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Healthy Volunteers clinical trials

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NCT ID: NCT03004404 Completed - Healthy Volunteers Clinical Trials

To Assess Safety, Tolerability and Pharmacokinetics of BI 730357 in Healthy Male Volunteers

Start date: January 12, 2017
Phase: Phase 1
Study type: Interventional

The primary objective of the Single Rising Dose (SRD) part (trial part 1) is to investigate the safety and tolerability of BI 730357 in healthy subjects following oral administration of single rising doses after fasting and/or non-fasting conditions. The secondary objective is the exploration of the pharmacokinetics (PK) including dose proportionality, and pharmacodynamics of BI 730357 after single dosing. The objective of the Bioavailability (BA) part (trial part 2) will be to explore the relative bioavailability of tablet fasted versus oral solution fasted and the influence of food on the bioavailability of tablet fasted versus tablet fed.

NCT ID: NCT03001297 Completed - Healthy Volunteers Clinical Trials

Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884

Start date: January 17, 2017
Phase: Phase 1
Study type: Interventional

A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in healthy volunteers

NCT ID: NCT02999620 Completed - Healthy Volunteers Clinical Trials

FBCx (Alpha-CD) Mechanism of Action Trial

FMAT
Start date: January 2017
Phase: N/A
Study type: Interventional

To determine the fat losses in stool associated with alpha-CD use in healthy volunteers, as compared to placebo when consumed with a standardized radiolabeled fatty meal.

NCT ID: NCT02999191 Completed - Healthy Volunteers Clinical Trials

Relative Bioavailability of BI 1467335 Tablet and Oral Solution, and Food Effect on Tablet in Healthy Male Subjects

Start date: January 10, 2017
Phase: Phase 1
Study type: Interventional

The primary objective of this trial is to investigate the relative bioavailability of BI 1467335, given as film-coated tablet compared to BI 1467335, given as oral solution. This assessment will be performed under fasted conditions. Furthermore, the effect of food on relative bioavailability of the tablet formulation of BI 1467335 will be investigated.

NCT ID: NCT02998190 Completed - Healthy Volunteers Clinical Trials

First-in-Human Single and Multiple Dose of EB8018

Start date: November 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety profile of single and multiple doses of EB8018 in healthy male subjects, to determine the pharmacokinetic profile of single and multiple doses of EB8018 in healthy male subjects and to assess preliminary effects of EB8018 on the healthy male gut microbiome.

NCT ID: NCT02996084 Completed - Healthy Volunteer Clinical Trials

MS PATHS Normative Sub-Study

Start date: December 12, 2017
Phase:
Study type: Observational

The primary objective of this study is to determine the normative range of brain volume and brain volume change in healthy control (HC) participants whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use the results of the primary endpoint to ensure consistency of brain volume measurements across MS PATHS centers.

NCT ID: NCT02996019 Completed - Healthy Volunteers Clinical Trials

A Study to Compare Pharmacokinetics (PK) of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD) or an Auto-injector (AI)

Start date: December 7, 2016
Phase: Phase 1
Study type: Interventional

This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to compare the PK of etrolizumab administered subcutaneously by an AI (test device) or a PFS-NSD (reference device) in healthy participants. The study will comprise a pilot cohort (Part 1) to estimate the geometric mean ratio (GMR) and variability of the maximum observed concentration (Cmax) and area under the concentration-time curve (AUC) to confirm or determine the sample size for the pivotal cohort (Part 2). The pivotal cohort will demonstrate exposure comparability of Cmax, AUC from Hour 0 to the last measurable concentration (AUClast), and AUC from Hour 0 to extrapolated infinite time (AUC0-inf), values for a single dose of etrolizumab administered subcutaneously either by the AI or the PFS-NSD.

NCT ID: NCT02994381 Completed - Healthy Volunteers Clinical Trials

A Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults

Start date: October 2016
Phase: Phase 1
Study type: Interventional

This will be an open-label, non-randomized, single oral dose study in healthy male subjects. All subjects will receive a single oral dose of 10 mL of [14C]-RPC1063 Solution (0.1 mg/mL), containing NMT 1.3 MBq (37 μCi) 14C.

NCT ID: NCT02991508 Completed - Healthy Volunteers Clinical Trials

Adrecizumab Phase 1 Trial

Start date: May 23, 2016
Phase: Phase 1
Study type: Interventional

This is the first clinical trial with ADRECIZUMAB. The purpose of this clinical trial to identify safety and tolerability of different doses of ADRECIZUMAB in healthy volunteers.

NCT ID: NCT02984150 Completed - Healthy Volunteers Clinical Trials

Effect of Intragastric Administration of Fatty Acids on Generalized Reward Sensitivity

Start date: November 2014
Phase: N/A
Study type: Interventional

This study aim to investigate the influence of intragastrically infused fatty acid on the generalization of responses to reward within the food domain and between financial and sexual domains.