- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01337596
A Study of LY2951742 in Healthy Volunteers
8 octobre 2018 mis à jour par: Eli Lilly and Company
A Safety, Tolerability, and Pharmacokinetic Study of Single, Escalating Subcutaneous Doses of LY2951742 in Healthy Volunteers
To evaluate the safety and tolerability of LY2951742 given as single or multiple subcutaneous injection in healthy male subjects
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
63
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Leuven, Belgique
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 55 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Homme
La description
Inclusion Criteria:
- Are healthy Caucasian males, as determined by medical history and physical examination
- Agree to use a reliable method of birth control (e.g. condom AND additional contraception method to be used by respective partner) during the study and for 3 months following the last dose of the investigational product
- Have a body mass index (BMI) greater than 19 kilogram/square meter (kg/m^2)
- Have clinical laboratory test results within normal reference range for the population or investigator site
- Have venous access sufficient to allow for blood sampling
- Are willing to follow study procedures including no drugs (exception of study drug) 72 hours prior to initiation of the laser doppler imaging (LDI) procedure, no chocolate, alcohol or caffeine containing products 12 hours prior to initiation of the laser doppler imaging (LDI) procedure, and complete a 4 hour fast prior to initiation of the laser doppler imaging (LDI) procedure
- Have suitable skin characteristics for the dermal capsaicin challenge and have demonstrated a 100 percent increase in dermal flow following capsaicin challenge as part of the screening procedures and measured by laser doppler imaging (LDI)
Exclusion Criteria:
- Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study investigating LY2951742
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study including QTc greater than 450 milliseconds (msec) (male), history of congenital long QT syndrome or other conduction abnormality
- Have abnormal vital signs as determined by the investigator
- Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders (including migraine) that would constitute a risk when taking the study medication; or of interfering with the interpretation of data study
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of:
- Human immunodeficiency virus infection and/or positive human immunodeficiency virus (HIV) antibodies
- Hepatitis C and/or positive hepatitis C antibody
- Hepatitis B and/or positive hepatitis B surface antigen
- Intend to use over-the-counter or prescription medication that may interfere with study safety assessments or other measurements within 7 days prior to dosing and during the study (example: systemic glucocorticoids, immunomodulatory drugs, drugs with propensity for dermal reactions, and drugs with known liver toxicity).
- Have donated blood of more than 500 milliliter (mL) or has undergone major surgery
- The use of caffeine containing products and alcohol is not allowed from 12 hours prior to all study visits and during in clinic stays. All other times, alcohol consumption and caffeine intake are limited to no more than 2 alcoholic beverages or equivalent (beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits (25 milliliter [mL/1 ounce]) per day and caffeinated beverages will be limited to no more than 2 units per day amounts (1 unit=120 milligrams [mg] of caffeine). Strenuous activity is not allowed from 1 week prior to admission until the follow-up visit.
- Are smokers within the previous 6 months
- Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer)prior to dosing or have received a vaccination within 1 month
- Have a history of multiple or severe allergies or has had an anaphylactic reaction or intolerability to prescription or non-prescription drugs or food
- Are immunocompromised
- Have had cancer or within the past 5 years
- Have a history of significant allergies, in particular to ethanol or sensitivity to the fruits of capsicum plants (example: chili peppers)
- Have eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin which may interfere with the study assessments
- Cannot avoid excess tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover forearms for 24 hours prior to treatment period
- Have excessive hair growth on the volar surface of the forearm or subjects currently using lotions, oils, depilatory preparations, or other topical treatments on a regular basis which cannot be discontinued for the duration of the study; subject has used any topical treatments within 7 days of the start of the study
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Single dose 1 milligram (mg) LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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Expérimental: Single dose 5 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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Expérimental: Single dose 25 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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Expérimental: Single dose 75 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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Expérimental: Single dose 200 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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Expérimental: Single dose 600 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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Comparateur placebo: Single dose placebo
Administered single subcutaneous injection
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Administré par voie sous-cutanée
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Comparateur placebo: Multiple dose placebo
Administered subcutaneously every 2 weeks for 6 weeks (4 doses)
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Administré par voie sous-cutanée
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Expérimental: 150 mg LY2951742
Administered subcutaneously every 2 weeks for 6 weeks (4 doses)
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Administered subcutaneously
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Number of Participants With Clinically Significant Effects
Délai: Baseline up to 6 months (study completion)
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Clinically significant effects were defined as serious and other non-serious adverse events (AEs).
A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module.
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Baseline up to 6 months (study completion)
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Single Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)
Délai: Day 1 up to Day 84 or early discontinuation
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Day 1 up to Day 84 or early discontinuation
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Single Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)
Délai: Day 1 up to Day 84 or early discontinuation
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Day 1 up to Day 84 or early discontinuation
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Multiple Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)
Délai: Day 43 up to Day 57
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Day 43 up to Day 57
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Multiple Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)
Délai: Day 43 up to Day 57
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Day 43 up to Day 57
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2011
Achèvement primaire (Réel)
1 avril 2012
Achèvement de l'étude (Réel)
1 avril 2012
Dates d'inscription aux études
Première soumission
15 avril 2011
Première soumission répondant aux critères de contrôle qualité
15 avril 2011
Première publication (Estimation)
19 avril 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 février 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 octobre 2018
Dernière vérification
1 mai 2012
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 14248
- I5Q-MC-CGAA (Autre identifiant: Eli Lilly and Company)
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 .