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Healthy Volunteers clinical trials

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NCT ID: NCT04147715 Completed - Healthy Volunteer Clinical Trials

Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults

Start date: October 9, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of Part 1 of the study is to evaluate the safety and tolerability of S-648414 after administration of a single oral dose of S-648414 in healthy adult study participants. The primary objective of Part 2 is to evaluate the safety and tolerability of S-648414 after administration of multiple oral doses of S-648414 in healthy adult study participants. The primary objectives of Part 3 are evaluate the safety and tolerability of S-648414 after administration of multiple oral doses of S-648414 in healthy adult study participants, and to evaluate the effect of S-648414 on the pharmacokinetics (PK) of dolutegravir and the effect of dolutegravir on the PK of S-648414 in healthy adult study participants.

NCT ID: NCT04147572 Completed - COPD Clinical Trials

Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler

TIOPIF
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

The study will characterise inspiratory flow parameters across placebo dry powder inhaler Easyhaler (2 inhaler versions) and placebo Spiriva inhalation powder capsule inhaled via HandiHaler in patients with chronic obstructive pulmonary disease (COPD) and in healthy volunteers. Substudy: Easyhaler® and HandiHaler® Usability study in patients with COPD; to assess patients acceptability, preference, correct use and ability to learn to use Easyhaler and HandiHaler (with capsules) and to compare PIF rate via In-Check Dial meter with the PIF rate via spirometer in the main study.

NCT ID: NCT04145128 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate AG-881 in Healthy Japanese and Non-Asian Participants

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

The purpose of this study is to compare the pharmacokinetics (PK) and safety of AG-881 in healthy Japanese and Non-Asian participants after single oral doses of 10 mg and 50 mg of AG-881.

NCT ID: NCT04144374 Completed - Diabetes Clinical Trials

Omadacycline Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

Start date: February 10, 2020
Phase: Phase 1
Study type: Interventional

This study will determine the tissue penetration of the novel tetracycline antibiotic, omadacycline (Nuzyra, Paratek Pharmaceuticals, Inc.), into the extracellular, interstitial fluid of soft tissue in diabetic patients with lower limb wound infections. Penetration will be compared with a group of healthy volunteer control participants.

NCT ID: NCT04143945 Completed - Clinical trials for Healthy Volunteers Obesity

A Study Comparing the Injection Site Pain Experience After the Injection of Semaglutide B and Semaglutide D With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity

Start date: October 28, 2019
Phase: Phase 2
Study type: Interventional

This study in healthy men and women looks at the injection site experience of the DV3396 pen to that of the PDS290 pens when both pens are used to deliver 0.25 mg semaglutide subcutaneously (s.c., under the skin). Participants will receive 2 single doses of semaglutide 0.25 mg on 1 day. The 2 injections will be given at least 30 minutes apart, one in each side of the stomach. Participants will be in the clinic research center for 1 day. A follow-up phone call will take place between 4 and 5 weeks after the injections were given.

NCT ID: NCT04143477 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Pharmacokinetics and Safety of ASP015K in Healthy Chinese Subjects

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

The purpose of this study is to evaluate the pharmacokinetics and safety of ASP015K after single-dose and multiple-dose administration in healthy Chinese participants.

NCT ID: NCT04143061 Completed - Clinical trials for Healthy Volunteers (Meningococcal Infection)

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa

MET55
Start date: December 30, 2019
Phase: Phase 3
Study type: Interventional

This will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adults, adolescents, children, and toddlers in India and a modified double-blind, randomized, parallel-group, active-controlled, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adolescents and children in the Republic of South Africa (RSA).

NCT ID: NCT04141150 Active, not recruiting - Healthy Volunteers Clinical Trials

Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients Compared With Healthy Subjects

Start date: March 22, 2022
Phase: Phase 2
Study type: Interventional

The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MDAD, subjects with AD dementia, and healthy subjects.

NCT ID: NCT04139226 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of a New Spray Dried Dispersion (SDD) Formulation of CC-11050 After Single Dose of CC-11050 and to Evaluate the Pharmacokinetics of CC-11050 Under Fasted and Fed Conditions and After Coadministration With Omeprazole

Start date: August 28, 2019
Phase: Phase 1
Study type: Interventional

This is a two-part study to be conducted at single study center, (additional center(s) may be selected if needed) to assess the safety, tolerability, PK and PD parameters for a new SDD formulation of CC-11050 in healthy subjects. The effects of a high-fat meal and omeprazole will also be assessed. Blood samples will be collected at prespecified times for PK, clinical laboratory safety assessments, PD (Part 1 only), and/or exploratory analyses. Safety will be monitored throughout the study from the time the ICF is signed through study completion.

NCT ID: NCT04138043 Completed - Healthy Volunteers Clinical Trials

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese Participants

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

This is a randomized, double-blind (sponsor-open), placebo-controlled, single-center study involving Japanese participants. The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity after a single subcutaneous (SC) dose of GSK2330811 in healthy Japanese participants. GSK2330811 is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that binds and inhibits the action of Oncostatin M (OSM) and is being developed for the treatment of Crohn's disease (CD) and Systemic sclerosis (SSc). Participants will be randomized to receive either GSK2330811 (450 milligram [mg]) or placebo in an approximate ratio of 7:3.