- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03590860
A Study of LY3322207 in Healthy Participants and in Participants With Hypertension (High Blood Pressure)
22 février 2019 mis à jour par: Eli Lilly and Company
A Safety, Tolerability, and Pharmacokinetic Study of Single and Multiple Ascending Doses of LY3322207 in Healthy Subjects and Subjects With Hypertension on ACE I/ARB Therapy
The purpose of this study is to investigate the safety of the study drug known as LY3322207.
Participants must be healthy or must have hypertension (high blood pressure).
Participants with hypertension may already be taking a common drug to reduce blood pressure called an angiotensin-converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB).
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
62
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
-
-
-
Groningen, Pays-Bas, 9728 NZ
- PRA Health Sciences
-
-
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 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Healthy males, as determined by medical history and physical examination, must agree to use a medically appropriate method of birth control and agree not to donate sperm from start of dosing until 90 days beyond last dose
Healthy females, as determined by medical history and physical examination, of non-child bearing potential due to:
- Menopause: spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications that induced the amenorrhea (for example: oral contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy)
- Surgical sterilization
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow site specific study procedures
- Have a Body Mass Index (BMI) 18 to 30 kilogram per square meter (kg/m²) at entry
- Have clinical laboratory test results within normal reference range for the population or site, or results with acceptable deviations that are judged not clinically significant
- Be 18 to 55 years old for either Part A or Part B of the study, or 18 to 65 years old for Part C only
- For Part C: must have been treated with a stable dose of ACE-I or ARB for at least 1 month
Exclusion Criteria:
- Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational drug that has not received regulatory approval
- Have previously completed or withdrawn from this study or any other study investigating this study drug
- Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, significant atopy, or any clinically significant laboratory abnormality that would preclude study participation
- Have abnormality in the 12-lead electrocardiogram (ECG) which increases study risk
- Have confirmed QT interval corrected by Bazett's method (QTcB) or Fridericia's (QTcF) method >450 millisecond (msec) for men and >470 msec for women
- Have prior Q-wave myocardial infarction or other, specific heart abnormalities, arrhythmias or fibrillations
- Have an abnormal blood pressure (supine) defined as diastolic blood pressure greater than (>)95 or less than (<)50 millimeters of mercury (mmHg) and/or systolic blood pressure >160 or <90 mmHg
- Show evidence of human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
- Have donated blood of more than 100 mL (milliliters) within the last month
- Are unwilling to stop alcohol consumption while resident in the Clinical Research Unit
- Have an average weekly alcohol intake that exceeds 21 units per week (1 unit equal to (=) 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
- Have an abnormal blood pressure (supine) defined as diastolic blood pressure >95 or <50 mmHg and/or systolic blood pressure >160 or <90 mmHg
- Have serum potassium outside normal range
- Have had lymphoma, leukemia, or any malignancy within the past 5 years
- Have clinically significant multiple or severe drug allergies or intolerance
- Are lactating women
- Positive findings for known drugs of abuse
- Have received treatment with biologic agents within 3 months or 5 half-lives prior to dosing
- Participation in any other clinical trial involving a study drug or off-label use of a drug or device, or any other type of medical research judged not to be compatible with this study
- Have estimated glomerular filtration rate (eGFR) < 60 milliliters per minute per 1.73 square meter (mL/min/1.73 m²) for Parts A and B of this study, or eGFR < 50 mL/min/1.73 m² in Part C only
- For Part C: have a history of severe hypertension (defined as SBP greater than or equal to (≥)180 mmHg and/or DBP ≥120 mmHg), secondary hypertension, symptomatic postural hypotension, or hospitalization due to hypertension
- For Part C: have a history of supraventricular tachycardia (for example, atrial fibrillation), ventricular tachycardia, or other cardiac arrhythmia
- For Part C: have resting tachycardia (heart rate ≥100 beats per minute)
- For Part C: have New York Heart Association (NYHA) Class II, III, or IV heart failure, or had any of the following in the previous 3 months: coronary angioplasty, coronary stent placement, coronary bypass surgery or any significant cardiac surgery, myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack
- For Part C: have an automatic internal cardioverter-defibrillator
- For Part C: have diabetes
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: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: LY3322207 (Part A)
LY3322207 administered subcutaneously (SC)
|
Administered by SC injection
|
Comparateur placebo: Placebo (Part A)
Placebo matching LY3322207 administered SC
|
Administré par injection SC
|
Expérimental: LY3322207 (Part B)
LY3322207 administered SC once weekly
|
Administered by SC injection
|
Comparateur placebo: Placebo (Part B)
Placebo matching LY3322207 administered SC once weekly
|
Administré par injection SC
|
Expérimental: LY3322207 (Part C)
LY3322207 administered SC in participants with hypertension
|
Administered by SC injection
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of Participants with One or More Serious Adverse Events (Part A)
Délai: Baseline up to approximately 31 days
|
Serious and other non-serious adverse events will be reported in the Adverse Events Module
|
Baseline up to approximately 31 days
|
Number of Participants with One or More Serious Adverse Events (Part B)
Délai: Baseline up to approximately 9 weeks
|
Serious and other non-serious adverse events will be reported in the Adverse Events Module
|
Baseline up to approximately 9 weeks
|
Number of Participants with One or More Serious Adverse Events (Part C)
Délai: Baseline up to approximately 9 weeks
|
Serious and other non-serious adverse events will be reported in the Adverse Events Module
|
Baseline up to approximately 9 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part A)
Délai: Predose up approximately 31 days
|
Pharmacokinetics (PK): AUC of LY3322207
|
Predose up approximately 31 days
|
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part B)
Délai: Predose up to approximately 9 weeks
|
PK: AUC of LY3322207
|
Predose up to approximately 9 weeks
|
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part C)
Délai: Predose up to approximately 9 weeks
|
PK: AUC of LY3322207
|
Predose up to approximately 9 weeks
|
Maximum Concentration (Cmax) of LY3322207 (Part A)
Délai: Predose up approximately 31 days
|
PK: Cmax of LY3322207
|
Predose up approximately 31 days
|
Maximum Concentration (Cmax) of LY3322207 (Part B)
Délai: Predose up to approximately 9 weeks
|
PK: Cmax of LY3322207
|
Predose up to approximately 9 weeks
|
Maximum Concentration (Cmax) of LY3322207 (Part C)
Délai: Predose up to approximately 9 weeks
|
PK: Cmax of LY3322207
|
Predose up to approximately 9 weeks
|
Time to reach Cmax (Tmax) of LY3322207 (Part A)
Délai: Predose up to approximately Day 31
|
PK: Tmax of LY3322207
|
Predose up to approximately Day 31
|
Time to reach Cmax (Tmax) of LY3322207 (Part B)
Délai: Predose up to approximately 9 weeks
|
PK: Tmax of LY3322207
|
Predose up to approximately 9 weeks
|
Time to reach Cmax (Tmax) of LY3322207 (Part C)
Délai: Predose up to approximately 9 weeks
|
PK: Tmax of LY3322207
|
Predose up to approximately 9 weeks
|
Change from Baseline in Systolic Blood Pressure (SBP) (Part A)
Délai: Baseline up approximately 31 days
|
Supine position
|
Baseline up approximately 31 days
|
Change from Baseline in Systolic Blood Pressure (SBP) (Part B)
Délai: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
Change from Baseline in Systolic Blood Pressure (SBP) (Part C)
Délai: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part A)
Délai: Baseline up approximately 31 days
|
Supine position
|
Baseline up approximately 31 days
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part B)
Délai: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part C)
Délai: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
Change from Baseline in Heart Rate (Part A)
Délai: Baseline up approximately 31 days
|
Supine position
|
Baseline up approximately 31 days
|
Change from Baseline in Heart Rate (Part B)
Délai: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
Change from Baseline in Heart Rate (Part C)
Délai: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
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 (Réel)
13 juillet 2018
Achèvement primaire (Réel)
17 janvier 2019
Achèvement de l'étude (Réel)
17 janvier 2019
Dates d'inscription aux études
Première soumission
6 juillet 2018
Première soumission répondant aux critères de contrôle qualité
6 juillet 2018
Première publication (Réel)
18 juillet 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 février 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 février 2019
Dernière vérification
1 février 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 16771
- I9K-MC-UCAA (Autre identifiant: Eli Lilly and Company)
- 2018-002337-38 (Numéro EudraCT)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Oui
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 Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecrutementHypertension Essentielle | Hypertension, masquéTaïwan
-
University of Alabama at BirminghamTroy UniversityComplétéHypertension | Hypertension, résistante à la thérapie conventionnelle | Hypertension non contrôlée | Hypertension, blouse blancheÉtats-Unis
-
Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and DevelopmentInconnue
-
Centre Chirurgical Marie LannelongueInconnueHypertension pulmonaire thromboembolique chronique et hypertension artérielle pulmonaireFrance
-
Vanderbilt University Medical CenterJohns Hopkins UniversityComplétéHypertension artérielle pulmonaire | Hypertension artérielle pulmonaire idiopathique | Hypertension artérielle pulmonaire associée | Hypertension artérielle pulmonaire héréditaireÉtats-Unis
-
Assistance Publique - Hôpitaux de ParisActif, ne recrute pasHypertension portale non cirrhotique intrahépatiqueFrance
-
University of Kansas Medical CenterRecrutementHypertension artérielle pulmonaire | Hypertension pulmonaire | Hypertension pulmonaire thromboembolique chronique | Hypertension pulmonaire due à une cardiopathie gauche | Hypertension pulmonaire, primaire, 4 | Hypertension pulmonaire, primaire, 2 | Hypertension pulmonaire, primaire, 3 | Hypertension... et d'autres conditionsÉtats-Unis
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldComplétéHypertension artérielle pulmonaire idiopathique | Hypertension pulmonaire thromboembolique chroniqueRoyaume-Uni
-
BayerComplété
-
AstraZenecaComplétéHypertension artérielle (hypertension).
Essais cliniques sur Placebo
-
SamA Pharmaceutical Co., LtdInconnueBronchite aiguë | Infection aiguë des voies respiratoires supérieuresCorée, République de
-
National Institute on Drug Abuse (NIDA)ComplétéConsommation de cannabisÉtats-Unis
-
Heptares Therapeutics LimitedComplétéPharmacocinétique | Des problèmes de sécuritéRoyaume-Uni
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyComplétéSujets masculins atteints de diabète de type II (T2DM)Allemagne
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingComplétéMaladie de ParkinsonChine
-
ItalfarmacoComplétéDystrophie musculaire de BeckerPays-Bas, Italie
-
Guangdong Zhongsheng Pharmaceutical Co., Ltd.Complété
-
West Penn Allegheny Health SystemComplétéAsthme | Rhinite allergiqueÉtats-Unis
-
Regado Biosciences, Inc.ComplétéVolontaire en bonne santéÉtats-Unis