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NCT ID: NCT04676906 Completed - Healthy Volunteers Clinical Trials

A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study Compounds

Start date: November 26, 2020
Phase: Phase 1
Study type: Interventional

People with type 2 diabetes have too much sugar in their blood and need treatment to control their sugar level. The 3 study compounds in this study are similar to an approved antidiabetic medicine that helps to lower blood sugar levels in people with type 2 diabetes. This approved antidiabetic medicine is generally safe and well tolerated. The study compounds are expected to have the same antidiabetic effect as the approved medicine. The purpose of this study is to investigate how quickly and to what extent each of the 3 study compounds are broken down in the body (this is called pharmacokinetics). The dose of each study compound will be very low (this is called a microdose), and will be labelled with a small amount of carbon-14. This is radioactive, and it makes it possible to track the study compound in the blood. The 3 study compounds in this study have not been given to humans before. The study will be performed in up to 18 healthy male volunteers. The study will consist of 3 groups of 6 volunteers each. Each participant will receive only one dose of study medicine.

NCT ID: NCT04676763 Completed - Skin Diseases Clinical Trials

Substance P Challenge in Healthy Participants

Start date: March 2, 2021
Phase: N/A
Study type: Interventional

The objectives of this enabling study are to characterize the wheal and flare responses over time following skin challenges with ascending concentrations of Substance P. This will be a 2-part study: Part 1 will aid in the understanding of the wheal and flare responses following Substance P. Part 2 will investigate the variability of the responses. Participants may be enrolled into Part 1 or Part 2, not both.

NCT ID: NCT04674761 Completed - Alagille Syndrome Clinical Trials

Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome

ASSERT
Start date: March 19, 2021
Phase: Phase 3
Study type: Interventional

Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.

NCT ID: NCT04673825 Completed - Psoriatic Arthritis Clinical Trials

Monitoring Spondyloarthritis With SpA-Net

TeleSpA
Start date: December 2, 2020
Phase: N/A
Study type: Interventional

Randomized controlled trial to assess the effectiveness and cost-effectiveness of an intervention combining patient initiated care and telemonitoring through the online eHealth platform SpA-Net versus standard care for patients with spondyloarthritis.

NCT ID: NCT04672954 Completed - Healthy Clinical Trials

A Study in Healthy Men to Test How Different Doses of BI 474121 Are Taken up and How They Influence the Amount of a Molecular Messenger (cGMP) in the Spinal Fluid

Start date: January 7, 2021
Phase: Phase 1
Study type: Interventional

The main objectives of this trial are: - To evaluate the effect of BI 474121 on cyclic guanosine monophosphate (cGMP) levels in cerebrospinal fluid (CSF) - To assess the exposure of BI 474121 in CSF relative to plasma - To determine the exposure effect relationship in CSF with different oral doses of BI 474121

NCT ID: NCT04672226 Completed - Clinical trials for Pyridoxine Dependant Epilepsy

Evaluation of PDE MAX

PDE MAX
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

PDE MAX is a single arm prospective, feasibility study in up to 15 participants aged one (1) year and over of PDE MAX for the dietary management of Pyridoxine Dependent Epilepsy.

NCT ID: NCT04670471 Completed - Anesthesia Clinical Trials

Assessment of the Pharmacodynamic and Pharmacokinetic Interaction of Remimazolam and Remifentanil

Start date: April 13, 2021
Phase: Phase 1
Study type: Interventional

This trial is designed to quantify the pharmacodynamic (PD) and pharmacokinetic (PK) interaction(s) between an anaesthetic drug (remimazolam) and an opioid (remifentanil). Remimazolam is a new anaesthetic drug with a sedative effect, which, in combination with an opioid can be used to achieve general anaesthesia. To date, however, no clinical trials have been conducted to specifically assess the potential for drug-drug interactions between remimazolam and remifentanil. Greater understanding of the potential for such interactions will help define more appropriate dosing regimens with less over-sedation and associated side effects.

NCT ID: NCT04670432 Completed - Clinical trials for Deep Vein Thrombosis

Resolution Enhancement by a Supplemental Obstruction Lessening Venoactive Drug for Eight Weeks in Deep Vein Thrombosis

Resolve-DVT
Start date: December 8, 2020
Phase: Phase 3
Study type: Interventional

The RESOLVE-DVT study is a randomized single-center pilot study to determine the effects of hydroxyethylrutoside (Venoruton) on aspects of deep vein thrombosis (DVT) resolution associated with post-thrombotic syndrome (PTS). Based on these results, the investigators will estimate its potential as a preventive therapy for PTS. Eligible consenting patients who develop an acute, objectively confirmed DVT will be randomized and equally allocated to two trial arms, either the treatment group (Venoruton tablet 500 mg twice daily) or the control group (usual care). The pilot trial consists of 5 study contacts over 12 weeks at which outcome assessment is performed: inclusion, 1 week, 4 weeks, 8 weeks, 12 weeks. Treatment allocation is masked for outcome assessors, but not for patients.

NCT ID: NCT04669600 Completed - Clinical trials for Immune Thrombocytopenia (ITP)

A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)

Start date: February 4, 2021
Phase: Phase 2
Study type: Interventional

Primary Objective: - To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistent/chronic immune thrombocytopenia (ITP) Secondary Objectives: - To assess the safety and tolerability of BIVV020 - To assess the pharmacokinetics of BIVV020 - To assess the response rate of treatment with BIVV020 - To assess the time to response - To assess the effect of treatment with BIVV020 on the requirement for rescue ITP therapy - To assess the immunogenicity of BIVV020

NCT ID: NCT04667377 Completed - Obesity Clinical Trials

A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

Start date: March 8, 2021
Phase: Phase 2
Study type: Interventional

This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight. Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine. Participants are in the study for about a year. During this time, there are about 20 in-person visits to the study site. At the study site visits, doctors measure participants' body weight. Results are compared between the BI 456906 groups and the placebo group. The doctors also regularly check the general health of the participants.