- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03590860
A Study of LY3322207 in Healthy Participants and in Participants With Hypertension (High Blood Pressure)
22. Februar 2019 aktualisiert von: 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).
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
62
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Groningen, Niederlande, 9728 NZ
- PRA Health Sciences
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: LY3322207 (Part A)
LY3322207 administered subcutaneously (SC)
|
Administered by SC injection
|
|
Placebo-Komparator: Placebo (Part A)
Placebo matching LY3322207 administered SC
|
Verabreicht durch SC-Injektion
|
|
Experimental: LY3322207 (Part B)
LY3322207 administered SC once weekly
|
Administered by SC injection
|
|
Placebo-Komparator: Placebo (Part B)
Placebo matching LY3322207 administered SC once weekly
|
Verabreicht durch SC-Injektion
|
|
Experimental: LY3322207 (Part C)
LY3322207 administered SC in participants with hypertension
|
Administered by SC injection
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants with One or More Serious Adverse Events (Part A)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part A)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Predose up to approximately 9 weeks
|
PK: AUC of LY3322207
|
Predose up to approximately 9 weeks
|
|
Maximum Concentration (Cmax) of LY3322207 (Part A)
Zeitfenster: Predose up approximately 31 days
|
PK: Cmax of LY3322207
|
Predose up approximately 31 days
|
|
Maximum Concentration (Cmax) of LY3322207 (Part B)
Zeitfenster: Predose up to approximately 9 weeks
|
PK: Cmax of LY3322207
|
Predose up to approximately 9 weeks
|
|
Maximum Concentration (Cmax) of LY3322207 (Part C)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Baseline up approximately 31 days
|
Supine position
|
Baseline up approximately 31 days
|
|
Change from Baseline in Systolic Blood Pressure (SBP) (Part B)
Zeitfenster: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Systolic Blood Pressure (SBP) (Part C)
Zeitfenster: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part A)
Zeitfenster: Baseline up approximately 31 days
|
Supine position
|
Baseline up approximately 31 days
|
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part B)
Zeitfenster: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part C)
Zeitfenster: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Heart Rate (Part A)
Zeitfenster: Baseline up approximately 31 days
|
Supine position
|
Baseline up approximately 31 days
|
|
Change from Baseline in Heart Rate (Part B)
Zeitfenster: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Heart Rate (Part C)
Zeitfenster: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
13. Juli 2018
Primärer Abschluss (Tatsächlich)
17. Januar 2019
Studienabschluss (Tatsächlich)
17. Januar 2019
Studienanmeldedaten
Zuerst eingereicht
6. Juli 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. Juli 2018
Zuerst gepostet (Tatsächlich)
18. Juli 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
25. Februar 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. Februar 2019
Zuletzt verifiziert
1. Februar 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 16771
- I9K-MC-UCAA (Andere Kennung: Eli Lilly and Company)
- 2018-002337-38 (EudraCT-Nummer)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Ja
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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