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Semax

ACTH(4-10) analogue, Heptapeptide SEMAX

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Studies 172
Trials 37
Completed PHASE1 INTERVENTIONAL NCT01871844

ITF2984 Repeated Doses Study in Healthy Volunteers

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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. 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.

Interventions

Name: ITF2984 (500, 1000, 2000 mcg bid for 7 days)
Type: DRUG
Description:
Name: octreotide 50 mcg tid
Type: DRUG
Description:
Name: Placebo
Type: DRUG
Description:

Primary Outcomes

Measure: To evaluate the effects of ITF2984 on GH, insulin, glucagon and glucose after exogenous stimulus
TimeFrame: 7 days
Description:
Measure: To evaluate the safety profile of repeated doses of ITF2984
TimeFrame: 10 days after last dose administration
Description: Numbers of Adverse Events
Measure: To evaluate the pharmacodynamic effects of ITF2984 on glucose, insulin, IGF-1, IGF-BP1 and IGF-BP3
TimeFrame: 7 days
Description:
Measure: to evaluate the effects of ITF2984 on TSH, ACTH, Cortisol, PRL, LH and FSH after exogenous stimulus
TimeFrame: 7 days
Description:

Trial Information

NCT ID

NCT01871844

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Italfarmaco

Last Updated

December 15, 2025