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Pharmacokinetic study of rectal and ublingual administration of tacrolimus in healthy volunteers.


- candidate number9122
- NTR NumberNTR2758
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2011
- Secondary IDs11-2-004 / DRUM11-TACR; MEC azM/UM / Drug Research Unit Maastricht
- Public TitlePharmacokinetic study of rectal and ublingual administration of tacrolimus in healthy volunteers.
- Scientific TitlePharmacokinetic study of rectal and ublingual administration of tacrolimus in healthy volunteers.
- ACRONYMRectal and sublingual administration of tacrolimus
- hypothesisThe primary objective is to compare the pharmacokinetic profile of tacrolimus after rectal and sublingual administration with oral administration.
- Healt Condition(s) or Problem(s) studiedTacrolimus, Pharmacokinetics, Rectal, Sublingual
- Inclusion criteria1. Legally capacitated;
2. 18-65 years old;
3. Using adequate contraception (female volunteers of childbearing potential);
4. Able to comply with the study protocol and willing to give written informed consent.
- Exclusion criteria1. Concomitant use of medication, grapefruit juice or St John’s worth;
2. Smoking 10 or more cigarettes per day;
3. Simultaneous participation in another clinical trial;
4. Pregnancy or lactation (female volunteers);
5. Abnormal liver biochemistry (>2x upper normal limit);
6. Renal insufficiency (estimated creatinin clearance according to Cockroft-Gault < 70 mL/min);
7. Blood pressure > 160/100 mmHg, measured after at least 10 min rest in semi-recumbent position;
8. Prolonged QT interval, corrected for heart rate using the Bazett’s formula (women>470 ms, men>450 ms);
9. Active infection, as determined by clinical examination.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2011
- planned closingdate1-mei-2011
- Target number of participants18
- InterventionsThree single doses of tacrolimus will be administered in randomized order with an interval of at least 1 week:
1. A sublingual dose of 3 mg;
2. A rectal dose of 15 mg;
3. An oral dose of 7 mg.
Venous blood samples are drawn at prespecified time points.
- Primary outcomeArea under the blood concentration of tacrolimus – time curve (AUC).
- Secondary outcomeRelative bioavailability (F) for rectal and sublingual administration compared to oral administration of tacrolimus, time point after administration at which maximal blood concentration of tacrolimus is reached (tmax) and elimination rate constant (kel) for tacrolimus.
- TimepointsThree single doses of tacrolimus will be administered in randomized order with an interval of at least 1 week.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M.H.L. Christiaans
- CONTACT for SCIENTIFIC QUERIESDr. M.H.L. Christiaans
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- Publicationsvan de Plas, A., et al., Pilotstudy naar farmacokinetiek bij sublinguale en rectale toediening van tacrolimus. Pharm Weekbl 2008. 2(3): p. 66-8.
- Brief summaryRationale:
Tacrolimus is an immunosuppressant drug that is used to prevent rejection of transplanted donor organs. Both oral and intravenous routes of administration are currently used in clinical practice. A need exists for alternative routes of administration, such as rectal or sublingual administration. These routes of administration have not been adequately assessed.

Objective:
To compare the pharmacokinetic profile of tacrolimus after rectal (suppository) and sublingual (powder) administration with oral (capsule) administration.

Study design:
Open, stratified, randomized, 3-way cross-over trial.

Study population:
Eighteen healthy volunteers, 18-65 years old.

Intervention:
Three single doses of tacrolimus will be administered in randomized order with an interval of at least 1 week:
1. A sublingual dose of 3 mg;
2. A rectal dose of 15 mg;
3. An oral dose of 7 mg.
Venous blood samples are drawn at prespecified time points.

Main study parameters/endpoints:
The area under the blood concentration-time curve (AUC) is used as main study parameter.
Secondary parameters are: Relative bioavailability, the time after administration when the maximum blood concentration is reached (tmax) and the elimination rate constant (kel).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The safety of single doses of tacrolimus has been well established. Volunteers may experience tacrolimus-related adverse effects. These adverse effects are generally mild and transient. During the trial, 42 venous blood samples are taken (a total of 196 ml blood). The trial comprises of 9 site visits. Volunteers will not benefit directly from participation.
- Main changes (audit trail)
- RECORD16-feb-2011 - 11-mrt-2011


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