A double-blind, randomised, placebo-controlled, 4-way cross-over Phase I study to investigate the pharmacokinetics, pharmacodynamics and safety of escalating single doses of E-52862 in young healthy male and female subjects

• Conditions: Pain; MedDRA version: 12.1Level: LLTClassification code 10033371Term: Pain; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2010-020343-13-GB
• Lead Sponsor: aboratorios del Dr Esteve S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-11
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Healthy male or female subjects aged between 18 and 35 years (inclusive) at
screening.
2. Signed informed consent in the local language prior to any study-mandated procedure.
3. No clinically significant findings on the physical examination at screening and at
admission on Day -2 of Period 1.
4. Body mass index (BMI) between 18 and 25 kg/m2 (inclusive) at screening and at
admission on Day -2 of Period 1, body weight at least 45 kg.
5. Systolic blood pressure 100–130 mmHg, diastolic blood pressure 60–80 mmHg, and
pulse rate 40–90 bpm (all inclusive), measured on the left arm, after 10 minutes in the
supine position at screening and at admission on Day -2 of Period 1.
6. Triplicate 12-lead ECG without clinically relevant abnormalities measured after 10
minutes in the supine position at screening and at admission on Day -2 of Period 1.
7. 24-hour 5-lead Holter ECG without clinically relevant abnormalities measured at
screening.
8. Haematology, biochemistry, and urinalysis test results not deviating from the normal
range to a clinically relevant extent at screening and at admission on Day -2 of Period
1.
9. The Caucasian subjects should be distinguished especially by very light to brown skin
pigmentation and straight to wavy or curly hair, and should be indigenous to Europe,
northern Africa, western Asia, and India. Therefore, the study may as well include
Caucasian subjects from North America, Australia and South Africa.
10. Subjects must agree to use acceptable methods of contraception
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

1. History or clinical evidence of any disease and/or existence of any surgical or medical
condition which might interfere with the absorption, distribution, metabolism or
excretion of the study drug (appendectomy and herniotomy allowed, cholecystectomy
not allowed).
2. History of clinically significant syncope.
3. Family history of sudden death.
4. Family history of premature cardiovascular death.
5. Clinically significant history or family history of congenital long QT syndrome (e.g.
Romano-Ward syndrome, Jervell and Lange-Nielson syndrome) or Brugada's
syndrome.
6. History of clinically significant arrhythmias and ischemic heart disease (especially
ventricular arrhythmias, atrial fibrillation, recent conversion from atrial fibrillation or
coronary spasm).
7. Conditions predisposing the volunteer to electrolyte imbalances (e.g. altered nutritional
states, chronic vomiting, anorexia nervosa, bulimia nervosa).
8.ECG abnormalities in the standard 12-lead ECG (at screening and Day -2 of Period 1) and 24-hour 5-lead Holter ECG (at screening) which in the opinion of the Investigator will interfere with the ECG analysis.
9. Any clinically important abnormalities in rhythm, conduction or morphology of resting
ECG that may interfere with the interpretation of QTc interval changes. This includes
subjects with any of the following (at screening and Day -2 of Period 1):
• Sinus node dysfunction.
• Clinically significant PR (PQ) interval prolongation.
• Intermittent second or third degree AV block.
• Incomplete or complete bundle branch block.
• Abnormal T-wave morphology.
• Prolonged QTcB >450 msec or shortened QTcB <350 msec or family history of
long QT syndrome.
Subject with borderline deviations from these criteria may be included if the deviations do not pose a safety risk, and if agreed between the appointed Cardiologist and the Principal Investigator.
10. Signs and/or symptoms of a clinically relevant acute illness in the 4-week period prior to screening.
11. Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture).
12. Known hypersensitivity to any medicines administered in the trial.
13. Treatment with any prescribed medication during the two weeks prior to first baseline day.
14. Treatment with any over-the-counter (OTC) medications during the two weeks prior to first baseline day.
15. Treatment with vitamins and/or minerals within 48 hours prior to the first baseline day.
16. Treatment with another investigational drug within three months prior to dosing or having participated in more than three investigational drug studies within 1 year prior to dosing.
17. Confirmed positive results from urine drug screen (amphetamines, benzodia
cocaine, cannabinoids, opiates, barbiturates and methadone) or from the alcohol
breath test at screening and on Day -2 of Period 1.
18. History or clinical evidence of alcoholism or drug abuse. Alcohol abuse is defined as regular weekly intake of more than 14 units if female and 21 units if male; drug abuse is defined as compulsive, repetitive and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms.
19. Excessive caffeine consumption, defined as = 800 mg per day at screening (800 mg = 7 cups of coffee or 16 cups of tea).
20. Chronic use o

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified