Transient misalignment of the sleep-wake cycle as a result of working night shifts (insomnia in night shift workers)
Conditions
Interventions
Product Code: APL-510
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: melatonin
CAS Number: 73-31-4
Current Sponsor code: APL-510
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
Alliance Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18-65 working permanent night shifts with at least 3 consecutive night shifts in their shift pattern. A female subject may be included if: She is of non-child-bearing potential (e.g. post-menopausal for one year, had bilateral tubal ligation, had a hysterectomy or is physiologically incapable of becoming pregnant), or She is of childbearing potential practicing an acceptable method of birth control defined as the use of oral or depot hormonal contraception, an intrauterine contraceptive device or a combination of both spermicidal and barrier methods of contraception. A partner having had a vasectomy is not an acceptable reason for inclusion, or Total abstinence from sexual intercourse is maintained. 2. Written informed consent. 3. No planned absences from work, other than rest days, for the duration the subject will be in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have a clinically significant unstable medical abnormality, chronic disease or history or presence of significant neurological, hepatic, renal, endocrine, cardiovascular, GI, pulmonary, psychiatric, metabolic disease or malignancy or other clinically relevant abnormality which in the opinion of the investigator would preclude successful participation in the study. 2. Have a recent history of ( 2X the upper limit of normal or creatinine clearance of <35ml/min. 8. Subjects with a known severe allergic or auto-immune disease (e.g. multiple sclerosis, rheumatoid arthritis, severe asthma and systemic lupus erythematosus). 9. Subjects who have received an experimental drug within the previous 3 months. 10. Subjects who use melatonin. 11. Subjects, who, by virtue of the need to care for close family members, may be subjected to intermittent disturbance during their daytime rest periods. 12. Subjects who, in the opinion of the investigator, are not capable of completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if the administration of 1.5mg APL510 can increase the length of daytime sleep following a night shift. ;Secondary Objective: 1. To determine if the administration of 1.5mg APL510 can increase the maintenance of daytime sleep and reduce sleep latency and the number of episodes of disturbed sleep following a night shift. 2. To determine if the use of 1.5mg APL510 has any ‘hang-over’ effect during the night shift work period. 3. To compare the adverse event profiles of APL510 and placebo.;Primary end point(s): The primary measure of efficacy will be a change in the subjects’ total sleep time. | — |
Countries
United Kingdom
Outcome results
None listed