Healthy Male Volunteers Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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