Clinical Trials Logo
  1. Home
  2. No Condition
  3. NCT04803396

Ascending Dose Tolerability Trial and PK Assessment in Healthy Volunteers After Single & Multiple Oral Intake of DF2755A

no Condition Clinical Trial

Official title:
An Ascending Dose Tolerability Study and Pharmacokinetic Assessment in Healthy Male and Female Volunteers After Single & Multiple Oral Administration of DF2755A

Clinical Trial Summary

Primary objective: •To evaluate the tolerability and safety of ascending single doses of DF2755A in healthy adultmale and female volunteers. Secondary Objectives: - To determine the pharmacokinetics parameters of DF2755A - To establish a dose concentration-response relationship over a wide range of doses in order toselect a narrower range of dose and dosing regimen to be subsequently studied in patients aftersingle administration - To evaluate the effect of ascending single doses on the pharmacodynamics parameters - To compare metabolites pathway in Human with the one observed in animals

Clinical Trial Description

The study is a phase I, single center, double-blind, placebo controlled, randomized, ascending single doses study in healthy male and female volunteers. The design consists of a double blind comparison of the test compound versus placebo in which the dose is increased in successive treatment periods. Dose was escalated in order to achieve enough safety information on an interval of doses possibly encompassing both the effective dose and the maximum tolerated dose (defined as the highest dose devoid of any clinical signs/symptoms). The study has been terminated after Part A (single ascending doses) so the methodology was revised accordingly. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04803396
Study type Interventional
Source Dompé Farmaceutici S.p.A
Contact
Status Completed
Phase Phase 1
Start date November 15, 2018
Completion date March 13, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT02265224 - Bioequivalence Study of Two Different Formulations of N-acetyl-cysteine (NAC) Phase 1
Completed NCT00379210 - Neural Effects of Mindfulness Training on Attention N/A
Completed NCT05901220 - Joint School-Health Project of the Neapolitan Child N/A
Active, not recruiting NCT04455295 - Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation N/A
Not yet recruiting NCT03225638 - Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®) N/A
Completed NCT04854642 - A Single Dose Study About the Influence of Food on the Oral Bioavailability of Ladarixin Capsule in Healthy Volunteers Phase 1
Recruiting NCT03134482 - Comparison of Clinical Outcomes Between IVM and Minimal Stimulation IVF in Patients With PCOS N/A
Recruiting NCT05882942 - Matcha Green Tea Effects at Rest and During Moderate-intensity Exercise in Females N/A
Completed NCT03044301 - Performance Thresholds Evaluation by Wet Injection Quantification and Magnetic Resonance Imaging (MRI) of Subcutaneous and Intramuscular Injections (0,65ml) of Several Configurations of Needle-free Devices (ZENEO®) N/A
Completed NCT01563224 - GABA-B Receptor Function in Healthy Volunteers N/A
Terminated NCT04227405 - TOGETHER: A Couple's Model to Enhance Relationships and Economic Stability N/A
Completed NCT04802967 - A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males Phase 1