A clinical study to evaluate the safety and blood concentration of melatonin nasal suspension in healthy male research participants.

A randomized, double-blind, monocentric, phase I clinical trial to assess the tolerability, safety, and pharmacokinetics of melatonin nasal suspension, after a single dose in healthy male participants.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-3t7fcy

Enrollment

Unknown

Registered

2017-10-31

Start date

2017-12-21

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disturbances of onset and maintenance of sleep (insomnia).

Interventions

Experimental group: 56 healthy men who will receive single dose of melatonin suspension spray 2mg / mL at doses of 0.1, 0.2, 0.4 and 0.8mg and fasted state. Control group: 8 healthy men receiving a si

Drug

M01.774.500

Eligibility

Sex/Gender

Male

Age

18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Healthy research participants; male gender; age equal to 18 and less than or equal to 35 years; body weight greater than or equal to 50 kg and BMI less than or equal to 30 kg / m2.

Exclusion criteria

Exclusion criteria: Research participants with complementary examinations outside normal values; history of excessive alcohol consumption; history of psychotropic drug use; be non-tolerant to the nasal spray test; history of upper or lower respiratory tract infection (1 month prior to study participation).

Design outcomes

Primary

Measure	Time frame
Safety and tolerability variables will be considered: in specific periods the parameters of blood pressure (systolic and diastolic), heart rate, respiratory rate and oxygen saturation will be measured; ECG of 12 variations; Holter electrocardiogram; reporting of Adverse Events (AEs) obtained through general or spontaneously stated questions; all the results of the laboratory tests of the study, results of the videonasofibroscopy examination and clinical evaluation.	—

Measure

Time frame

Safety and tolerability variables will be considered: in specific periods the parameters of blood pressure (systolic and diastolic), heart rate, respiratory rate and oxygen saturation will be measured; ECG of 12 variations; Holter electrocardiogram; reporting of Adverse Events (AEs) obtained through general or spontaneously stated questions; all the results of the laboratory tests of the study, results of the videonasofibroscopy examination and clinical evaluation.

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Secondary

Measure	Time frame
Evaluation of pharmacokinetics by percentage of AUC0-inf which is due to the extrapolation from the last to the infinity (% AUCExtrap); area under the concentration curve versus time, from time 0 (zero) to the time of the last observed concentration (AUC 0-t); area under the drug concentration curve versus 0 (zero) time extrapolated to infinity (AUC0-inf); maximum concentration (Cmax); observed maximum concentration divided by dose (Cmax_D); time where the maximum observed concentration (Tmax) occurs; first order elimination constant (Kel); half-way (T1 / 2); mean residence time (TMR0-t).	—

Measure

Time frame

Evaluation of pharmacokinetics by percentage of AUC0-inf which is due to the extrapolation from the last to the infinity (% AUCExtrap); area under the concentration curve versus time, from time 0 (zero) to the time of the last observed concentration (AUC 0-t); area under the drug concentration curve versus 0 (zero) time extrapolated to infinity (AUC0-inf); maximum concentration (Cmax); observed maximum concentration divided by dose (Cmax_D); time where the maximum observed concentration (Tmax) occurs; first order elimination constant (Kel); half-way (T1 / 2); mean residence time (TMR0-t).

—

Countries

Brazil

Contacts

Public ContactKarini Bellorio

Instituto de Ciências Farmacêuticas

karini.bellorio@icf.com.br+55-062-32401900

Outcome results

None listed

Source: REBEC (via WHO ICTRP)