Clinical Trials Register

Summary
EudraCT Number:	2020-005895-37
Sponsor's Protocol Code Number:	ASP-MEL-CT001
National Competent Authority:	Croatia - MIZ
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-09-02
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Croatia - MIZ

A.2

EudraCT number

2020-005895-37

A.3

Full title of the trial

An open label one-treatment, one-period, one-sequence, single oral dose bioavailability study for Melatonin in healthy, adult, human subjects under fasting conditions.

Otvoreno kliničko ispitivanje za procjenu bioraspoloživosti melatonina, provedeno u jednom razdoblju i slijedu, nakon jednokratne primjene oralne doze kod zdravih, odraslih osoba, uzete natašte

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A bioavailability study of Melatonin oral solution in healthy adults

Ispitivanje bioraspoloživosti oralne otopine melatonina u zdravih, odraslih ispitanika

A.4.1

Sponsor's protocol code number

ASP-MEL-CT001

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Aspire Pharma Limited
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Aspire Pharma Limited
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Aspire Pharma Limited
B.5.2	Functional name of contact point	Clinical Trials Inbox
B.5.3	Address:
B.5.3.1	Street Address	Unit 4 Rotherbrook Court
B.5.3.2	Town/ city	Petersfield
B.5.3.3	Post code	GU32 3QG
B.5.3.4	Country	United Kingdom
B.5.6	E-mail	clinicaltrials@aspirepharma.co.uk

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Melatonin 1 mg/ml oral solution
D.3.2	Product code	N/A
D.3.4	Pharmaceutical form	Oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	melatonin
D.3.9.1	CAS number	73-31-4
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	MELATONIN
D.3.9.4	EV Substance Code	SUB14496MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

E.1.1.1

Medical condition in easily understood language

Jet lag

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10023190
E.1.2	Term	Jet lag
E.1.2	System Organ Class	100000004852

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Characterization of the bioavailability and pharmacokinetic profile of the Sponsor's test product Melatonin 1 mg/ml oral solution

E.2.2

Secondary objectives of the trial

Monitoring of the safety of the subjects

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Negative test results of SARS-CoV-2 RT-PCR test.
2. Healthy human volunteers between 18 and 45 years of age (both inclusive) living in and around the city of Zagreb.
3. Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg/height in meter.
4. Not having significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, and 12 Lead ECG.
5. Able to understand and comply with the study procedures, in the opinion of the Principal investigator.
6. Volunteer who is currently a non-smoker
7. Able to give voluntary written consent for participation in the trial.
8. In case of female subjects:
• Surgically sterilized at least 6 months prior to study participation
Or
• If of child bearing potential: is willing to use a suitable and effective double barrier contraceptive method.
And
• Serum Pregnancy test must be negative

E.4

Principal exclusion criteria

1. Positive test results of SARS-CoV-2 RT-PCR test.
2. Known hypersensitivity or idiosyncratic reaction to Melatonin or to any of its excipients or any related drug or any substance.
3. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
4. Ingestion or use of any medication (prescribed and over the counter (OTC) medication including herbal remedies) at any time in 14 days prior to dosing. In any such case subject selection will be at the discretion of the Principal Investigator.
5. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
6. Consumption of Grapefruits or its products within a period of 24 hours prior to receiving the study drug of period-I.
7. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and 07 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc.) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine.
8. Smokers, or who have smoked within last six months prior to start of the study.
9. The presence of clinically significant abnormal laboratory values during screening.
10. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
11. History or presence of psychiatric disorders.
12. Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within 90 days prior to receiving the dose in this study. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
Note: In case the blood loss was less than or equal to 200 mL; subject may be dosed 60 days after blood donation or after the last sample of previous study
13. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies. A positive test result for HIV antibody (I and II).
14. An unusual diet, for whatever reason (e.g. low-sodium), for four week prior to receiving the study drug. In any such case subject selection will be at the discretion of the Principal Investigator.
15. Nursing mothers (females).

E.5 End points

E.5.1

Primary end point(s)

Cmax, AUC0-t, AUC0-∞, Tmax, λz, t1/2, and AUC_%Extrap_obs.

E.5.1.1

Timepoint(s) of evaluation of this end point

Time schedule
01h before dosing
30 min before dosing
Within 05 minutes prior to dosing
10 min after the dosing
15 min after the dosing
20 min after the dosing
30 min after the dosing
40 min after the dosing
01h after the dosing
02h after the dosing
03h after the dosing
04h after the dosing
06h after the dosing

E.5.2

Secondary end point(s)

Adverse events which will be evaluated for duration, severity, seriousness and unexpectedness, action taken, date and time of resolution and association with the study treatment.

E.5.2.1

Timepoint(s) of evaluation of this end point

Throughout trial.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception