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Healthy Volunteers clinical trials

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NCT ID: NCT03983239 Completed - Healthy Volunteers Clinical Trials

Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects

Start date: June 21, 2019
Phase: Phase 1
Study type: Interventional

This is a 2-part study to evaluate the effect of multiple doses of rifampin or efavirenz on the PK, safety, and tolerability of single doses of fedratinib in healthy subjects. Each study part will consist of a nonrandomized, fixed-sequence, open-label design. The study parts can be run in any order or in parallel. Subjects may participate in one part only. For each part, subjects will participate as follows: - Screening - Treatment period (includes baseline) - Follow-up telephone call (4 days [± 2 days] after discharge) During the study, blood samples will be collected at prespecified times for PK. Subject safety will be monitored throughout the study.

NCT ID: NCT03983161 Completed - Healthy Volunteers Clinical Trials

A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment

Start date: September 4, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1, multicenter, nonrandomized, open-label, single oral dose study to assess the PK of fedratinib in subjects with moderate and severe hepatic impairment, and in matched subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease.

NCT ID: NCT03979235 Recruiting - Healthy Volunteers Clinical Trials

Developing Effectiveness Evaluation and Therapeutic Programs of Rehabilitation

Start date: June 5, 2019
Phase:
Study type: Observational

Using robotics, sensors, and sEMG to develop clinic-oriented quantitative effectiveness evaluation and individualized programs of rehabilitation

NCT ID: NCT03978143 Completed - Healthy Volunteers Clinical Trials

Evaluate Taste and Relative Bioavailability of Two Microsphere Formulations of Crizotinib in Healthy Participants

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

The primary purpose of the study is to estimate the relative bioavailability and palatability of 2 new crizotinib formulations to the commercially available crizotinib formulated capsule at a 250 mg dose administered under fasted conditions in adult healthy participants. Additionally, this study aims to assess the safety and tolerability of crizotinib 250 mg single dose in 4 formulations when given fasted, with high fat meal, or with a proton pump inhibitor in healthy participants. Finally, this study will explore the effect of food or proton pump inhibitor on the pharmacokinetics of the 2 new crizotinib formulations. We hypothesize 1 of the 2 new crizotinib formulations will have improved relative bioavailability and palatability than the formulated capsule under fasted or fed conditions with or without a proton pump inhibitor.

NCT ID: NCT03978026 Completed - Healthy Volunteers Clinical Trials

Vigilance and Simulated Driving After a Nap

SOMBOX
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

The objective of this study is to assess the effectiveness of naps under different environmental conditions and a rest without nap, on driving, alertness and psychomotor performance. This study also aims to record during nap time, sleep, body temperature and heart rate.

NCT ID: NCT03973632 Not yet recruiting - Healthy Volunteer Clinical Trials

Pharmacokinetic Study of SH-1028 Tablets in Healthy Subjects Under Fasting and Fed Conditions

Start date: July 2019
Phase: Phase 1
Study type: Interventional

To evaluate the food-effect of SH-1028 Tablets by pharmacokinetics in healthy subjects under fasting and fed conditions.

NCT ID: NCT03971825 Terminated - Healthy Volunteers Clinical Trials

A Safety Study of CC-92252 in Healthy Adult Subjects and Adult Subjects With Psoriasis

Start date: July 24, 2018
Phase: Phase 1
Study type: Interventional

This is a phase 1, randomized, single-center, 3-part, study to assess the safety, tolerability, PK, and PD, of single and multiple doses of CC-92252 in healthy adult subjects and multiple doses of CC-92252 in adult subjects with psoriasis.

NCT ID: NCT03970122 Completed - Healthy Volunteers Clinical Trials

FIH Ph 1 Study of TRPC5 Channel Inhibitor GFB-887 in Healthy Subjects

Start date: May 29, 2019
Phase: Phase 1
Study type: Interventional

The study will comprise primarily a single-ascending dose (SAD) escalation component.

NCT ID: NCT03969849 Completed - Healthy Volunteers Clinical Trials

Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants

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

The primary objective of the study is to evaluate the safety and tolerability of REGN5713-5714-5715 in healthy adult participants. The secondary objectives of the study are: In Part A and Part B: - To characterize the concentration time profile of single doses of REGN5713-5714-5715 in healthy adults - To assess the immunogenicity of single dose of REGN5713-5714-5715. In Part B: - To assess the inhibition of allergic symptoms as measured by total nasal symptom score (TNSS) provoked by a birch allergen nasal allergen challenge (NAC) in birch-sensitized allergic subjects after a single subcutaneous (SC) dose of REGN5713-5714-5715 - To assess the skin test reactivity provoked by a skin prick test (SPT) with serial birch allergen titration after a single SC dose of REGN5713-5714-5715.

NCT ID: NCT03965728 Completed - Healthy Volunteers Clinical Trials

Study to Investigate Safety, Tolerability, Pharmacokinetics, and Drug-drug Interaction of Multiple Oral Doses of BAY1830839 in Healthy Male Participants

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

The aim of this study is to investigate safety, tolerability and pharmacokinetics of increasing repeated oral doses of BAY1830839 in healthy male participants including the investigation of any potential drug-drug interactions of BAY1830839 with midazolam and methotrexate. In addition, the effects of BAY180839 on exploratory pharmacodynamics biomarkers in healthy participants will be investigated.