Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Reproductive Control Agents

Lenvatinib

Moxifloxacin

Norgestimate, ethinyl estradiol drug combination

Anti-Bacterial Agents

Enzyme Inhibitors

Protein Kinase Inhibitors

32 mg will be administered orally as three 4 mg and two 10 mg capsules as a single dose.

Moxifloxacin 400 mg will be administered orally as one 400 mg tablet.

Moxifloxacin 400 mg

The Placebo dose will consist of three 4 mg and two 10 mg placebo capsules.

Placebos (matched to 4 mg and 10 mg lenvatinib capsules).

Robert Shumaker

This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled, three-treatment, three-way crossover study in healthy subjects. There are two phases in this study: Pre-Randomization and Randomization. The Pre-Randomization Phase consists of Screening and Baseline Period 1. The Randomization Phase consists of five periods: Treatment Period 1, Baseline Period 2, Treatment Period 2, Baseline Period 3, and Treatment Period 3. Completion of study termination procedures will be performed at Visit 11.

A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval

Eisai Inc.

Symptoms and General Pathology

Neoplasm Metastasis

Hematinics

Liver Extracts

2 Patients were included as controls- no MXF given

The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection.

Martin K Schilling, MD

The aim of the study is to provide data on the pharmacokinetics (PK) of moxifloxacin (MXF) in serum and liver tissue of patients undergoing liver resection due to primary or secondary tumor of the liver.

After given informed consent, patients scheduled for planned liver resection are enrolled into the study. The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection. Blood and healthy liver tissue are sampled in 34 patients after administration of MXF. Plasma is sampled concomitantly. In a subgroup of 19 patients, additional serum specimens are obtained after 2, 4, 8, 12, 24, 36 and 48 h to establish the PK. The pharmacokinetic parameters of MXF are calculated applying a two-compartment model.

Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection.

Study on Pharmacokinetics of Moxifloxacin in Serum and Liver Tissue of Patients Undergoing Liver Resection Due to Primary or Secondary Tumor of the Liver

The first outcome of this study was to analyze the concentration of MFX in liver tissue of patients who received MFX 400 mg i.v..

The maximum concentration (mg/L) of moxifloxacin in the serum of patients who received 400 mg moxifloxacin was measured at the end of the intravenous infusion.

The number of participants and kind of adverse events were recorded up to 48 hours after intravenous infusion of 400 mg moxifloxacin.

The serum concentration of moxifloxacin was measured at different time points (2, 3, 4, 6, 8, 12, 24, 36 hour after infusion) up to 48 hours after intravenous infusion of 400 mg moxifloxacin.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval	NCT01525394	Refractory Soli... Lymphomas	Lenvatinib Moxifloxacin 40... Placebos (match...	18 Years -	Eisai Inc.
Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection.	NCT01302951	Side-effect of ...	Moxifloxacin 40...	18 Years - 80 Years	University Hospital, Saarland
Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection.	NCT01302951	Side-effect of ...	Moxifloxacin 40...	18 Years - 80 Years	University Hospital, Saarland

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