Clinical Trial Results:
Gastrointestinal Behavior of Posaconazole in Healthy Volunteers
Summary
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EudraCT number |
2015-002703-28 |
Trial protocol |
BE |
Global end of trial date |
28 Feb 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Feb 2020
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First version publication date |
12 Feb 2020
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Other versions |
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Summary report(s) |
Posaconazole - Tablet - Article |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
DDD15POSA
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
KU Leuven
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Sponsor organisation address |
Herestraat 49, Leuven, Belgium, 3000
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Public contact |
Drug Delivery & Disposition, KU Leuven, +32 16330302, bart.hens@pharm.kuleuven.be
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Scientific contact |
Drug Delivery & Disposition, KU Leuven, +32 16330302, bart.hens@pharm.kuleuven.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Feb 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Feb 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Feb 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Study of the gastrointestinal (GI) behavior of posaconazol in healthy volunteers by administerting the Noxafil tablet (posaconazole, 100 mg) in fasted and fed state conditions to five healthy subjects. The obtained data will learn us more about the luminal behavior of posaconazole and the impact of different GI in the GI tract after being administered as a solid dispersion tablet (supersaturation/ precipitation/ dissolution/ ...).
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Protection of trial subjects |
Not applicable.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Aug 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 5
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Worldwide total number of subjects |
5
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EEA total number of subjects |
5
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
5
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
Exclusion criteria for this clinical study were gastrointestinal disorders, infection with hepatitis B, hepatitis C, or HIV, use of medication, pregnancy, and frequent X-ray exposure. These criteria were checked for every volunteer during a medical examination. | |||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
Not relevant.
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Fasted state conditions | |||||||||
Arm description |
In the first test condition, one tablet of 100 mg posaconazole was taken orally with 240 mL of water. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Posaconazole
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
In the first test condition, one tablet of 100 mg posaconazole was taken orally with 240 mL of water. In the second test condition, volunteers were asked to drink 400 mL of Ensure Plus® nutrient shake (Abbott Laboratories B.V., Zwolle, The Netherlands), 20 min prior to oral intake of the tablet with 240 mL of water.
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Arm title
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Fed state conditions | |||||||||
Arm description |
In the second test condition, volunteers were asked to drink 400 mL of Ensure Plus® nutrient shake (Abbott Laboratories B.V., Zwolle, The Netherlands), 20 min prior to oral intake of the tablet with 240 mL of water. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Posaconazole
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
In the second test condition, volunteers were asked to drink 400 mL of Ensure Plus® nutrient shake (Abbott Laboratories B.V., Zwolle, The
Netherlands), 20 min prior to oral intake of the tablet (100 mg) with 240 mL of water.
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Baseline characteristics reporting groups
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Reporting group title |
Fasted state conditions
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Reporting group description |
In the first test condition, one tablet of 100 mg posaconazole was taken orally with 240 mL of water. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fed state conditions
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Reporting group description |
In the second test condition, volunteers were asked to drink 400 mL of Ensure Plus® nutrient shake (Abbott Laboratories B.V., Zwolle, The Netherlands), 20 min prior to oral intake of the tablet with 240 mL of water. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Fasted state conditions
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Reporting group description |
In the first test condition, one tablet of 100 mg posaconazole was taken orally with 240 mL of water. | ||
Reporting group title |
Fed state conditions
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Reporting group description |
In the second test condition, volunteers were asked to drink 400 mL of Ensure Plus® nutrient shake (Abbott Laboratories B.V., Zwolle, The Netherlands), 20 min prior to oral intake of the tablet with 240 mL of water. |
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End point title |
Gastrointestinal and plasma AUC, Cmax and Tmax | ||||||||||||
End point description |
In order to determine dissolved concentrations of posaconazole in gastrointestinal fluids, aspirates were immediately centrifuged
(20,817 g, 5 min) and the supernatant was 20-fold diluted in mobile phase (methanol: 25 mM acetic acid buffer pH 3.5 [85:15
vol/vol]). To determine the total posaconazole content (i.e., solute + solid), aspirates were directly diluted 20-fold in mobile phase. In
both cases, precipitated proteins were separated with an additional centrifugation step (20,817 g, 5 min, 37°C). Samples were analyzed by HPLC-FLUO.
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End point type |
Primary
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End point timeframe |
GI concentrations up to 4 h and plasma samples up to 24 h
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Statistical analysis title |
Data Presentation and Statistical Analysis | ||||||||||||
Comparison groups |
Fed state conditions v Fasted state conditions
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Number of subjects included in analysis |
9
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Analysis specification |
Post-hoc
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 1-sided | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
No adverse events were noted during or after this study.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
Excel file | ||
Dictionary version |
office 365
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There were no adverse events noted. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Not applicable. | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/27178739 |