HealthyPhase 114 days MADNCT01897844
A Two Part Phase 1, Repeated Doses and Continuous Infusion Study With ITF2984 in Healthy Volunteers
A Phase 1 study testing ITF2984 (100, 2000, 3000 mcg bid) in people with Healthy, run by Italfarmaco at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ITF2984 (100, 2000, 3000 mcg bid)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-part Phase I Study in Male Healthy Volunteers to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Repeated Incremental Doses of ITF2984. Part A is Double-Blind, Randomized, Subcutaneous Administration. Part B is Open Label, Continuous Infusion.
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.
Read the 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 subjects in Part B. Part A was performed according to a double blind, randomized, placebo controlled design and included three sequential dose groups of repeat doses. Each group enrolled 12 subjects on ITF2984 or placebo (ratio 9 active: 3 placebo) and received ITF2984 s.c. or placebo twice daily for 14 days. For all three groups the last dose was planned to be the first dose on Day 14.
The study started with the Group 1 2000mcg s.c. b.i.d., Group 2 received 3000mcg b.i.d. after an interim review of the safety and PK data of the 2000mcg dose level. Group 3 received 100mcg s.c. to gather data to complete the PK/PD profile of ITF2984. Subjects were screened up to 28 days before dosing with ITF2984/placebo that took place on Days 1-14.
For all Groups, on day -1 and day 13 subjects received the exogenous tests administration (GHRH, Arginin and TRH) 30 minutes after the first morning administration of ITF2984/placebo.
Part B was open label, and planned for six sequential dose groups of 6 subjects each. In each group subjects received ITF2984 continuous subcutaneous infusion for 7 consecutive days. The dose was escalated, from the starting dose of 900 mcg, by a maximum of three fold or more cautiously, if deemed necessary. The decision to test higher dose levels was based on review of safety and PK data from the previous dose level(s). After a 28 day screening period, subjects were admitted to the clinical unit on the evening of day -2. ITF2984 continuous infusion planned from day 1 to day 8 in the morning. On day -1 (the day prior to the start of infusion) subjects received the exogenous/challenge test administrations (GH-RH+Arginina and TRH). On day 7 the challenge tests were repeated.
- Conditions
- Healthy
- Being tested
- ITF2984 (100, 2000, 3000 mcg bid), Placebo
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITF2984 (100, 2000, 3000 mcg bid)Drug
Also called somatostatin analogues
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ITF2984/Placebo 2000 mcg sc bid | Experimental | ITF2984/Placebo 2000mcg s.c. b.i.d. for 14 days Receives: 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 Receives: 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 Receives: Drug: ITF2984 (100, 2000, 3000 mcg bid); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
To investigate the pharmacokinetics (PK) profile of multiple ascending doses of ITF2984
Plasma concentrations of ITF2984
Measured: 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.
Measured: 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
PD biomarkers of GH
Measured: 13 Days and 7 Days
To investigate the effects of ITF2984 on thyroid stimulating hormone (TSH) after exogenous thyrotrophin releasing hormone (TRH) stimulus
PD biomarkers of TSH
Measured: 13 days and 7 days
To investigate the effects of ITF2984 on IGF-1
PD biomarkers of IGF-1
Measured: 13 days and 7 days
To investigate the effects of ITF2984 on glucose
PD biomarkers of glucose
Measured: 14 days and 6 days
To investigate the effects of ITF2984 on prolactin (PRL) after exogenous thyrotrophin releasing hormone (TRH) stimulus
PD biomarkers of PRL
Measured: 13 days and 7 days
To investigate the effects of ITF2984 on insulin
PD biomarkers of insulin
Measured: 14 days and 6 days
To investigate the effects of ITF2984 on glucagon
PD biomarkers of glucagon
Measured: 14 days and 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italfarmaco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luigi Ziviani, MD, Principal investigator, Centro Ricerche Cliniche Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897844
- Sponsor's protocol ID
- DSC/13/2984/03
- Other IDs
- 2013-001076-38
- Acronym
- 14 days MAD
- Status last verified
- Apr 2014
- First submitted
- 3 Jul 2013
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Phase I Study in Male Healthy Volunteers to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Repeated Incremental Doses of ITF2984. Part A is Double-Blind, Randomized, Subcutaneous Administration. Part B is Open Label, Continuous Infusion.
- ClinicalTrials.gov ID
- NCT01897844
- Acronym / sponsor ID
- 14 days MAD / DSC/13/2984/03
- Conditions
- Healthy
- Keywords
- volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ItalfarmacoIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 subjects in Part B. Part A was performed according to a double blind, randomized, placebo controlled design and included three sequential dose groups of repeat doses. Each group enrolled 12 subjects on ITF2984 or placebo (ratio 9 active: 3 placebo) and received ITF2984 s.c. or placebo twice daily for 14 days. For all three groups the last dose was planned to be the first dose on Day 14.
The study started with the Group 1 2000mcg s.c. b.i.d., Group 2 received 3000mcg b.i.d. after an interim review of the safety and PK data of the 2000mcg dose level. Group 3 received 100mcg s.c. to gather data to complete the PK/PD profile of ITF2984. Subjects were screened up to 28 days before dosing with ITF2984/placebo that took place on Days 1-14.
For all Groups, on day -1 and day 13 subjects received the exogenous tests administration (GHRH, Arginin and TRH) 30 minutes after the first morning administration of ITF2984/placebo.
Part B was open label, and planned for six sequential dose groups of 6 subjects each. In each group subjects received ITF2984 continuous subcutaneous infusion for 7 consecutive days. The dose was escalated, from the starting dose of 900 mcg, by a maximum of three fold or more cautiously, if deemed necessary. The decision to test higher dose levels was based on review of safety and PK data from the previous dose level(s). After a 28 day screening period, subjects were admitted to the clinical unit on the evening of day -2. ITF2984 continuous infusion planned from day 1 to day 8 in the morning. On day -1 (the day prior to the start of infusion) subjects received the exogenous/challenge test administrations (GH-RH+Arginina and TRH). On day 7 the challenge tests were repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ITF2984/Placebo 2000 mcg sc bid | Experimental | Drug: ITF2984 (100, 2000, 3000 mcg bid), Drug: PlaceboITF2984/Placebo 2000mcg s.c. b.i.d. for 14 days |
| ITF2984/Placebo 3000 mcg sc bid | Experimental | Drug: ITF2984 (100, 2000, 3000 mcg bid), Drug: PlaceboITF2984/Placebo 3000mcg s.c. b.i.d. for 14 days |
| ITF2984/Placebo 100 mcg sc bid | Experimental | Drug: ITF2984 (100, 2000, 3000 mcg bid), Drug: PlaceboITF2984/Placebo 100mcg s.c. b.i.d. for 14 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITF2984 (100, 2000, 3000 mcg bid)Also: somatostatin analogues | Drug | 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 |
Primary outcome
To investigate the safety profile of repeated doses of ITF2984
Time frame: 15 days
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.
To investigate the pharmacokinetics (PK) profile of multiple ascending doses of ITF2984
Time frame: 15 days and day 8
Plasma concentrations of ITF2984
To investigate the safety profile of repeated doses of ITF2984
Time frame: 8 days
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.
7 secondary outcomes
To investigate the effects of ITF2984 on growth hormone (GH) after exogenous growth hormone releasing hormone (GH-RH) and arginine stimulus
Time frame: 13 Days and 7 Days
To investigate the effects of ITF2984 on thyroid stimulating hormone (TSH) after exogenous thyrotrophin releasing hormone (TRH) stimulus
Time frame: 13 days and 7 days
To investigate the effects of ITF2984 on IGF-1
Time frame: 13 days and 7 days
To investigate the effects of ITF2984 on glucose
Time frame: 14 days and 6 days
To investigate the effects of ITF2984 on prolactin (PRL) after exogenous thyrotrophin releasing hormone (TRH) stimulus
Time frame: 13 days and 7 days
To investigate the effects of ITF2984 on insulin
Time frame: 14 days and 6 days
To investigate the effects of ITF2984 on glucagon
Time frame: 14 days and 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Ziviani, MD principal investigator
Centro Ricerche Cliniche Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ITF2984 (100, 2000, 3000 mcg bid) in people with Healthy, run by Italfarmaco at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the safety profile of repeated doses of ITF2984 (time frame: 15 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.