E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Determination of pharmacokinetics and safety of tacrolimus in adolescents with plaque psoriasis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
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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 |
The main objective of the trial is to dertermine the pharmacokinetics and safety of tacrolimus in adolescents (≥ 12 to ≤ 17 years of age) with plaque psoriasis who will be treated topically for 19 days with tacrolimus cream B 0.1%. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject/Parent or Guardian has provided IRB/IEC- approved written assent (minors) or consent (parents/guardian) Subject is ≥ 12 to ≤ 17 years of age Subject has a diagnosis of plaque psoriasis and has a Physician's Static Global Assessment Score of ≥ 3 Body Surface Area (BSA) of plaque psoriasis-covered skin collectively accounts for ≥ 10% BSA, not including the scalp Negative pregancy test Sexually active females must agree to use contraception/birth control measures while on study and during pre-study washout
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E.4 | Principal exclusion criteria |
Subject has genodermatosis that results in a defective epidermal barrier function (e.g., Netherton Syndrom) Subject has another skin disorder (including infection) in the treatment area Subject has pustular or erythrodermic psoriasis Subject has known hypersensitivity to macrolides or any excipient of the drug Subject has a chronic condition (e.g. diabetes, hypertension) which is not stable and/ or well controlled Subject has a history or presence of malignancy (including skin cancer), immuno-deficiency syndrome, serious active or recurrent infection, or any medical condition or disorder that, in the opinion of the investigator, precludes the subject from participating in the study, or being compliant |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetics based on the following model-independent PK parameters: AUC0-24, AUC0-12, AUC0-t, Cavg, Cmax, Tmax.
Safety based on repoprting of Aes, physical examination, vital signs and clinical laboratory evaluations. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
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) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |