Clinical Trial Results:
Supersaturation and precipitation of ritonavir in the gastrointestinal tract of healthy volunteers
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Summary
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EudraCT number |
2016-002700-78 |
Trial protocol |
BE |
Global end of trial date |
27 Aug 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Apr 2021
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First version publication date |
28 Apr 2021
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Other versions |
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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 |
DDD16RITONAVIR
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Clinical Trial Center UZ Leuven: S59578 | ||
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Sponsors
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Sponsor organisation name |
Drug Delivery and Disposition
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Sponsor organisation address |
Herestraat 49, Leuven, Belgium,
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Public contact |
Drug Delivery and Disposition, KU Leuven, +32 16379105, jens.vandenabeele@kuleuven.be
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Scientific contact |
Drug Delivery and Disposition, KU Leuven, +32 16379105, jens.vandenabeele@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 |
25 May 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Aug 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Aug 2018
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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 |
To evaluate the gastrointestinal behaviour of a weakly basic drug (ritonavir) in healthy volunteers and its implications for systemic drug exposure
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Protection of trial subjects |
Identification of trial subjects was replaced by study participant numbers
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
13 Feb 2017
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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 |
- | |||||||||
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Pre-assignment
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Screening details |
Candidate volunteers were excluded from participation in case of he-patitis B/C and/or HIV infection, illness at the time of the trial, medi-cation use, a history of acute/chronic gastrointestinal disease(s), (pos-sible) pregnancy, and/or frequent exposure to radiation during theprevious year. | |||||||||
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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 |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Ritonavir | |||||||||
Arm description |
Oral intake of one Norvir®tablet (100 mg ritonavir) with 240 mL oftap water under fasted state conditions | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Ritonavir
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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 |
Oral intake of one Norvir®tablet (100 mg ritonavir) with 240 mL oftap water under fasted state conditions
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Arm title
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Ritonavir + PPI | |||||||||
Arm description |
Oral intake of one Norvir®tablet (100 mg ritonavir) with 240 mL oftap water under fasted state conditions after intake of a proton-pump inhibitor (PPI) once-daily, starting 48 hours before the start ofthe study (Nexium®, 40 mg esomeprazole) | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Ritonavir + esomeprazole
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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 |
ral intake of one Norvir®tablet (100 mg ritonavir) with 240 mL oftap water under fasted state conditions after intake of a proton-pump inhibitor (PPI) once-daily, starting 48 hours before the start ofthe study (Nexium®, 40 mg esomeprazole)
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial (overall period)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Ritonavir
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Reporting group description |
Oral intake of one Norvir®tablet (100 mg ritonavir) with 240 mL oftap water under fasted state conditions | ||
Reporting group title |
Ritonavir + PPI
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Reporting group description |
Oral intake of one Norvir®tablet (100 mg ritonavir) with 240 mL oftap water under fasted state conditions after intake of a proton-pump inhibitor (PPI) once-daily, starting 48 hours before the start ofthe study (Nexium®, 40 mg esomeprazole) | ||
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End point title |
Solubility in the stomach [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Visit 1 - visit 2
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No p values mentioned only description of the measured values. |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Visit 1 - visit 2
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
23
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| 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: No adverse events reported in the 5 HV |
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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. | |||
| None reported | |||
