Status:
COMPLETED
A Two Part Phase 1, Repeated Doses and Continuous Infusion Study With ITF2984 in Healthy Volunteers
Lead Sponsor:
Italfarmaco
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an extended dosing regimen of ITF2984: part A, designed as double-blind, placebo-cont...
Detailed Description
This was a two part Phase I repeated incremental doses study in male healthy volunteers. The study was conducted in two parts. A total of 36 subjects was planned to be enrolled in Part A and 36 subjec...
Eligibility Criteria
Inclusion
- Healthy males
- Aged 18 to 55 y.o., inclusive, at the time of signing the informed consent
- Body Mass Index (BMI) of 18 to 25 kg/m2, inclusive
- Must be willing and able to communicate and participate in the whole study
- An understanding, ability and willingness to fully comply with study procedures and restrictions.
- Ability to provide written, personally signed and dated informed consent to participate in the study before completing any study-related procedures.
- Subject must be willing to comply with any applicable contraceptive requirements of the protocol
- Satisfactory medical assessment with no clinically significant or relevant abnormalities in the current medical conditions, physical examination, vital signs, ECG and laboratory evaluation as assessed by the Investigator
Exclusion
- Current or recurrent disease that could affect the action, absorption or disposition of the investigational medicinal product, or could affect clinical or laboratory assessments.
- Current or relevant previous history of physical or psychiatric illness that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the IMP or study procedures.
- History or presence at the moment of screening visit of gallstones.
- Significant illness, as judged by the Investigator, within 2 weeks of the first dose of IMP.
- Use of prescription or non-prescription drugs (other than 2 g per day paracetamol), including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- Known or suspected intolerance or hypersensitivity to the IMP, closely related compounds or any of the stated ingredients.
- History of regular alcohol consumption within 6 months of the study
- A positive pre-study drug/alcohol screen.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome).
- A positive test for HIV antibody.
- Current use of tobacco or other nicotine containing products in any form. Ex users must report that they have stopped using tobacco for at least 90 days prior to receiving the first dose of investigational medicinal product.
- A breath carbon monoxide reading of greater than 10 ppm at screening.
- Any condition that results in a whole blood loss greater than 500 mL within a 90 days period before study participation.
- The subject has participated in a clinical trial and has received an investigational product within the 6 months prior to the first dosing day in the current study(rescreening for subjects that does not have received the study drug during this study is allowed).
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the Investigator.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated
- Subjects fail to satisfy the Investigator of his fitness to participate in this study for any other reason.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01897844
Start Date
May 1 2013
End Date
December 1 2013
Last Update
April 9 2014
Active Locations (1)
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1
Centro Ricerche Cliniche
Verona, Verona, Italy, 37134