial in HV to assess the safety, tolerability, and PK profile of multiple doses (up to 7 days) of orally administered LYT-300. Part 4 is an assessment of the effects of LYT-300 vs. placebo on pharmacodynamic and patient reported outcome response to a validated clinical model of anxiety.

NCT ID: NCT05129644 Completed - Healthy Volunteers Clinical Trials

Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects

Start date: November 7, 2009
Phase: Phase 1
Study type: Interventional

This was a single-center, double-blind, randomized, active control, single dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) profiles of P1101 in 48 healthy volunteers.

NCT ID: NCT05129137 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg)

ARL/20/277
Start date: November 29, 2021
Phase: Phase 1
Study type: Interventional

This study aims to assess the pharmacokinetic profile of a Fixed Dose Combination nefopam hydrochloride (30 mg) / paracetamol (500 mg) and individual components taken alone or concomitantly after oral single dose.

NCT ID: NCT05127564 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants

Start date: December 3, 2021
Phase: Phase 1
Study type: Interventional

The primary objective is to evaluate the primary pharmacokinetic (PK) parameters of DRF active metabolite monomethyl fumarate (MMF) following multiple doses of DRF in Chinese and Caucasian adult healthy participants. The secondary objectives are to evaluate the secondary PK parameters of DRF active metabolite MMF following multiple doses of DRF in Chinese and Caucasian adult healthy participants, to evaluate the PK of DRF inactive major metabolite 2-hydroxyethyl succinimide (HES) following multiple doses of DRF in Chinese and Caucasian adult healthy participants and to evaluate the safety and tolerability of multiple oral doses of DRF in Chinese and Caucasian adult healthy participants.

NCT ID: NCT05121246 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetic Study Comparing MB05 (Proposed Palivizumab Biosimilar), EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers.

Start date: June 15, 2022
Phase: Phase 1
Study type: Interventional

Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the pharmacokinetics (PK), safety, immunogenicity and tolerability of MB05 with US and EU Synagis® in healthy subjects. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

NCT ID: NCT05120479 Completed - Healthy Volunteers Clinical Trials

Effects of Taping on the Proprioceptive System

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Kinesiotape (KT) is a widely used technique, although the scientific evidence on its effectiveness is limited and conflicting. KT has not yet been scientifically proven to have an effect on proprioception and a possible placebo effect of this technique cannot be ruled out. The main objective of this experimental study is to evaluate the effect of the application of KT in the anterior side of the forearm on the force sense and the positional sense compared to a placebo intervention in healthy subjects. A randomized, single-blind, crossover clinical trial will be carried out, where each subject will undergo three situations in their dominant forearm: no intervention, intervention using sham tape and intervention using KT. In the present design, in a randomized manner, all subjects go through the 3 conditions on different days: KT, sham tape, and no intervention. Measurements will be made before and after the intervention and proprioception will be measured using the variables of sense of force (with a dynamometer) and joint position (with a goniometer). The main intervention will be the application of a KT strip on the anterior face of the forearm and a sham tape of another material following the same procedure. The study population will be made up of healthy students from the university community of the Faculty of Physiotherapy of the University of Vigo. The main objective of this experimental study is to evaluate the effect of the application of kinesiotape (KT) in the anterior side of the forearm on the force sense and the joint positional sense of the wrist compared to a placebo/sham intervention in healthy subjects. Study hypothesis: the application of KT on the anterior side of the forearm produces better results in the force sense evaluated by a grip dynamometry and on the joint position sense of the wrist compared to a sham intervention or not intervention.

NCT ID: NCT05119790 Completed - Healthy Volunteers Clinical Trials

A Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of BIIB122/DNL151 in Healthy Male Subjects

Start date: August 27, 2021
Phase: Phase 1
Study type: Interventional

This is a single-center, non-randomized, open-label Phase 1 study to determine the absorption, metabolism, and excretion (AME) of BIIB122 (DNL151) following administration of a single oral dose of [14C] BIIB122 ([14C] DNL151) following a fast. The mass balance, excretion, and PK of BIIB122 (DNL151) will be used to evaluate AME.

NCT ID: NCT05118516 Completed - Healthy Volunteer Clinical Trials

Safety, Tolerability, and Pharmacokinetics of ASC43F, a Fixed Dose Combination Tablet in Healthy Subjects

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

This is a phase 1, open-label study in healthy adults. This study is aimed at evaluating the safety, tolerability, and pharmacokinetics of ASC43F, a fixed-dose combination (FDC) and single dose tablet containing ASC41, a THR β agonist and ASC42, an FXR agonist in healthy subjects.