A Two Part Phase 1, Repeated Doses and Continuous Infusion Study With ITF2984 in Healthy Volunteers

NCT01897844 | Completed Phase 1

• 2 other identifiers: DSC/13/2984/032013-001076-38
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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-controlled, randomized, tested an extended dosing regimen, i.e. 14 consecutive dosing days and higher doses, i.e. up to 6000 mcg/day and in part B, open label, continuous subcutaneous infusion for 7 days were tested as ascending doses of ITF2984 up to 9000 mcg/day of ITF2984.

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (3)

• To investigate the safety profile of repeated doses of ITF2984

  Adverse events; 12-lead ECG, including QTc; vital signs (blood pressure, heart rate and body temperature); clinical laboratory evaluations (haematology, clinical chemistry including peripheral glucose, urinalysis), gallbladder volume evaluation.

  15 days

• To investigate the pharmacokinetics (PK) profile of multiple ascending doses of ITF2984

  Plasma concentrations of ITF2984

  15 days and day 8

• To investigate the safety profile of repeated doses of ITF2984

  Adverse events; 12-lead ECG, including QTc; vital signs (blood pressure, heart rate and body temperature); clinical laboratory evaluations (haematology, clinical chemistry including peripheral glucose, urinalysis.

  8 days

Secondary Outcomes (7)

• To investigate the effects of ITF2984 on growth hormone (GH) after exogenous growth hormone releasing hormone (GH-RH) and arginine stimulus

  13 Days and 7 Days

• To investigate the effects of ITF2984 on thyroid stimulating hormone (TSH) after exogenous thyrotrophin releasing hormone (TRH) stimulus

  13 days and 7 days

• To investigate the effects of ITF2984 on IGF-1

  13 days and 7 days

• To investigate the effects of ITF2984 on glucose

  14 days and 6 days

• To investigate the effects of ITF2984 on prolactin (PRL) after exogenous thyrotrophin releasing hormone (TRH) stimulus

  13 days and 7 days

Study Arms (3)

ITF2984/Placebo 2000 mcg sc bid

EXPERIMENTAL

ITF2984/Placebo 2000mcg s.c. b.i.d. for 14 days

Drug: ITF2984 (100, 2000, 3000 mcg bid); Drug: Placebo

ITF2984/Placebo 3000 mcg sc bid

EXPERIMENTAL

ITF2984/Placebo 3000mcg s.c. b.i.d. for 14 days

Drug: ITF2984 (100, 2000, 3000 mcg bid); Drug: Placebo

ITF2984/Placebo 100 mcg sc bid

EXPERIMENTAL

ITF2984/Placebo 100mcg s.c. b.i.d. for 14 days

Drug: ITF2984 (100, 2000, 3000 mcg bid); Drug: Placebo

Interventions

ITF2984 (100, 2000, 3000 mcg bid) DRUG

Also known as: somatostatin analogues

ITF2984/Placebo 100 mcg sc bid; ITF2984/Placebo 2000 mcg sc bid; ITF2984/Placebo 3000 mcg sc bid

Placebo DRUG

ITF2984/Placebo 100 mcg sc bid; ITF2984/Placebo 2000 mcg sc bid; ITF2984/Placebo 3000 mcg sc bid

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Italfarmaco: lead

Study Sites (1)

Centro Ricerche Cliniche

Verona, Verona, 37134, Italy

Location

MeSH Terms

Interventions

BID protein, human

Study Officials

• Luigi Ziviani, MD

  Centro Ricerche Cliniche Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 12, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

IT (1)