- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02319057
Pharmacokinetic Study of Single Doses of ORM-12741 (Nebula PK 1)
Pharmacokinetic Study of Modified Release Formulations and an Immediate Release Formulation of ORM-12741 After Single Oral Doses
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
-
Turku, Finlande
- Clinical Research Services Turku, CRST
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Written informed consent (IC) obtained.
- Good general health ascertained by detailed medical history and physical examination.
- Females and males between 18 and 65 years of age (inclusive).
- Body mass index (BMI) between 18-30 kg/m2 (inclusive, BMI = weight/height2).
- Weight of 50-100 kg (inclusive).
- Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems).
Exclusion Criteria:
- Predicted poor compliance or inability to communicate well with the investigator or the study centre personnel.
- Veins unsuitable for repeated venipuncture or cannulation.
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator.
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. Hormonal contraception and hormone replacement therapy are allowed.
- Susceptibility to severe allergic reactions.
- Intake of any medication that could affect the outcome of the study, within 2 weeks prior to the first study treatment administration or less than 5 times the half-life of the medication. Possible enzyme inducing drugs will be discussed case-by-case with the sponsor.
- Regular consumption of more than 21 units of alcohol per week for males and 16 units per week for females (1 unit = 4 cl spirits, about 13 g of alcohol).
- Current use of nicotine-containing products more than 5 cigarettes or equivalent/day.
- Inability to refrain from using nicotine-containing products during the stay at the study centre.
- Inability to refrain from consuming caffeine-containing beverages during the stay at the study centre, e.g. propensity to develop headaches when refraining from caffeine-containing beverages.
- Blood donation or loss of significant amount of blood within 3 months prior to the first study treatment administration.
Any clinically significant 12-lead electrocardiogram (ECG) abnormality after a 10-minute rest in supine position at the screening visit, as judged by the investigator. For example:
- QTc (calculated with the Bazett's formula) > 470 msec for females and 450 msec for men.
- HR < 45 beats/minute or > 100 beats/minute after a 10-minute rest in supine position at the screening visit.
At the screening visit systolic blood pressure (BP) < 90 mmHg or > 150 mmHg after a 10- minute rest in supine position, diastolic BP < 50 mmHg or > 90 mmHg after a 10-minute rest in supine position, or symptomatic orthostatic hypotension, or
- decrease of ≥ 20 mmHg of systolic BP or
- decrease of ≥ 10 mmHg of diastolic BP after 3 minutes in standing position.
- Any abnormal value in laboratory tests, or vital signs, or physical examination finding, which in the opinion of the investigator could interfere with the interpretation of the test results or cause a health risk for the subject if he takes part in the study.
- History of drug abuse or positive result in drug abuse test.
- Positive serology to human immunodeficiency virus antibodies (HIVAgAb), hepatitis C virus antibodies (HCVAb) or hepatitis B surface antigen (HBsAg).
- Females of childbearing potential if they are not using proper contraception (hormonal contraception, intrauterine device [IUD] or surgical sterilization, spermicidal foam in conjunction with condom on male partner) during the study. Use of oral/hormonal contraception alone is not acceptable. (Note: women of childbearing potential with no current heterosexual relationship can be included without contraception according to the judgement of the investigator).
- Any other condition that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health risk for the study subject.
- Participation in a clinical drug study within 3 months prior to the first study treatment administration of this study or earlier participation in a clinical study with ORM-12741.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Panel 1
Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these
|
Formulation à libération modifiée d'ORM-12741
Formulation à libération modifiée d'ORM-12741
Immediate release formulation of ORM-12741
|
Expérimental: Panel 2
Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these
|
Formulation à libération modifiée d'ORM-12741
Formulation à libération modifiée d'ORM-12741
Immediate release formulation of ORM-12741
|
Expérimental: Panel 3
Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these
|
Formulation à libération modifiée d'ORM-12741
Formulation à libération modifiée d'ORM-12741
Immediate release formulation of ORM-12741
|
Expérimental: Panel 4
Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these
|
Formulation à libération modifiée d'ORM-12741
Formulation à libération modifiée d'ORM-12741
Immediate release formulation of ORM-12741
|
Expérimental: Panel 5
Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these
|
Formulation à libération modifiée d'ORM-12741
Formulation à libération modifiée d'ORM-12741
Immediate release formulation of ORM-12741
|
Expérimental: Panel 6
Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these
|
Formulation à libération modifiée d'ORM-12741
Formulation à libération modifiée d'ORM-12741
Immediate release formulation of ORM-12741
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Pharmacokinetics
Délai: Blood samples collected frequently on day 1 and once or twice a day for 4 days
|
Explore the PK profile (e.g.
Cmax, tmax, AUC, t1/2) and determine protein binding
|
Blood samples collected frequently on day 1 and once or twice a day for 4 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values
Délai: 24 hours per period
|
adverse events, vital signs, ECG, safety laboratory values
|
24 hours per period
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 3098011
- 2014-000193-19 (Numéro EudraCT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur En bonne santé
-
AstraZenecaParexelComplété
Essais cliniques sur ORM-12741 M. A
-
Orion Corporation, Orion PharmaComplété
-
Orion Corporation, Orion PharmaComplétéEn bonne santéFrance
-
Orion Corporation, Orion PharmaComplétéEn bonne santéFrance
-
Orion Corporation, Orion PharmaComplété
-
Orion Corporation, Orion PharmaJanssen PharmaceuticalsComplétéLa maladie d'AlzheimerFinlande
-
Orion Corporation, Orion PharmaComplétéEn bonne santéFrance
-
Orion Corporation, Orion PharmaComplétéVolontaires masculins en bonne santéPays-Bas
-
Orion Corporation, Orion PharmaComplétéVolontaires en bonne santéFinlande
-
University of Cape TownUniversity of Oxford; Orion Corporation, Orion PharmaComplétéVolontaire en bonne santéAfrique du Sud