NCT01871844

ITF2984 Repeated Doses Study in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Italfarmaco · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Male Volunteers

Interventions

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

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-09-01
• Completion: 2013-05-01
• First posted: 2013-06-07
• Last updated: 2013-06-07

Locations

2 sites across 2 countries: Italy, United Kingdom