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

NCT04803396 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-04-26

Study results available
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Summary

Primary objective:

•To evaluate the tolerability and safety of ascending single doses of DF2755A in healthy adult male 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 to select a narrower range of dose and dosing regimen to be subsequently studied in patients after single 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

Please note that the study has been closed after Part A (single ascending doses), so all the objectives were revised accordingly.

Conditions

  • no Condition

Interventions

DRUG

DF2755A

DF2755A was planned to be administered in two different parts: Part A: Single oral dose administration on D1 according to the randomization (50, 150, 300 and 300 mg oad). Part B: was planned (100 mg bid, 200 mg bid or 300 mg bid) but not performed (repeated oral administration from Day 1 to Day 14).

OTHER

Placebo

Single oral dose administration on D1

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Yves Donazzolo, MD, MSc · Eurofins Optimed

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2019-06-29
Completion
2019-06-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04803396 on ClinicalTrials.gov