- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07843693
A Study to Evaluate the Safety and Pharmacokinetics of Multiple Doses Upadacitinib, Tofacitinib, and Baricitinib in Healthy Adult Volunteers
A Phase 1 Open-label, Multiple Dose Study of Upadacitinib, Tofacitinib, and Baricitinib in Healthy Subjects to Evaluate Pharmacodynamic Biomarkers
This is a Phase 1, open label, five arm study to evaluate the pharmacodynamic effects of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adult participants.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Studiesteder
-
-
Illinois
-
Grayslake, Illinois, Forenede Stater, 60030
- Rekruttering
- Acpru /Id# 286751
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, Physical Exam (PE), vital signs, laboratory profile and a 12-lead Electrocardiogram (ECG).
- A female must not be pregnant, or breastfeeding and is not considering becoming pregnant, cryopreserving her eggs or donating eggs during the study or for approximately 30 days after the last dose of study treatment.
Exclusion Criteria:
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, two or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster, one or more prior episodes of disseminated herpes simplex (including eczema herpeticum) or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
- History or evidence of active tuberculosis (TB) disease or latent TB infection.
- Participant has prior exposure to upadacitinib, tofacitinib or baricitinib within the past 90 days.
- Participant requires any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis.
- Participant has used any medications, vitamins and/or herbal supplements within the 2-week period prior to study treatment administration.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm 1: Multiple doses of Upadacitinib
Upadacitinib will be administered once daily |
Oral Tablet |
|
Eksperimentel: Arm 2: Multiple doses of Tofacitinib
Tofacitinib will be administered twice daily |
Oral Tablet |
|
Eksperimentel: Arm 3: Multiple doses of Upadacitinib
Upadacitinib will be administered once daily |
Oral Tablet |
|
Eksperimentel: Arm 4: Multiple doses of Tofacitinib
Tofacitinib will be administered twice daily |
Oral Tablet |
|
Eksperimentel: Arm 5: Multiple doses of Baricitinib
Baricitinib will be administered once daily |
Oral Tablet |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Tidsramme: Up to 44 Days
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. |
Up to 44 Days
|
|
Average plasma concentration (Cavg) of Upadacitinib
Tidsramme: Up to 44 Days
|
Cavg of Upadacitinib |
Up to 44 Days
|
|
Average plasma concentration (Cavg) of Tofacitinib
Tidsramme: Up to 44 Days
|
Cavg of Tofacitinib |
Up to 44 Days
|
|
Average plasma concentration (Cavg) of Baricitinib
Tidsramme: Up to 44 Days
|
Cavg of Baricitinib |
Up to 44 Days
|
|
Area under the concentration-time curve over 24 hours (AUC24) of Upadacitinib
Tidsramme: Up to 44 Days
|
AUC24 of Upadacitinib |
Up to 44 Days
|
|
Area under the concentration-time curve over 24 hours (AUC24) of Tofacitinib
Tidsramme: Up to 44 Days
|
AUC24 of Tofacitinib |
Up to 44 Days
|
|
Area under the concentration-time curve over 24 hours (AUC24) of Baricitinib
Tidsramme: Up to 44 Days
|
AUC24 of Baricitinib |
Up to 44 Days
|
|
Maximum Observed Plasma Concentration (Cmax) of Upadacitinib
Tidsramme: Up to 44 Days
|
Cmax of Upadacitinib |
Up to 44 Days
|
|
Maximum Observed Plasma Concentration (Cmax) of Tofacitinib
Tidsramme: Up to 44 Days
|
Cmax of Tofacitinib |
Up to 44 Days
|
|
Maximum Observed Plasma Concentration (Cmax) of Baricitinib
Tidsramme: Up to 44 Days
|
Cmax of Baricitinib |
Up to 44 Days
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: ABBVIE INC., AbbVie
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- M26-625
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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