- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03918239
A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants.
12. November 2020 aktualisiert von: Shire
A Randomized, Open-label, Single-dose, Parallel-arm, Single-center, Phase 1 Study to Determine the Bioavailability of Lanadelumab Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Subjects
The purpose of this study is to evaluate bioavailability of lanadelumab (SHP643) following a single, 2 milliliter (mL) subcutaneous (SC) dose of 300 milligrams (mg) delivered by prefilled syringe (PFS) or auto injector (AI) in healthy adult participants.
Studienübersicht
Studientyp
Interventionell
Einschreibung (Tatsächlich)
190
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
-
-
Florida
-
Miami, Florida, Vereinigte Staaten, 33014
- Clinical Pharmacology of Miami, LLC
-
-
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 55 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- Ability to voluntarily provide written, signed, and dated informed consent to participate in the study.
- Age 18-55, inclusive, at the time of consent. The date of signature of the informed consent is defined as the beginning of the screening period. This inclusion criterion will only be assessed at the first screening visit.
- Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.
- Must be considered "healthy", per the investigator. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, and urinalysis.
- Body mass index between 18.5-33 kilogram per square meter (kg/m^2), inclusive, with a body weight greater than or equal to (>=) 45 kilogram (kg) (99 pounds [lbs]). This inclusion criterion will only be assessed at the screening visit and on Day -1.
- Willing and able to consume standardized meals during the confinement period of the study.
- All participants will be required to consume the identical meals on study days when serial PK blood samples are collected
Exclusion Criteria:
- Per the investigator, a history of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.
- Per the investigator, a current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to complete the study, or any condition that present's undue risk from the investigational product or procedures.
- Known or suspected intolerance or hypersensitivity to the investigational product, closelyrelated compounds, or any of the stated ingredients.
- Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product.
- Known history of alcohol or other substance abuse within the last year, per the investigator.
- Donation of blood or blood products (e.g. plasma or platelets) within 60 days prior to receiving the dose of investigational product.
Within 30 days prior to the dose of investigational product.
- Have used an investigational product (if elimination half-life is <6 days, otherwise 5 half lives).
- Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
- Confirmed systolic blood pressure (BP) >139 millimeters of mercury (mmHg) or <89 mmHg, and diastolic BP >89 mmHg or <49 mmHg.
- Twelve-lead ECG values demonstrating QTcF >450 milliseconds (msec) (males) or >470 msec (females) at the screening visit or Day -1. If QTcF exceeds 450 msec (males) or 470 msec (females), the ECG should be repeated 2 more times and the average of the 3 QTcF values should be used to determine the participants eligibility.
- Positive screen for drugs of abuse and/or disallowed drugs (i.e. amphetamines, benzodiazepines, barbiturates, cocaine, opiates, phencyclidine) at screening, or drugs of abuse or alcohol on Day -1. This screen will include marijuana.
- Male participants who consume more than 21 units of alcohol per week or 3 units per day. Female participants who consume more than 14 units of alcohol per week or 2 units per day. One alcohol unit=1 beer or 1 wine (5 ounces [oz) per 150 milliliter [mL]) or 1 liquor (1.5 oz/40 mL) or 0.75 oz alcohol.
- Positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody screen.
- Use of tobacco in any form (e.g. smoking or chewing) or other nicotine-containing products in any form (e.g. gum, patch, electronic). Ex-users must report that they have stopped using tobacco for at least 30 days prior to receiving the dose of investigational product.
- Routine consumption of more than 2 units of caffeine per day or participants who experience caffeine withdrawal headaches. One caffeine unit is contained in the following items: one 6 oz (180 ml) cup of coffee, two 12 oz (360 ml) cans of cola, one 12 oz cup of tea, and three 1 oz (85 g) chocolate bars. Decaffeinated coffee, tea, or cola are not considered to contain caffeine).
- Current use of any medication (including over-the-counter, herbal, or homeopathic preparations; with the exception of stable hormonal replacement therapy or hormonal contraceptives). Current use is defined as use within 14 days of the dose of investigational product. (Prior and Concomitant Treatment) for a list of permitted medications.
- Abnormal laboratory values considered clinically significant, as determined by the investigator, at screening or Day -1.
- History of any clinically significant surgery or procedure within 8 weeks of receiving the dose of investigational product, as determined by the investigator.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: SHP643 Prefilled Syringe (PFS)
Participants will receive 300 milligram (mg) of SHP643 PFS Subcutaneous (SC) injection into the abdomen on Day 1 during the in-house period (Day 1 to Day 5).
|
Participants will receive injection of SHP643.
Andere Namen:
|
|
Experimental: SHP643 Autoinjector (AI)
Participants will receive 300 mg of SHP643 AI SC injection into the abdomen on Day 1 during the in-house period (Day 1 to Day 5).
|
Participants will receive injection of SHP643.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of SHP643 in Plasma
Zeitfenster: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post dose
|
AUC(0-last) of SHP643 in plasma was reported.
Geometric mean and geometric coefficient of variation percent (CV%) was reported.
|
Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post dose
|
|
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-Inf) of SHP643 in Plasma
Zeitfenster: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
|
AUC(0-infinity) of SHP643 in plasma was reported.
Geometric mean and geometric coefficient of variation percent (CV%) was reported.
|
Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
|
|
Maximum Observed Plasma Drug Concentration (Cmax) of SHP643 in Plasma
Zeitfenster: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
|
Cmax is the maximum observed plasma concentration of SHP643 in Plasma was reported.
Geometric mean and geometric coefficient of variation percent (CV%) was reported.
|
Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
|
|
Minimum Time to Reach (Tmax) in Maximum Observed Plasma Drug Concentration of SHP643 in Plasma
Zeitfenster: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
|
Tmax of of SHP643 in plasma was reported.
|
Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
|
|
Terminal Half-Life (T1/2) of SHP643 in Plasma
Zeitfenster: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
|
t1/2 of of SHP643 in plasma was reported.
|
Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
|
|
Apparent Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (CL/F) of SHP643 in Plasma
Zeitfenster: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
|
CL/F of of SHP643 in plasma was reported.
Geometric mean and geometric coefficient of variation percent (CV%) was reported.
|
Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
|
|
Apparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vdz/F) of SHP643 in Plasma
Zeitfenster: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
|
Vdz/F of SHP643 in plasma was reported.
Geometric mean and geometric coefficient of variation percent (CV%) was reported.
|
Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
|
|
Terminal Elimination Rate Constant (Lambda z) of SHP643 in Plasma
Zeitfenster: Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
|
Lambda z of SHP643 in Plasma was reported.
Geometric mean and geometric coefficient of variation percent (CV%) was reported.
|
Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Zeitfenster: From start of study drug administration up to Day 112 (End of Study/Early Termination [EOS/ET])
|
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the investigational product (IP) or medicinal product.
A treatment-emergent AE (TEAE) was defined as any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the IP or medicinal product.
|
From start of study drug administration up to Day 112 (End of Study/Early Termination [EOS/ET])
|
|
Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points
Zeitfenster: Day 1, 14, 28, 56 and 112 (End of Study/Early Termination [EOS/ET])
|
Plasma samples were analyzed for presence of antidrug antibodies to SHP643.
Participants who developed positive results for SHP643 antibodies were reported.
|
Day 1, 14, 28, 56 and 112 (End of Study/Early Termination [EOS/ET])
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
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)
14. Mai 2019
Primärer Abschluss (Tatsächlich)
13. November 2019
Studienabschluss (Tatsächlich)
13. November 2019
Studienanmeldedaten
Zuerst eingereicht
15. April 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
15. April 2019
Zuerst gepostet (Tatsächlich)
17. April 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Dezember 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. November 2020
Zuletzt verifiziert
1. November 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- SHP643-102
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Ja
Beschreibung des IPD-Plans
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5).
These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD-Sharing-Zugriffskriterien
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/.
For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Art der unterstützenden IPD-Freigabeinformationen
- Studienprotokoll
- Statistischer Analyseplan (SAP)
- Einwilligungserklärung (ICF)
- Klinischer Studienbericht (CSR)
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
Nein
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 .
Klinische Studien zur Gesunde Freiwillige
-
3i SolutionsKGK Science Inc.Noch keine RekrutierungBioverfügbarkeit Heathy Volunteers | Pharmakokinetische ParameterKanada
-
Sarfez Pharmaceuticals, Inc.AbgeschlossenBioverfügbarkeit Heathy VolunteersVereinigte Staaten
-
Factors Group of Nutritional Companies Inc.IsuraAbgeschlossenSicherheit | Bioverfügbarkeit Heathy VolunteersKanada
-
Sarfez Pharmaceuticals, Inc.Abgeschlossen
-
Aziende Chimiche Riunite Angelini Francesco S.p.ASocraTec R&D GmbHAbgeschlossenBioverfügbarkeitsstudie | Bioverfügbarkeit Heathy Volunteers | BioäquivalenzDeutschland
-
National Research Council, SpainAktiv, nicht rekrutierendBioverfügbarkeit Heathy Volunteers | Bioverfügbarkeit und AUCSpanien
Klinische Studien zur SHP643
-
TakedaAktiv, nicht rekrutierendHereditäres Angioödem (HAE)Japan
-
TakedaAbgeschlossenHereditäres Angioödem (HAE)China
-
ShireAbgeschlossenGesunde FreiwilligeVereinigte Staaten
-
ShireAbgeschlossenHereditäres AngioödemVereinigte Staaten, Kanada, Deutschland, Ungarn, Spanien
-
ShireTakeda Development Center Americas, Inc.ZurückgezogenCOVID-19 Lungenentzündung
-
ShireTakeda Development Center Americas, Inc.AbgeschlossenAngioödemVereinigte Staaten, Frankreich, Niederlande, Spanien, Ungarn, Italien, Kanada, Polen, Japan, Deutschland
-
TakedaTakeda Development Center Americas, Inc.AbgeschlossenAngioödemVereinigte Staaten, Spanien, Niederlande, Ungarn, Italien, Kanada, Deutschland, Frankreich, Japan, Polen
-
ShireAbgeschlossenHereditäres Angioödem (HAE)Japan
-
ShireTakeda Development Center Americas, Inc.Nicht länger verfügbarAngioödem | Hereditäres Angioödem (HAE)Vereinigte Staaten, Kanada, Deutschland, Ungarn, Spanien