Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia

NCT01114126 | Completed Phase 1 DMC

• 1 other identifier: Neu-P11
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluate the safety and tolerability of Neu-P11, following the administration of multiple ascending oral doses (2, 5, 20, 50 mg or matching placebo) given nightly over 2 periods of 5 days to male and female subjects with primary insomnia. In addition, the study is aimed to determine the pharmacokinetic profile of Neu-P11 after 1 and 5 days of administration and to evaluate the hypnotic effects of Neu-P11 as well as the effects on mood and memory. The study hypothesis is that Neu-P11 is safe, tolerated and have significant sleep promoting effects.

Conditions

Insomnia

Keywords

Neu-P11; Insomnia; PSG; safety

Outcome Measures

Primary Outcomes (1)

• Number and description of participants with adverse events

  adverse events will be recorded and reported throughout the study

  5 days

Secondary Outcomes (3)

• Neu-P11 concentration, exposure and clearance

  5 days

• Objective and subjective assessment sleep quality

  5 days

• Subjective evaluation of mood and emotions

  5 days

Study Arms (5)

Neu-P11 2mg

EXPERIMENTAL

Drug: Neu-P11

Neu-P11 5 mg

EXPERIMENTAL

Drug: Neu-P11

Neu-p11 20 mg

EXPERIMENTAL

Drug: Neu-P11

Neu-P11 50 mg

EXPERIMENTAL

Drug: Neu-P11

Placebo

PLACEBO COMPARATOR

Drug: Neu-P11 placebo

Interventions

Neu-P11 DRUG

comparison of different dosages of drug

Neu-P11 2mg; Neu-P11 5 mg; Neu-P11 50 mg; Neu-p11 20 mg

Neu-P11 placebo DRUG

comparison of different dosages

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary insomnia male or female subjects according to DSM-IV criteria (307.42) ,
• Men or women 18 to 65 years inclusive,
• Women of childbearing potential must have a negative pregnancy test at the screening visit, on Day 1 of each treatment period, and use a reliable method of contraception during the entire study duration and for at least 3 months after study drug intake. Reliable methods of contraception are:
• Double barrier type devices (e.g., male or female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
• Intra-uterine devices in combination with a spermicide. Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile.
• Subjects must be in good health as determined by their medical history, physical examination, ECG, vital signs, standard EEG, serum biochemistry, haematology and urinalysis. A subject with clinical abnormality may be included only if the investigator or his designee considers that the abnormality will not introduce additional risk factor for the subject's health, or interfere with the study objectives,
• Subjects who have not been using BZD and non-BZD hypnotics or melatoninergic drugs for the past 2 weeks or more prior to Screening,
• Subjects who have not been using psychotropic treatments for the past 3 months or more prior to screening,
• Subjects who have not been using any other non-psychotropic treatments for the past 2 weeks or more prior to Screening with the exception of occasional paracetamol intake (1 g per day),
• Subjects having read and signed the informed consent form,
• Subjects having a body mass index between 18 and 30 (extremes included),
• Subjects having no documented hypersensitivity to exogenous melatonin or agonists,
• Subjects who agree to completely refrain from alcohol, caffeine and tobacco during the institutionalisation periods,
• Subjects able to take part in the whole study,
• Subjects affiliated with, or beneficiary of, a social security system

You may not qualify if:

• According to DSM IV, subjects belonging to the following groups are excluded: 780.59 (breathing related sleep disorder); 307.45 (circadian rhythm sleep disorder); 307.47 (dyssomnia not otherwise specified); 780.xx (sleep disorder due to general medical condition) ,
• Subjects suffering from insomnia secondary to other causes according to SHQ,
• Subjects with known chronic infections or asthma, allergies or history of severe allergy,
• Subjects with hypertension defined as systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg according to two repeated measures in lying position within 10 min interval,
• Subjects with hypotension defined as systolic blood pressure \<90 mmHg and/or diastolic blood pressure \< 45 mmHg according to two repeated measures in lying position within 10 min interval,
• Subjects with foreseeable need of a treatment, whatever it is (including dental care), during the study period,
• Subjects with positive drug screening for amphetamines, benzodiazepines, barbiturates, cannabis, cocaine morphine/opiates, methadone, tricyclics, methamphetamines (ecstasy) and codeine, or suspected to be drug or alcohol addicted,
• Subjects with positive serology to human immunodeficiency virus antibodies (HIV Ab),
• Subjects positive for Hepatitis B virus surface antigen (HBs Ag) or hepatitis C virus antibodies (HCV Ab),
• Subjects with previous or on-going chronic or recurrent disease especially convulsive disorders or central nervous system or psychiatric disease,
• Subjects with history of pathology likely to recur during or immediately after the study,
• Subjects with significant cardio-vascular, pulmonary, renal, hepatic, gastro-intestinal, neurological, psychiatric, endocrine, cancer or blood disease,
• Subjects having taken any unstable treatment with central effects within 90 days prior to experiment,
• Subjects with an alcohol consumption more than 40 g of alcohol per day,
• Subjects drinking more than 6 cups of coffee (or equivalent in xanthine-containing beverages) per day,

Sponsors & Collaborators

• Neurim Pharmaceuticals Ltd.: lead

Study Sites (1)

Centre hospitallier de Rouffach

Rouffach, 68250, France

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

N-(2-(5-methoxy-indol-3-yl)-ethyl)-4-oxo-4H-pyran-2-carboxamide

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Deborah Metzger, MD

  Forenap Pharma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 30, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 7, 2011

Record last verified: 2011-04

Locations

FR (1)