Clinical Trial Results:
STUDY TO EVALUATE THE PROPORTIONALITY OF 3 ORAL DOSES OF PIRLINDOLE IN HEALTHY VOLUNTEERS.
Summary
|
|
EudraCT number |
2012-003090-26 |
Trial protocol |
ES |
Global end of trial date |
02 May 2013
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
08 Aug 2020
|
First version publication date |
08 Aug 2020
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
110401
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Tecnimede, Sociedade Técnico-Medicinal, S.A.
|
||
Sponsor organisation address |
Zona Industrial da Abrunheira, R. da Tapada Grande, nº 2, Sintra, Portugal, 2710-089
|
||
Public contact |
SPONSOR'S REPRESENTATIVE, Tecnimede, Sociedade Técnico-Medicinal, S.A., +351 210414187, dmed.ct@tecnimede.pt
|
||
Scientific contact |
SPONSOR'S REPRESENTATIVE, Tecnimede, Sociedade Técnico-Medicinal, S.A., +351 210414187, dmed.ct@tecnimede.pt
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
02 May 2013
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
02 May 2013
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
02 May 2013
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
Main objective is to assess the proportionality of 3 pirlindole doses (50, 100 and 150 mg) administered orally in healthy volunteers.
|
||
Protection of trial subjects |
The study was conducted following the international recommendations for clinical research gathered in the declaration of Helsinki and its updating (revised in Tokyo 1975, Venice 1983, Hong Kong 1989, Sommerset West 1996, Edinburgh 2000, Washington 2002 and Seoul, South Korea 2008) and following the ICH Harmonized tripartite Guidelines for Good Clinical Practice (CPMP/ICH/135/95), guidelines of the Spanish Ministry of Health (Spanish Real Decret 223/2004) as well as the Directive 2001/20/EC (Note for Guidance “Good Clinical Practice for Studies on Medicinal Products in the European Community”).
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Apr 2013
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Spain: 18
|
||
Worldwide total number of subjects |
18
|
||
EEA total number of subjects |
18
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
18
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||||||||
Recruitment
|
|||||||||||||
Recruitment details |
Study participants were selected from the panel of volunteers at the Centre d’ Investigació de Medicaments CIM-Sant Pau. The beginning of the study (“first subject in") was on 29 April 2013. | ||||||||||||
Pre-assignment
|
|||||||||||||
Screening details |
The screening was performed during the four weeks and the final evaluation was carried out the day after the administration of the medication. During the screening period (four weeks before the randomization) all participants gave their informed consent and underwent a screening check-up to verify that they met the inclusion/exclusion criteria. | ||||||||||||
Period 1
|
|||||||||||||
Period 1 title |
Overall period
|
||||||||||||
Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||
Blinding used |
Not blinded | ||||||||||||
Arms
|
|||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||
Arm title
|
Pirlindole 50 mg | ||||||||||||
Arm description |
All participants who received Pirlindole (50mg) and who were not excluded from the pharmacokinetic population. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Pirlindole
|
||||||||||||
Investigational medicinal product code |
|||||||||||||
Other name |
|||||||||||||
Pharmaceutical forms |
Tablet
|
||||||||||||
Routes of administration |
Oral use
|
||||||||||||
Dosage and administration details |
One single oral dose of Pirlindole 50 mg (one tablet of 50mg) was administered under fasting conditions. The medication was administrated with 240 ml of water.
|
||||||||||||
Arm title
|
Pirlindole 100 mg | ||||||||||||
Arm description |
All participants who received Pirlindole (100 mg) and who were not excluded from the pharmacokinetic population. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Pirlindole
|
||||||||||||
Investigational medicinal product code |
|||||||||||||
Other name |
|||||||||||||
Pharmaceutical forms |
Tablet
|
||||||||||||
Routes of administration |
Oral use
|
||||||||||||
Dosage and administration details |
One single oral dose of Pirlindole 100 mg (two tablets of 50mg) was administered under fasting conditions. The medication was administrated with 240 ml of water.
|
||||||||||||
Arm title
|
Pirlindole 150 mg | ||||||||||||
Arm description |
All participants who received Pirlindole (150 mg) and who were not excluded from the pharmacokinetic population. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Pirlindole
|
||||||||||||
Investigational medicinal product code |
|||||||||||||
Other name |
|||||||||||||
Pharmaceutical forms |
Tablet
|
||||||||||||
Routes of administration |
Oral use
|
||||||||||||
Dosage and administration details |
One single oral dose of Pirlindole 150 mg (three tablets of 50mg) was administered under fasting conditions. The medication was administrated with 240 ml of water.
|
||||||||||||
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall period
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Pirlindole 50 mg
|
||
Reporting group description |
All participants who received Pirlindole (50mg) and who were not excluded from the pharmacokinetic population. | ||
Reporting group title |
Pirlindole 100 mg
|
||
Reporting group description |
All participants who received Pirlindole (100 mg) and who were not excluded from the pharmacokinetic population. | ||
Reporting group title |
Pirlindole 150 mg
|
||
Reporting group description |
All participants who received Pirlindole (150 mg) and who were not excluded from the pharmacokinetic population. |
|
|||||||||||||||||
End point title |
Area under the plasma concentration curve (AUC) from time 0 to last observed concentration of Pirlindole | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Linear regression analysis | ||||||||||||||||
Comparison groups |
Pirlindole 50 mg v Pirlindole 100 mg v Pirlindole 150 mg
|
||||||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other | ||||||||||||||||
Method |
Regression, Linear | ||||||||||||||||
Parameter type |
Coefficient of the regression line | ||||||||||||||||
Point estimate |
1.715
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
0.976 | ||||||||||||||||
upper limit |
2.453 |
|
|||||||||||||||||
End point title |
Maximum concentration (Cmax) in plasma of Pirlindole | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Linear regression analysis | ||||||||||||||||
Comparison groups |
Pirlindole 50 mg v Pirlindole 100 mg v Pirlindole 150 mg
|
||||||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other | ||||||||||||||||
Method |
Regression, Linear | ||||||||||||||||
Parameter type |
Coefficient of the regression line | ||||||||||||||||
Point estimate |
1.339
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
0.77 | ||||||||||||||||
upper limit |
1.908 |
|
|||||||||||||||||
End point title |
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) in plasma of Pirlindole | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Linear regression analysis | ||||||||||||||||
Comparison groups |
Pirlindole 50 mg v Pirlindole 100 mg v Pirlindole 150 mg
|
||||||||||||||||
Number of subjects included in analysis |
18
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other | ||||||||||||||||
Method |
Regression, Linear | ||||||||||||||||
Parameter type |
Coefficient of the regression line | ||||||||||||||||
Point estimate |
1.697
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
0.95 | ||||||||||||||||
upper limit |
2.443 |
|
|||||||||||||||||
End point title |
Elimination rate constant (Kel) of Pirlindole | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Elimination half-life (T ½) of Pirlindole | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Apparent volume of distribution estimated from extravascular route (Vd/F) of Pirlindole | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Total body clearance estimated from extravascular route (Cl/F) of Pirlindole | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Time to reach maximum (peak) plasma concentration (Tmax) of Pirlindole | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV).
|
||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||
Dictionary version |
16.0
|
||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||
Reporting group title |
Pirlindole 50 mg
|
||||||||||||||||||||||||||||
Reporting group description |
All participants who received Pirlindole (50mg) and who were not excluded from the pharmacokinetic population. | ||||||||||||||||||||||||||||
Reporting group title |
Pirlindole 100 mg
|
||||||||||||||||||||||||||||
Reporting group description |
All participants who received Pirlindole (100 mg) and who were not excluded from the pharmacokinetic population. | ||||||||||||||||||||||||||||
Reporting group title |
Pirlindole 150 mg
|
||||||||||||||||||||||||||||
Reporting group description |
All participants who received Pirlindole (150 mg) and who were not excluded from the pharmacokinetic population. | ||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |