E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A) healthy volunteers (transcapillary escape rate of albumin, plasmavolume, and turnover of albumin)
B) Acute inflammation such as pancreatitis or cholecystitis
C) Scheduled major abdominal surgery such as pancreatico- duodenectomy in pancreatic cancer |
A) Friska frivilliga forskningspersoner (kapillärläckage, plasmavolym och omsättningshastighet för albumin)
B) Akut inflammation exempelvis pankreatit eller cholecystit
C) Planerad stor kirurgi exempelvis Whipple´s op av pankreascancer |
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E.1.1.1 | Medical condition in easily understood language |
A) healthy volunteers
B) Acute inflammation such as pancreatitis or cholecystitis
C) Scheduled major abdominal surgery such as pancreatico- duodenectomy in pancreatic cancer |
A) Friska frivilliga forskningspersoner
B) Hastigt påkommen inflammation av exempelvis bukspottkörtel eller gallblåsa
C) Planerad stor bukkirurgi till exempel operation för cancer i bukspottkörteln |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Do the extempore made tracer 123-iodine labeled albumin an commercially manufactured SERALB-125 give identicla values of calculated blood plasma volume and capillary leakage meassured as transcapillary escape rate of albumin? |
Är mätvärdena för den extempore beredda tracern 123-jodmärkt albumin och kommersiella SERALB-125 identiska avseende beräknad plasmavolym respektive transkapillärt läckage av albumin? |
|
E.2.2 | Secondary objectives of the trial |
How do three different meassures of albumin turnover correlatein volunteers?
How do the pharmacokinetic parameters of endogenous albumin vary between the three study groups? |
Hur starkt korrelerar tre olika mätningar av albumins omsättningshastighet hos voluntärer?
Hur varierar de olika farmakokinetiska parametrarna för albumin mellan de tre olika studiegrupperna? |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A) INCLUSION CRITERIA VOLUNTEERS
- Healthy volunteers, men and women ≥ 40 years
- Anticonception for fertile women
- Good peripheral blood vessels
- Written informed consent
B) INCLUSION CRITERIA PATIENTS WITH ACUTE INFLAMMATION
- Severe inflammation such as acute pankreatitis or acute cholecystitis
- Men and women ≥ 40 years
- Written informed consent
C) INCLUSION CRITERIA ELECTIVE SURGICAL PATIENTS
- Scheduled major abdominal surgery such as pancreatectomy
- Men and women ≥ 40 years
- Written informed consent
|
A) INKLUSIONSKRITERIER FORSKNINGSPERSONER
- Friska frivilliga forskningspersoner, män och kvinnor ≥ 40 år
- Tillförlitlig antikonception för kvinnor
- Goda perifera blodkärl
- Signerat skriftligt samtycke
B) INKLUSIONSKRITERIER AKUT INFLAMMERADE PATIENTER
- Kraftig inflammation t ex akut pankreatit eller akut cholecystit
- Män och kvinnor ≥ 40 år
- Signerat skriftligt samtycke
C) INKLUSIONSKRITERIER ELEKTIVA KIRURGISKA PATIENTER
- Planerad stor kirurgi t ex pankreaskirurgi
- Män och kvinnor ≥ 40 år
- Signerat skriftligt samtycke
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E.4 | Principal exclusion criteria |
EXCLUSION CRITERIA ALL GROUPS (A-C)
- Pregnancy or nursing
- Allergy to the investigational medical products
- Participation in any other study commencing radiation or stable isotopes within 60 days
- Any circumstance that in the judgement of the investigator makes the participation of the volunteer or patient unsuitable.
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EXKLUSIONSKRITERIER ALLA GRUPPER (A-C)
- Graviditet eller amning
- Allergi mot prövningsläkemedlet
- Deltagande i annan studie med strålning eller stabila isotoper inom 60 dagar
- Omständighet som gör att ansvarig forskare bedömer patientens eller forskningspersonens deltagande såsom olämpligt
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Transcapillary escape rate for albumin
2) Plasma volume |
1) Transkkapillär läckagehastighet av albumin
2) Plasmavolym |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 and 2) Blood sampling for 90 min from isotope injection |
1 och 2) Blodprovstagning under 90 minuter från isotopinjektion |
|
E.5.2 | Secondary end point(s) |
1) Plasma albumin (P-albumin)
2) Fractional syntesis rate of albumin (FSR)
3) Fractional catabolic rate for albumin over 24 hours (FCR1, only in volunteers)
4) Fractional catabolic rate meassured over the whole study period (FCR30, onlyu in volunteers)
5) Absolute synthesis rate of albumin (ASR) |
1) Plasma-albumin (P-albumin)
2) Fraktionell synteshastighet för albumin (FSR)
3) Fraktionell katabol hastighet för albumin över 1 dygn (FCR1, bara hos voluntärer)
4) Fraktionell katabol hastighet mätt över hela mätperioden (FCR30, bara hos voluntärer)
5) Absolut synteshastighet för albumin (ASR) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Same numbers as above
1) All blood samples until 42 dagar (volunteers) or 90+90 min (patients)
2) Blood samples during 90 min after injection of stable isotope
3) Urine collection for 24 hours (day 6, 13, 20)
4) Blood samples up to 42 days
5) Calculated from P-albumin and plasma volume i.e. sampling for 90 min |
Samma nummer som ovan
1) Alla blodprover upp till 42 dagar (voluntärer) eller 90+90 minuter (patienter)
2) Blodprover under 90 minuter efter att stabil isotop getts
3) Urinsamling under 1 dygn (dag 6, 13, 20)
4) Blodprover under hela studieperioden upp till 42 dagar
5) Beräknas ur P-albumin och plasmavolym dvs prover under 90 min |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
This is a validation study of a extempore made tracer compared with a commercial.
Tracer studies have no medcial effects but are used for studying human physiology, in this case pharmacokinetic variables of endogenous albumin distribution and turnover at different levels of inflammation. |
Valideringsstudie av egentillverkad tracer som jämförs med en kommersiell.
Tracerstudier har inga egna effekter utan det är fysiologi som studeras, i detta fall farmakokinetiska variabler av endogen albumindistribution och omsättning vid olika grader av inflammation. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The study is completed when we have collected data from 10 evaluable subjects in each study group |
Studien avslutas när vi samlat data från 10 evaluerbara deltagare i varje grupp. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |