Trial Outcomes & Findings for Intranasal Administration of Neuropeptide Y in Healthy Male Volunteers (NCT NCT00748956)

Results Overview

Levels of Neuropeptide Y in the cerebrospinal fluid

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

on study day 2

Results posted on

2017-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	High Dose NPY High Dose, Receive 100 nmol dose of NPY High dose NPY: 100nmol administered intranasally	Placebo Placebo comparator Placebo: placebo comparator (0nmol)) administered intranasally
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intranasal Administration of Neuropeptide Y in Healthy Male Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose NPY Low dose, Receive 50 nmol dose of NPY Low dose NPY: 50nmol, administered intranasally	High Dose NPY n=5 Participants High Dose, Receive 100 nmol dose of NPY High dose NPY: 100nmol administered intranasally	Placebo n=5 Participants Placebo comparator Placebo: placebo comparator (0nmol)) administered intranasally	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	—	5 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Age, Categorical >=65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	—	5 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants

PRIMARY outcome

Timeframe: on study day 2

Levels of Neuropeptide Y in the cerebrospinal fluid

Outcome measures

Outcome measures
Measure	Low Dose NPY Low dose, Receive 50 nmol dose of NPY Low dose NPY: 50nmol, administered intranasally	High Dose NPY n=5 Participants High Dose, Receive 100 nmol dose of NPY High dose NPY: 100nmol administered intranasally	Placebo n=5 Participants Placebo comparator Placebo: placebo comparator (0nmol)) administered intranasally
Levels of NPY in CSF	—	329.4 pg/mL Standard Deviation 119.9	351.0 pg/mL Standard Deviation 41.6

SECONDARY outcome

Timeframe: on study day 2

Number of participants with serious adverse events

Outcome measures

Outcome measures
Measure	Low Dose NPY Low dose, Receive 50 nmol dose of NPY Low dose NPY: 50nmol, administered intranasally	High Dose NPY n=5 Participants High Dose, Receive 100 nmol dose of NPY High dose NPY: 100nmol administered intranasally	Placebo n=5 Participants Placebo comparator Placebo: placebo comparator (0nmol)) administered intranasally
Systematic Assessment of Treatment-Emergent Effects (SAFTEE)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: on study day 2

Population: data not collected

measure in 2 hours post intranasal administration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: on study day 2

Population: data not collected

measure in the morning

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: on study day 2

Population: data not collected

measure in 2 hours post intranasal administration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: on study day 2

Population: data not collected

measure in 2 hours post intranasal administration and on the next morning

Outcome measures

Outcome data not reported

Adverse Events

Low Dose NPY

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Dose NPY

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Low Dose NPY Low dose, Receive 50 nmol dose of NPY Low dose NPY: 50nmol, administered intranasally	High Dose NPY n=5 participants at risk High Dose, Receive 100 nmol dose of NPY High dose NPY: 100nmol administered intranasally	Placebo n=5 participants at risk Placebo comparator Placebo: placebo comparator (0nmol)) administered intranasally
Nervous system disorders Headache and Nausea	— 0/0	0.00% 0/5	20.0% 1/5
Nervous system disorders Headache	— 0/0	20.0% 1/5	0.00% 0/5

Other adverse events

Adverse event data not reported

Additional Information

Dr. Adriana Feder

Icahn School of Medicine at Mount Sinai

Phone: 212-659-9145

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place