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Healthy Volunteers clinical trials

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NCT ID: NCT04241458 Completed - Healthy Volunteers Clinical Trials

A Study to Test How Well Healthy Men and Women Tolerate Different Doses of BI 706321

Start date: January 30, 2020
Phase: Phase 1
Study type: Interventional

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 706321 in healthy male and female subjects following oral administration of multiple rising doses for 14 days.

NCT ID: NCT04240223 Completed - Healthy Volunteers Clinical Trials

A Study to Investigate the Use of Delayed Release Tablets for Colonic Delivery of Brilacidin in Healthy Volunteers

Start date: January 6, 2020
Phase: Phase 1
Study type: Interventional

This is a single-centre, blinded, randomized, placebo controlled, dose escalation study. Up to 9 healthy male volunteers will participate in the study. This study is designed to investigate the use of delayed release tablets for colonic delivery of Brilacidin.

NCT ID: NCT04238663 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers

Start date: September 24, 2019
Phase: Phase 1
Study type: Interventional

Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the pharmacokinetics (PK), safety and immunogenicity profile of MB02 with US and EU Avastin® in healthy male 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: NCT04238650 Completed - Healthy Volunteers Clinical Trials

A Pharmacokinetic Study Comparing MB02 And EU Avastin® In Healthy Male Volunteers

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

A Randomised, Double Blind, Two-Arm, Single Dose, Parallel Phase I Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (a Proposed Bevacizumab Biosimilar Drug) and EU Approved Avastin® in Japanese Healthy Male Volunteers. 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: NCT04238364 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability and Amount of EI-1071 in Blood in Healthy Volunteers

Start date: December 27, 2019
Phase: Phase 1
Study type: Interventional

This was a first-in-human study to determine the safety, tolerability, and pharmacokinetics of EI1071 after single and multiple doses in healthy volunteers.

NCT ID: NCT04236778 Completed - Healthy Volunteers Clinical Trials

First-in-human Study of VE303 in Healthy Adult Volunteers

Start date: November 28, 2017
Phase: Phase 1
Study type: Interventional

This study was designed to evaluate safety and tolerability of a range of doses of VE303 in healthy adult volunteers. The study also evaluated pharmacokinetics of intestinal colonization by the VE303 strains and pharmacodynamics of recovery of the gut microbiota after administration of antibiotics followed by a course of VE303.

NCT ID: NCT04234672 Completed - Healthy Volunteers Clinical Trials

A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants

Start date: February 17, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-831 and a single oral administration of 500 milligram (mg) TAK-831 tablets in Period 1, and to assess the mass balance, characterize the PK of TAK-831 in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral suspension dose of 500 mg (approximately 100 μCi) [14C]TAK-831 in Period 2.

NCT ID: NCT04231513 Completed - Healthy Volunteers Clinical Trials

A Study to Assess Safety, Tolerability, Pharmacokinetics (PK), Immunogenicity, and Pharmacodynamics (PD) of Intravenous Infusions of E2814 in Healthy Participants

Start date: December 16, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of single and multiple intravenous infusions of E2814 in healthy adult participants.

NCT ID: NCT04231435 Completed - Healthy Volunteers Clinical Trials

Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin

Start date: December 18, 2019
Phase: Phase 1
Study type: Interventional

This is a nonrandomized, fixed-sequence, open-label study to evaluate the effect of a single dose of fedratinib on the PK, safety, and tolerability of single doses of digoxin, rosuvastatin, and metformin in healthy subjects. The subjects will participate as follows: - Screening phase - Treatment phase (includes baseline) - Follow-up telephone call Subjects will be screened for eligibility during the screening phase. Subjects who meet all inclusion criteria and none of the exclusion criteria will return to the clinical site on Day -1 for protocol-specified assessments, and will be domiciled at the clinical site from Day -1 through the morning of Day 22. During the study, blood samples will be collected at prespecified times for PK and PD. Urine samples will be collected at prespecified times for urinary PK evaluation of metformin. Subject safety will be monitored throughout the study.

NCT ID: NCT04228354 Completed - Obesity Clinical Trials

A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide

Start date: January 29, 2020
Phase: Phase 1
Study type: Interventional

The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions. Participants will get both versions of semaglutide. The order in which participants receive the versions is decided by chance. Participants will get the medicines as an injection under the skin of the belly with the use of a pen-injector. The study will last for about 11 to 17 weeks. Participants will have 27 visits with the study doctor. At 2 visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.