Single and Multiple Dose Study to Evaluate Safety and Pharmacokinetics of BMS-986533 in Healthy Participants and Assessments of Food and pH Effects on Relative Bioavailability, and Drug-Drug Interaction Potential in Healthy Participants
23. juli 2026 opdateret af: Bristol-Myers Squibb
A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986533 in Healthy Participants, an Open-label Assessment of Food and pH Effects on the Relative Bioavailability of BMS-986533, and an Open-label Study to Evaluate P-gp- and BCRP-mediated Drug-Drug Interaction Potential of BMS-986533 in Healthy Participants
The purpose of this study is to evaluate the safety and pharmacokinetics of BMS-986533 in healthy participants receiving single and multiple doses, to assess food and pH effects on the relative bioavailability of BMS-986533, and the P-gp and BCRP-mediated drug-drug interaction potential of the study drug
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
136
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: First line of the email MUST contain NCT # and Site #.
Undersøgelse Kontakt Backup
- Navn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefonnummer: 855-907-3286
- E-mail: Clinical.Trials@bms.com
Studiesteder
-
-
Nebraska
-
Lincoln, Nebraska, Forenede Stater, 68502
- Rekruttering
- Celerion Coorporate Office Nebraska
-
Kontakt:
- Allen Hunt, Site 0001
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Participants must have a body mass index (BMI) of 18 to 32.44 kg/m2, inclusive, and total body weight ≥ 50 kg.
- Female (as assigned at birth) participants who are not of childbearing potential must have documented proof of reproductive status.
- A male (as assigned at birth) who is sexually active with IOCBP must agree to follow instructions for method(s) of contraception as described and included in the ICF.
Exclusion Criteria:
- Participants must not have presence or history of any clinically relevant abnormality, condition, or disease of renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic (including history of angioedema or hypersensitivity reactions to medication).
- Participants must not have current or recent (within 3 months of study intervention administration) clinically significant GI disease.
- Participants must not have any major surgery within 3 months of study intervention administration.
- Participants must not have Any surgical or medical intervention that could possibly affect ADME of study intervention (eg, bariatric surgery, GI surgery).
- Other protocol defined inclusion/exclusion criteria applies.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm A
|
Specificeret dosis på specificerede dage
Specified dose on specified days
|
|
Eksperimentel: Arm B
|
Specificeret dosis på specificerede dage
Specified dose on specified days
|
|
Eksperimentel: Arm C
|
Specificeret dosis på specificerede dage
Specified dose on specified days
|
|
Eksperimentel: Arm D
|
Specificeret dosis på specificerede dage
Specified dose on specified days
Specified dose on specified days
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with Adverse Events (AE)
Tidsramme: Up to Day 47
|
Up to Day 47
|
|
|
Number of participants with Serious Adverse Events (SAE)
Tidsramme: Up to Day 47
|
Up to Day 47
|
|
|
Number of participants with Vital Sign Abnormalities
Tidsramme: Up to Day 27
|
Up to Day 27
|
|
|
Number of participants with Physical Examination Abnormalities
Tidsramme: Up to Day 27
|
Including neurological examination
|
Up to Day 27
|
|
Number of participants with Electrocardiogram (ECG) Abnormalities
Tidsramme: Up to Day 27
|
Up to Day 27
|
|
|
Number of participants with Clinical Laboratory Assessments Abnormalities
Tidsramme: Up to Day 27
|
Up to Day 27
|
|
|
Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Tidsramme: Up to Day 27
|
Up to Day 27
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum observed concentration (Cmax)
Tidsramme: Up to Day 26 from last dose
|
Up to Day 26 from last dose
|
|
|
Time of maximum observed concentration (Tmax)
Tidsramme: Up to Day 26 from last dose
|
Up to Day 26 from last dose
|
|
|
Area under the concentration-time curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))
Tidsramme: Up to Day 26 from last dose
|
Arm A, Arm B, and Arm C
|
Up to Day 26 from last dose
|
|
AUC from Time Zero Extrapolated to Infinite Time (AUC(INF))
Tidsramme: Up to Day 26 from last dose
|
Arm A and Arm C
|
Up to Day 26 from last dose
|
|
AUC from Time Zero to 24 Hours (AUC(0-24))
Tidsramme: Up to Day 9 from last dose
|
Arm A
|
Up to Day 9 from last dose
|
|
Elimination Half-Life (T-HALF)
Tidsramme: Up to Day 26 from last dose
|
Arm A, Arm B, and Arm C
|
Up to Day 26 from last dose
|
|
Apparent Total Body Clearance from Plasma (CLT/F)
Tidsramme: Up to Day 26 from last dose
|
Arm A, Arm B, and Arm C
|
Up to Day 26 from last dose
|
|
Apparent Volume of Distribution (Vz/F)
Tidsramme: Up to Day 26 from last dose
|
Arm A, Arm B, and Arm C
|
Up to Day 26 from last dose
|
|
AUC in 1 dosing interval (AUC (TAU))
Tidsramme: Up to Day 22 from last dose
|
Arm B, D
|
Up to Day 22 from last dose
|
|
Cerebrospinal fluid (CSF) concentrations
Tidsramme: Up to Day 13
|
Arm B
|
Up to Day 13
|
|
Ratio of total and unbound CSF to plasma concentration
Tidsramme: Up to Day 13
|
Arm B
|
Up to Day 13
|
|
Geometric mean ratio of Cmax
Tidsramme: Up to Day 26 from last dose
|
Arm C, D
|
Up to Day 26 from last dose
|
|
Geometric mean ratio of AUC(0-T)
Tidsramme: Up to Day 26 from last dose
|
Arm C, D
|
Up to Day 26 from last dose
|
|
Geometric mean ratio of AUC(INF)
Tidsramme: Up to Day 26 from last dose
|
Arm C, D
|
Up to Day 26 from last dose
|
|
Cmax of dabigatran in plasma
Tidsramme: Up to Day 18 from last dose
|
Arm D
|
Up to Day 18 from last dose
|
|
Cmax of rosuvastatin in plasma
Tidsramme: Up to Day 20 from last dose
|
Arm D
|
Up to Day 20 from last dose
|
|
AUC(0-T) of dabigatran in plasma
Tidsramme: Up to Day 18 from last dose
|
Arm D
|
Up to Day 18 from last dose
|
|
AUC(0-T) of rosuvastatin in plasma
Tidsramme: Up to Day 20 from last dose
|
Arm D
|
Up to Day 20 from last dose
|
|
AUC(INF) of dabigatran in plasma
Tidsramme: Up to Day 18 from last dose
|
Arm D
|
Up to Day 18 from last dose
|
|
AUC(INF) of rosuvastatin in plasma
Tidsramme: Up to Day 20 from last dose
|
Arm D
|
Up to Day 20 from last dose
|
|
Tmax of dabigatran in plasma
Tidsramme: Up to Day 18 from last dose
|
Arm D
|
Up to Day 18 from last dose
|
|
Tmax of rosuvastatin in plasma
Tidsramme: Up to Day 20 from last dose
|
Arm D
|
Up to Day 20 from last dose
|
|
T-HALF of dabigatran in plasma
Tidsramme: Up to Day 26 from last dose
|
Up to Day 26 from last dose
|
|
|
T-HALF of rosuvastatin in plasma
Tidsramme: Up to Day 20 from last dose
|
Arm D
|
Up to Day 20 from last dose
|
|
CLT/F of dabigatran in plasma
Tidsramme: Up to Day 18 from last dose
|
Arm D
|
Up to Day 18 from last dose
|
|
CLT/F of rosuvastatin in plasma
Tidsramme: Up to Day 27 from last dose
|
Up to Day 27 from last dose
|
|
|
Vz/F of dabigatran in plasma
Tidsramme: Up to Day 18 from last dose
|
Arm D
|
Up to Day 18 from last dose
|
|
Vz/F of rosuvastatin in plasma
Tidsramme: Up to Day 20 from last dose
|
Arm D
|
Up to Day 20 from last dose
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
13. juli 2026
Primær færdiggørelse (Anslået)
1. juni 2027
Studieafslutning (Anslået)
1. juni 2027
Datoer for studieregistrering
Først indsendt
1. juni 2026
Først indsendt, der opfyldte QC-kriterier
1. juni 2026
Først opslået (Faktiske)
5. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Metabolisme, medfødte fejl
- Genetiske sygdomme, medfødte
- Metaboliske sygdomme
- Dyslipidæmi
- Lipidmetabolismeforstyrrelser
- Lipidmetabolisme, medfødte fejl
- Hypoalphalipoproteinæmier
- Hypolipoproteinæmier
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Ernæringsmæssige og metaboliske sygdomme
- Lecithin kolesterol acyltransferase mangel
- Svovlforbindelser
- Organiske kemikalier
- Pyridiner
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Benzimidazoler
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Thiazoler
- Azoler
- Kulbrinter
- Amider
- Pyrimidiner
- Kulbrinter, halogeneret
- Sulfonamider
- Sulfoner
- Fluorobenzener
- Kulbrinter, fluoreret
- Dabigatran
- Rosuvastatin Calcium
- Famotidin
Andre undersøgelses-id-numre
- CN016-0001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.
Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
IPD-delingstidsramme
See Plan Description
IPD-delingsadgangskriterier
See Plan Description
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .