A Study of LY3322207 in Healthy Participants and in Participants With Hypertension (High Blood Pressure)
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
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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Groningen, Holandia, 9728 NZ
- PRA Health Sciences
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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- Have previously completed or withdrawn from this study or any other study investigating this study drug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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
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Eksperymentalny: LY3322207 (Part A)
LY3322207 administered subcutaneously (SC)
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Administered by SC injection
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Komparator placebo: Placebo (Part A)
Placebo matching LY3322207 administered SC
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Podawany przez wstrzyknięcie SC
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Eksperymentalny: LY3322207 (Part B)
LY3322207 administered SC once weekly
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Administered by SC injection
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Komparator placebo: Placebo (Part B)
Placebo matching LY3322207 administered SC once weekly
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Podawany przez wstrzyknięcie SC
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Eksperymentalny: LY3322207 (Part C)
LY3322207 administered SC in participants with hypertension
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Administered by SC injection
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Participants with One or More Serious Adverse Events (Part A)
Ramy czasowe: Baseline up to approximately 31 days
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Serious and other non-serious adverse events will be reported in the Adverse Events Module
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Baseline up to approximately 31 days
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Number of Participants with One or More Serious Adverse Events (Part B)
Ramy czasowe: Baseline up to approximately 9 weeks
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Serious and other non-serious adverse events will be reported in the Adverse Events Module
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Baseline up to approximately 9 weeks
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Number of Participants with One or More Serious Adverse Events (Part C)
Ramy czasowe: Baseline up to approximately 9 weeks
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Serious and other non-serious adverse events will be reported in the Adverse Events Module
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Baseline up to approximately 9 weeks
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part A)
Ramy czasowe: Predose up approximately 31 days
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Pharmacokinetics (PK): AUC of LY3322207
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Predose up approximately 31 days
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Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part B)
Ramy czasowe: Predose up to approximately 9 weeks
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PK: AUC of LY3322207
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Predose up to approximately 9 weeks
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Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part C)
Ramy czasowe: Predose up to approximately 9 weeks
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PK: AUC of LY3322207
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Predose up to approximately 9 weeks
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Maximum Concentration (Cmax) of LY3322207 (Part A)
Ramy czasowe: Predose up approximately 31 days
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PK: Cmax of LY3322207
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Predose up approximately 31 days
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Maximum Concentration (Cmax) of LY3322207 (Part B)
Ramy czasowe: Predose up to approximately 9 weeks
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PK: Cmax of LY3322207
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Predose up to approximately 9 weeks
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Maximum Concentration (Cmax) of LY3322207 (Part C)
Ramy czasowe: Predose up to approximately 9 weeks
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PK: Cmax of LY3322207
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Predose up to approximately 9 weeks
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Time to reach Cmax (Tmax) of LY3322207 (Part A)
Ramy czasowe: Predose up to approximately Day 31
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PK: Tmax of LY3322207
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Predose up to approximately Day 31
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Time to reach Cmax (Tmax) of LY3322207 (Part B)
Ramy czasowe: Predose up to approximately 9 weeks
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PK: Tmax of LY3322207
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Predose up to approximately 9 weeks
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Time to reach Cmax (Tmax) of LY3322207 (Part C)
Ramy czasowe: Predose up to approximately 9 weeks
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PK: Tmax of LY3322207
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Predose up to approximately 9 weeks
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Change from Baseline in Systolic Blood Pressure (SBP) (Part A)
Ramy czasowe: Baseline up approximately 31 days
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Supine position
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Baseline up approximately 31 days
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Change from Baseline in Systolic Blood Pressure (SBP) (Part B)
Ramy czasowe: Baseline up to approximately 9 weeks
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Supine position
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Baseline up to approximately 9 weeks
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Change from Baseline in Systolic Blood Pressure (SBP) (Part C)
Ramy czasowe: Baseline up to approximately 9 weeks
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Supine position
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Baseline up to approximately 9 weeks
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Change from Baseline in Diastolic Blood Pressure (DBP) (Part A)
Ramy czasowe: Baseline up approximately 31 days
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Supine position
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Baseline up approximately 31 days
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Change from Baseline in Diastolic Blood Pressure (DBP) (Part B)
Ramy czasowe: Baseline up to approximately 9 weeks
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Supine position
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Baseline up to approximately 9 weeks
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Change from Baseline in Diastolic Blood Pressure (DBP) (Part C)
Ramy czasowe: Baseline up to approximately 9 weeks
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Supine position
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Baseline up to approximately 9 weeks
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Change from Baseline in Heart Rate (Part A)
Ramy czasowe: Baseline up approximately 31 days
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Supine position
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Baseline up approximately 31 days
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Change from Baseline in Heart Rate (Part B)
Ramy czasowe: Baseline up to approximately 9 weeks
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Supine position
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Baseline up to approximately 9 weeks
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Change from Baseline in Heart Rate (Part C)
Ramy czasowe: Baseline up to approximately 9 weeks
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Supine position
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Baseline up to approximately 9 weeks
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Współpracownicy i badacze
Sponsor
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 16771
- I9K-MC-UCAA (Inny identyfikator: Eli Lilly and Company)
- 2018-002337-38 (Numer EudraCT)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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