A Phase I Study to Evaluate the Food Effect on Ecnoglutide Tablet
A Randomized, Open-label, Multiple-dose, Multicenter Phase I Study to Evaluate the Food Effect on the Pharmacokinetics of Ecnoglutide Tablets in Chinese Adult Participants
The aim of the study is to evaluate food effect on pharmacokinetics of oral ecnoglutide tablets in Chinese participants
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
There are two parts in this study. Part I will assess the effect of high-fat meal, while eligible participants will be randomized and allocated to either cohort F1(fasting) or F2(with meal) in a ratio of 1:1 to receive oral ecnoglutide tablet for up to 14 days. Part II will assess the effect of different dosing conditions, while eligible participants will be randomized and allocated to either cohort T1(no intake after 30min of dosing) or T2(no intake after 60min of dosing) in a ratio of 1:1 to receive oral ecnoglutide tablet for up to 14 days.
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Phase 1
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Yao Li
- Telefonnummer: 010-67889253
- E-Mail: ra@sciwindbio.com
Studienorte
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Zhejiang Provincial People's Hospital
-
Kontakt:
- Yiwen Zhang
- Telefonnummer: 0571-85893643
- E-Mail: ra@sciwindbio.com
-
-
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Body mass index (BMI): 19.0 kg/m² ≤ BMI < 30.0 kg/m², with body weight ≥ 55 kg (male) or ≥ 50 kg (female);
- Participants of childbearing potential agree to have no plans for pregnancy during the entire study period and within 6 months after the last dose: female participants must be non-pregnant and non-lactating, with no plans to donate ova, and male participants must have no plans to donate sperm; all participants voluntarily use effective contraception, with female participants avoiding pregnancy and male participants avoiding causing pregnancy in their partners;
Exclusion Criteria:
- History of severe drug allergy (especially known or suspected allergy to any component of Ecnoglutide Tablets, regardless of the severity of previous allergic reactions), or severe atopic allergic disease/history (e.g., asthma, urticaria, eczematous dermatitis, etc.), or discretion by the investigator to have a severe allergic condition (e.g., allergy to two or more drugs/foods, or repeated allergic reactions requiring medical intervention);
- Diagnosis of overweight or obesity of endocrine origin, such as Cushing's syndrome;
- Diagnosis of diabetes mellitus of any type (excluding gestational diabetes mellitus);
- History of acute or chronic pancreatitis, pancreatic injury, symptomatic biliary disease, or other high-risk factors that may lead to pancreatitis;
- Diagnosis of other endocrine diseases of significant clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging showing C-TIRADS ≥ 4A), thyroid cancer, or a personal or family history of multiple endocrine neoplasia type 2 (MEN2);
- Occurrence of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, severe irritable bowel syndrome, celiac disease, recurrent dyspepsia, or clinically abnormal gastric emptying (e.g., pyloric obstruction), within 6 months prior to screening; or presence of gastrointestinal symptoms such as nausea, vomiting, diarrhea, or constipation at screening/before the first dose;
- Occurrence of severe hypoglycemia or recurrent symptomatic hypoglycemia (≥ 2 episodes within 6 months) (e.g., anxiety, dizziness, sweating, tremor, hunger, and poor concentration, etc.), within 6 months prior to screening;
- Diagnosis of malignant tumor within 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc., as discreted by the investigator to be clinically insignificant;
- History of depression, or other severe psychiatric illness, or suicidal ideation or suicidal behavior;
- Within 3 months prior to screening, participation in and use of any investigational drug, vaccine, special medical food, or invasive device clinical trial, or planned participation in other clinical trials during the study period;
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Experimental: F1
Day 1 to Day 14: Fast overnight for at least 10 hours before each dose, and take the tablet with 240 mL of plain water. No food intake is allowed within 4h after dose administration. |
oral, once daily for 7 days oral, once daily for 7 days |
|
Experimental: F2
Day 1 to Day 13: take breakfast within 30min before each dose, and then take the tablet with 240 mL of plain water. No food intake is allowed within 4h after dose administration. Day 14: take breakfast with high fat and high calorie |
oral, once daily for 7 days oral, once daily for 7 days |
|
Experimental: T1
Day 1 to Day 14: fast after 30min of dosing |
oral, once daily for 7 days oral, once daily for 7 days |
|
Experimental: T2
Day 1 to Day 14: fast after 60min of dosing |
oral, once daily for 7 days oral, once daily for 7 days |
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Maximum concentration
Zeitfenster: From Day1 to Day42
|
Cmax of ecnoglutide |
From Day1 to Day42
|
|
Minimum concentration
Zeitfenster: From Day1 to Day42
|
Cmin of ecnoglutide |
From Day1 to Day42
|
|
Area under the curve from time 0 to infinity
Zeitfenster: From Day1 to Day42
|
AUC0-∞of ecnoglutide |
From Day1 to Day42
|
|
Area under the curve from time 0 to 24h
Zeitfenster: From Day1 to Day42
|
AUC0-24h of ecnoglutide |
From Day1 to Day42
|
|
Area under the curve from time 0 to last quantifiable time point
Zeitfenster: From Day1 to Day42
|
AUC0-t of ecnoglutide |
From Day1 to Day42
|
|
Time to reach maximum concentration
Zeitfenster: From Day1 to Day42
|
Tmax of ecnoglutide |
From Day1 to Day42
|
Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The incidence of adverse events
Zeitfenster: From Day1 to Day42
|
From Day1 to Day42
|
|
|
Anti-drug antibody
Zeitfenster: From Day1 to Day42
|
ADA of ecnoglutide |
From Day1 to Day42
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Hauptermittler: Yiwen Zhang, Zhejiang Provincial People's Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- SCW0503-1013
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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