Healthy Male VolunteersPhase 1MADNCT01871844
ITF2984 Repeated Doses Study in Healthy Volunteers
A Phase 1 study testing ITF2984 (500, 1000, 2000 mcg bid for 7 days) and octreotide 50 mcg tid in people with Healthy Male Volunteers, run by Italfarmaco at 2 sites in 2 countries.
Trial summary
This was a within group, randomised, repeated dose, placebo- and octreotide controlled study in a target population of 45 healthy male subjects. Subjects were required to attend the clinical for screening procedures between 3 and 28 days before dosing commenced. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- ITF2984 (500, 1000, 2000 mcg bid for 7 days) and octreotide 50 mcg tid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2012to May 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Caucasian male volunteers between 18 and 50 years of age, inclusive.
- Body mass index (BMI) of 18 to 25 kg/m2 inclusive.
- Was willing and able to communicate and participate in the entire study.
- Had an understanding, ability and willingness to fully comply with study procedures and restrictions.
- Was willing and able to provide written, personally signed and dated informed consent to participate in the study, in accordance with the ICH GCP Guidelines and applicable regulations, before completing any study-related procedures.
- Agreed to comply with the applicable contraceptive requirements from admission to 90 days after the last dose.
- Had a satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, ECG or laboratory evaluation (haematology, biochemistry, urinalysis) as assessed by the investigator.
Who cannot join
- Current or recurrent disease (eg cardiovascular, respiratory, endocrine, renal, liver, GI, malignancy or other conditions) that could have affected the action, absorption or disposition of the IMP, or could have affected clinical or laboratory assessments.
- Current or relevant previous history of physical or psychiatric illness, any medical disorder that may have required treatment or made the subject unlikely to fully complete the study, or any condition that presented undue risk from the IMP or study procedures.
- Significant illness, as judged by the investigator, within 2 weeks of the first dose of IMP.
- Current use (defined as use within 14 days of first IMP dose) of any medication, including prescription, over-the-counter, herbal or homeopathic preparations (other than 4 g per day of paracetamol).
- Subjects who had received prohibited medication
- Known or suspected intolerance or hypersensitivity to the IMP, closely related compounds or any of the stated ingredients.
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- History of alcohol or other substance abuse within the last year. A positive result for alcohol or drugs of abuse.
- Male subjects who consumed more than 21 units of alcohol per week or 3 units per day (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
- A positive human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) test.
- Use of tobacco in any form (eg smoking or chewing) or other nicotine-containing products in any form (eg gum, patch). Ex-users had to report that they had stopped using tobacco for at least 90 days before receiving the first dose of IMP. A breath carbon monoxide (CO) reading of greater than 10 ppm at screening.
- Donation of blood or blood products (eg plasma or platelets) of greater than 400 mL within 90 days before receiving IMP.
- Use of another IMP within 90 days before receiving the first dose of IMP, or active enrolment in another drug or vaccine clinical study.
- Subjects who had previously been enrolled in this study.
- Clinically significant abnormal biochemistry, haematology or urinalysis result as judged by the investigator.
- Presence or history of allergy requiring treatment. Hayfever was allowed as long as it was inactive.
- Failure to satisfy the investigator of fitness to participate for any other reason.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Within Group, Randomised, Phase I, Repeated Doses, Placebo and Octreotide Controlled Study in Healthy Volunteers to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Incremental Doses of ITF2984
This was a within group, randomised, repeated dose, placebo- and octreotide controlled study in a target population of 45 healthy male subjects. Subjects were required to attend the clinical for screening procedures between 3 and 28 days before dosing commenced. The study was conducted in 4 groups of subjects; Groups 1 to 3 were a double-blinded, randomised design, each consisting of 12 subjects. Group 4 was an open-label design and consisted of 9 subjects. There was a minimum interval of 96 h between dosing of Groups 1, 2 and 3 to allow for interim analyses of PK and safety/tolerability data for dose escalation purposes. Group 4 (the active control group) was still to proceed if the decision was taken to prematurely stop dosing with ITF2984 (somatostatin analogue) following review of the PK and safety data presented at the interim decision meeting; dosing of this group was conducted independently from Groups 1 to 3. On Days 1 to 6, subjects in Groups 1 to 3 were to receive 2 doses of investigational medicinal product (IMP) approximately 12 h apart; subjects in Group 4 were to receive 3 doses of IMP approximately 8 h apart. For all groups, subjects were scheduled to receive their final dose of IMP on the morning of Day 7.
In addition, subjects were to receive exogenous test administrations(stimulation test) on Day -1, Day 1 and Day 7 at the same time on each day (ie for Day -1, 23.5 h before the first dose of IMP, and for Days 1 and 7, 0.5 h after the first dose of IMP on the respective day). Blood samples for PD and PK analyses were taken at specified time points after each dosing.
Subjects remained on site for 10 days (ie 36 h after the final dose of IMP on Day 7) providing that discharge conditions had been met, and returned to the clinic between 5 and 10 days after the last IMP administration for a follow-up visit.
- Conditions
- Healthy Male Volunteers
- Being tested
- ITF2984 (500, 1000, 2000 mcg bid for 7 days), octreotide 50 mcg tid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITF2984 (500, 1000, 2000 mcg bid for 7 days)Drug
Also called somatostatin analogue
octreotide 50 mcg tidDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ITF2984 500 mcg/Placebo sc bid for 7 days | Experimental | TF2984 500 mcg/Placebo sc bid for 7 days Receives: Drug: ITF2984 (500, 1000, 2000 mcg bid for 7 days); Drug: Placebo |
| ITF2984 1000 mcg/Placebo sc bid for 7 days | Experimental | ITF2984 1000 mcg/Placebo sc bid for 7 days Receives: Drug: ITF2984 (500, 1000, 2000 mcg bid for 7 days); Drug: Placebo |
| ITF2984 2000 mcg/Placebo sc bid for 7 days | Experimental | ITF2984 2000 mcg/Placebo sc bid for 7 days Receives: Drug: ITF2984 (500, 1000, 2000 mcg bid for 7 days); Drug: Placebo |
| octreotide 50 mcg tid | Active comparator | octreotide 50 mcg tid Receives: Drug: octreotide 50 mcg tid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of ITF2984 on GH, insulin, glucagon and glucose after exogenous stimulus
Measured: 7 days
To evaluate the safety profile of repeated doses of ITF2984
Numbers of Adverse Events
Measured: 10 days after last dose administration
To evaluate the pharmacodynamic effects of ITF2984 on glucose, insulin, IGF-1, IGF-BP1 and IGF-BP3
Measured: 7 days
to evaluate the effects of ITF2984 on TSH, ACTH, Cortisol, PRL, LH and FSH after exogenous stimulus
Measured: 7 days
Secondary outcomes (1)
To observe the plasma concentration of ITF2984 repeated doses (500, 1000, 2000 mcg bid for 7 days)
Measured: from the first administration to 10 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italfarmaco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871844
- Sponsor's protocol ID
- DSC/09/2984/02
- Other IDs
- 2011-003526-27
- Acronym
- MAD
- Status last verified
- Jun 2013
- First submitted
- 22 May 2013
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Within Group, Randomised, Phase I, Repeated Doses, Placebo and Octreotide Controlled Study in Healthy Volunteers to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Incremental Doses of ITF2984
- ClinicalTrials.gov ID
- NCT01871844
- Acronym / sponsor ID
- MAD / DSC/09/2984/02
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- ItalfarmacoIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 Jun 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.
This was a within group, randomised, repeated dose, placebo- and octreotide controlled study in a target population of 45 healthy male subjects. Subjects were required to attend the clinical for screening procedures between 3 and 28 days before dosing commenced. The study was conducted in 4 groups of subjects; Groups 1 to 3 were a double-blinded, randomised design, each consisting of 12 subjects. Group 4 was an open-label design and consisted of 9 subjects. There was a minimum interval of 96 h between dosing of Groups 1, 2 and 3 to allow for interim analyses of PK and safety/tolerability data for dose escalation purposes. Group 4 (the active control group) was still to proceed if the decision was taken to prematurely stop dosing with ITF2984 (somatostatin analogue) following review of the PK and safety data presented at the interim decision meeting; dosing of this group was conducted independently from Groups 1 to 3. On Days 1 to 6, subjects in Groups 1 to 3 were to receive 2 doses of investigational medicinal product (IMP) approximately 12 h apart; subjects in Group 4 were to receive 3 doses of IMP approximately 8 h apart. For all groups, subjects were scheduled to receive their final dose of IMP on the morning of Day 7.
In addition, subjects were to receive exogenous test administrations(stimulation test) on Day -1, Day 1 and Day 7 at the same time on each day (ie for Day -1, 23.5 h before the first dose of IMP, and for Days 1 and 7, 0.5 h after the first dose of IMP on the respective day). Blood samples for PD and PK analyses were taken at specified time points after each dosing.
Subjects remained on site for 10 days (ie 36 h after the final dose of IMP on Day 7) providing that discharge conditions had been met, and returned to the clinic between 5 and 10 days after the last IMP administration for a follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ITF2984 500 mcg/Placebo sc bid for 7 days | Experimental | Drug: ITF2984 (500, 1000, 2000 mcg bid for 7 days), Drug: PlaceboTF2984 500 mcg/Placebo sc bid for 7 days |
| ITF2984 1000 mcg/Placebo sc bid for 7 days | Experimental | Drug: ITF2984 (500, 1000, 2000 mcg bid for 7 days), Drug: PlaceboITF2984 1000 mcg/Placebo sc bid for 7 days |
| ITF2984 2000 mcg/Placebo sc bid for 7 days | Experimental | Drug: ITF2984 (500, 1000, 2000 mcg bid for 7 days), Drug: PlaceboITF2984 2000 mcg/Placebo sc bid for 7 days |
| octreotide 50 mcg tid | Active comparator | Drug: octreotide 50 mcg tidoctreotide 50 mcg tid |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy Caucasian male volunteers between 18 and 50 years of age, inclusive.
- Body mass index (BMI) of 18 to 25 kg/m2 inclusive.
- Was willing and able to communicate and participate in the entire study.
- Had an understanding, ability and willingness to fully comply with study procedures and restrictions.
- Was willing and able to provide written, personally signed and dated informed consent to participate in the study, in accordance with the ICH GCP Guidelines and applicable regulations, before completing any study-related procedures.
Key exclusion criteria (16 listed)
- Current or recurrent disease (eg cardiovascular, respiratory, endocrine, renal, liver, GI, malignancy or other conditions) that could have affected the action, absorption or disposition of the IMP, or could have affected clinical or laboratory assessments.
- Current or relevant previous history of physical or psychiatric illness, any medical disorder that may have required treatment or made the subject unlikely to fully complete the study, or any condition that presented undue risk from the IMP or study procedures.
- Significant illness, as judged by the investigator, within 2 weeks of the first dose of IMP.
- Current use (defined as use within 14 days of first IMP dose) of any medication, including prescription, over-the-counter, herbal or homeopathic preparations (other than 4 g per day of paracetamol).
- Subjects who had received prohibited medication
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 (500, 1000, 2000 mcg bid for 7 days)Also: somatostatin analogue | Drug | ITF2984 1000 mcg/Placebo sc bid for 7 days, ITF2984 2000 mcg/Placebo sc bid for 7 days, ITF2984 500 mcg/Placebo sc bid for 7 days |
| octreotide 50 mcg tid | Drug | octreotide 50 mcg tid |
| Placebo | Drug | ITF2984 1000 mcg/Placebo sc bid for 7 days, ITF2984 2000 mcg/Placebo sc bid for 7 days, ITF2984 500 mcg/Placebo sc bid for 7 days |
Primary outcome
To evaluate the effects of ITF2984 on GH, insulin, glucagon and glucose after exogenous stimulus
Time frame: 7 days
To evaluate the safety profile of repeated doses of ITF2984
Time frame: 10 days after last dose administration
Numbers of Adverse Events
To evaluate the pharmacodynamic effects of ITF2984 on glucose, insulin, IGF-1, IGF-BP1 and IGF-BP3
Time frame: 7 days
to evaluate the effects of ITF2984 on TSH, ACTH, Cortisol, PRL, LH and FSH after exogenous stimulus
Time frame: 7 days
1 secondary outcome
To observe the plasma concentration of ITF2984 repeated doses (500, 1000, 2000 mcg bid for 7 days)
Time frame: from the first administration to 10 days after last drug administration
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 7 Jun 2013.
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Health Volunteers
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ITF2984 (500, 1000, 2000 mcg bid for 7 days) and octreotide 50 mcg tid in people with Healthy Male Volunteers, run by Italfarmaco at 2 sites in 2 countries.
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 7 inclusion and 16 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 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, United Kingdom. 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 evaluate the effects of ITF2984 on GH, insulin, glucagon and glucose after exogenous stimulus (time frame: 7 days). The study lists 4 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 7 Jun 2013.