- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02048345
Gastrointestinal Behavior of Posaconazol in Healthy Volunteers
The aim of this study is to understand the behavior of posaconazol gives as a suspension and solution in the gastrointestinal tract in human volunteers. The investigators know that supersaturation for this compound can be achieved by the influence of the gastrointestinal tract: The acid environment of the stomach creates a optimized environment for the basic compound to reach a high solubility, while the neutral environment of the small intestine creates a low solubility environment for the compound. The transit from stomach to small intestine gives the opportunity for the drug to create a supersaturated solution. Giving the drug as a solution to the healthy volunteer makes sure that precipitation is not occurring in the stomach and that precipitation has to happen in the small intestine. After all, supersaturation is a state that is not thermodynamic stable and always will want to precipitate. Giving the drug as a suspension to the healthy volunteers, can make it possible that still some particles of the drug are not in dissolution and that those particles will flow to the small intestine where other particles easily can bind to. This will make that almost the whole supersaturated solution is immediately precipitated.
The investigators want to give the suspension by the authorized drug called Noxafil. On the other hand an aqueous solution will be made by adjusting the pH to 1.2 (which is conform with the pH of the stomach) and given to the volunteers by the stomach catheter. This 2 formulations will be tested in a fasted state and a fed state (by giving 2 Ensure plus shakes to the volunteers before the experiment starts). After intake of the formulation, gastric and duodenal fluids will be aspirated by the catheters and analyzed at their laboratory. So the four conditions the investigators want to study are:
- 10 mL Suspension of posaconazol (Noxafil 40mg/mL) together with a glass of 240 mL water in a fasted state
- 250 mL solution of posaconazol, by dissolving 2.6 mL autohorized suspension (Noxafil) in 247 mL water, adjusted to pH 1.2 by hydrochloric acid given to the volunteer in a fasted state.
- 10 mL Suspension of posaconazol (Noxafil 40mg/mL) together with a glass of 240 mL water in a fed state (by giving 20 minute before intake of the formulation, 2 ensure plus shakes)
- 250 mL solution of posaconazol, by dissolving 2.6 mL autohorized suspension (Noxafil) in 247 mL water, adjusted to pH 1.2 by hydrochloric acid given to the volunteer in a fed state (by giving 20 minute before intake of the formulation, 2 ensure plus shakes).
By getting more knowledge about the behavior of posaconazol (interplay supersaturation / precipitation) more insights can be achieved for the development of supersaturating drug delivery systems.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bart Hens, Pharmacist
- Phone Number: +3216330302
- Email: bart.hens@pharm.kuleuven.be
Study Locations
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-
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Leuven, Belgium, 3000
- Recruiting
- UZ Leuven Gasthuisberg
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Contact:
- Bart Hens, Pharmacist
- Phone Number: +3216330302
- Email: bart.hens@pharm.kuleuven.be
-
Principal Investigator:
- Jan Tack, PhD, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-40 years Healthy volunteers
Exclusion Criteria:
- disease Hiv, Hepatitis B, Hepatitis C Pregnant Drug abuse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Suspension, fasted state
Suspension Noxafil will be administered in the fasted state to the volunteers.
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Experimental: Suspension, with sugar (delay gastric emptying)
Suspension will be co-administered with glucose to delay the gastric emptying time
|
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Experimental: Solution, fasted state
A solution (by acidifying the suspension in water to pH 1.2) will be administered to healthy volunteers in a fasted state.
|
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Experimental: Solution, with sugar (delaying gastric emptying)
A solution of posaconazol (by acidifying the suspension in water to pH 1.2) will be administered together with sugar to delay the gastric emptying.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Concentration-time profile in stomach and small intestine for posaconazol
Time Frame: These concentrations will be measured for 4 hours, together by taking blood samples to see how the drug will be transported to the blood circulation (PK profile for 48 hours)
|
These concentrations will be measured for 4 hours, together by taking blood samples to see how the drug will be transported to the blood circulation (PK profile for 48 hours)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- ten mL suspension of posaconazol (Noxafil) together with 240mL water will be taken by the volunteer in a fasted state
- ten mL suspension of posaconazol (Noxafil) together with 240mL water will be taken by the volunteer in a fed state
- two point six mL of suspension that is dissolved in 247mL water will be administered to the volunteer by the stomach catheter in a fasted state
- two point six mL of suspension that is dissolved in 247mL water will be administered to the volunteer by the stomach catheter in a fed state
Additional Relevant MeSH Terms
Other Study ID Numbers
- DDD13POSA
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