- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03590860
A Study of LY3322207 in Healthy Participants and in Participants With Hypertension (High Blood Pressure)
22. februar 2019 oppdatert av: 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).
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
62
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Groningen, Nederland, 9728 NZ
- PRA Health Sciences
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: LY3322207 (Part A)
LY3322207 administered subcutaneously (SC)
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Administered by SC injection
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Placebo komparator: Placebo (Part A)
Placebo matching LY3322207 administered SC
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Administrert ved SC-injeksjon
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Eksperimentell: LY3322207 (Part B)
LY3322207 administered SC once weekly
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Administered by SC injection
|
Placebo komparator: Placebo (Part B)
Placebo matching LY3322207 administered SC once weekly
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Administrert ved SC-injeksjon
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Eksperimentell: LY3322207 (Part C)
LY3322207 administered SC in participants with hypertension
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Administered by SC injection
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants with One or More Serious Adverse Events (Part A)
Tidsramme: 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
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Number of Participants with One or More Serious Adverse Events (Part B)
Tidsramme: 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
|
Baseline up to approximately 9 weeks
|
Number of Participants with One or More Serious Adverse Events (Part C)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part A)
Tidsramme: Predose up approximately 31 days
|
Pharmacokinetics (PK): AUC of LY3322207
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Predose up approximately 31 days
|
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part B)
Tidsramme: 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)
Tidsramme: Predose up to approximately 9 weeks
|
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)
Tidsramme: Predose up approximately 31 days
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PK: Cmax of LY3322207
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Predose up approximately 31 days
|
Maximum Concentration (Cmax) of LY3322207 (Part B)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Baseline up approximately 31 days
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Supine position
|
Baseline up approximately 31 days
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Change from Baseline in Systolic Blood Pressure (SBP) (Part B)
Tidsramme: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
Change from Baseline in Systolic Blood Pressure (SBP) (Part C)
Tidsramme: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
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Change from Baseline in Diastolic Blood Pressure (DBP) (Part A)
Tidsramme: Baseline up approximately 31 days
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Supine position
|
Baseline up approximately 31 days
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part B)
Tidsramme: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part C)
Tidsramme: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
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Change from Baseline in Heart Rate (Part A)
Tidsramme: Baseline up approximately 31 days
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Supine position
|
Baseline up approximately 31 days
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Change from Baseline in Heart Rate (Part B)
Tidsramme: Baseline up to approximately 9 weeks
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Supine position
|
Baseline up to approximately 9 weeks
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Change from Baseline in Heart Rate (Part C)
Tidsramme: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. juli 2018
Primær fullføring (Faktiske)
17. januar 2019
Studiet fullført (Faktiske)
17. januar 2019
Datoer for studieregistrering
Først innsendt
6. juli 2018
Først innsendt som oppfylte QC-kriteriene
6. juli 2018
Først lagt ut (Faktiske)
18. juli 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. februar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. februar 2019
Sist bekreftet
1. februar 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 16771
- I9K-MC-UCAA (Annen identifikator: Eli Lilly and Company)
- 2018-002337-38 (EudraCT-nummer)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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