- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02940379
A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol
A Two-cohort, Open-label, Fixed-sequence, Two-period, Two-treatment Pharmacokinetic Interaction Study of Repeated Oral Doses of Sotagliflozin on a Single Dose Cocktail of Metoprolol and Midazolam Used as Probe Substrates for CYP2D6 and CYP3A Activities, Respectively, in Healthy Subjects
Primary Objective:
To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A activities using a CYP probe cocktail of metoprolol and midazolam.
Secondary Objective:
To assess the clinical and laboratory safety of sotagliflozin coadministered with the cocktail probes as compared to that of cocktail probes alone.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Tennessee
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Knoxville, Tennessee, Forente stater, 37920
- Investigational Site Number 840001
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion criteria :
- Male or female healthy subjects, between 18 and 55 years of age, inclusive.
- Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m^2, inclusive.
- Normal vital signs, electrocardiogram (ECG), and laboratory parameters
- Female subjects must use a double contraception method during the study, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. The accepted double contraception methods include the use of one of the following contraceptive options: (1) condom; (2) diaphragm or cervical/vault cap; (3) spermicide in addition to the use of one of the following: a) Intrauterine device (IUD); b) Vasectomized partner; c) Sexual abstinence. Hormonal contraception is NOT acceptable in this study.
Exclusion criteria:
Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
- Blood donation, any volume, within 2 months before inclusion.
- Symptomatic postural hypotension.
- Presence or history of drug hypersensitivity, allergic disease or asthma diagnosed and treated by a physician.
- History or presence of drug or alcohol abuse.
- If female, pregnancy or breast-feeding.
- Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Any oral contraceptives during the screening period or for at least 15 days prior to the first dose of Period 1; any injectable contraceptives or hormonal intrauterine devices within 12 months prior to the first dose of Period 1; or topical controlled delivery contraceptives (patch) for 3 months prior to the first dose of Period 1.
- Any contra-indications to metoprolol, according to the applicable labeling.
- Any contra-indications to midazolam, according to the applicable labeling.
- Any consumption of citrus (grapefruit, orange, etc.) or their juices within 5 days before inclusion.
- Any history or presence of deep leg vein thrombosis or embolism or a recurrent or frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Cohort 1
Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 1 of Sotagliflozin plus cocktail) after 3 days
|
Farmasøytisk form: tablett Administrasjonsvei: oral Pharmaceutical form: HCl syrup Route of administration: oral Pharmaceutical form: tablet Route of administration: oral |
Eksperimentell: Cohort 2
Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 2 of Sotagliflozin plus cocktail) after 3 days
|
Farmasøytisk form: tablett Administrasjonsvei: oral Pharmaceutical form: HCl syrup Route of administration: oral Pharmaceutical form: tablet Route of administration: oral |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Assessment of midazolam pharmacokinetic (PK) parameter: Area under the curve (AUC)
Tidsramme: Day 1 to Day 2 of Treatment A Period
|
Day 1 to Day 2 of Treatment A Period
|
Assessment of midazolam PK parameter: AUC
Tidsramme: Day 11 to Day 12 of Treatment B Period
|
Day 11 to Day 12 of Treatment B Period
|
Assessment of metoprolol PK parameter: AUC
Tidsramme: Day 1 to Day 3 of Treatment A Period
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Day 1 to Day 3 of Treatment A Period
|
Assessment of metoprolol PK parameter: AUC
Tidsramme: Day 11 to Day 13 of Treatment B Period
|
Day 11 to Day 13 of Treatment B Period
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Assessment of PK parameter: maximum plasma concentration (Cmax)
Tidsramme: Day 1 to Day 2 of Treatment A Period (midazolam)
|
Day 1 to Day 2 of Treatment A Period (midazolam)
|
Assessment of PK parameter: Cmax
Tidsramme: Day 11 to Day 12 of Treatment B Period (midazolam)
|
Day 11 to Day 12 of Treatment B Period (midazolam)
|
Assessment of PK parameter: Cmax
Tidsramme: Day 1 to Day 3 of Treatment A Period (metoprolol)
|
Day 1 to Day 3 of Treatment A Period (metoprolol)
|
Assessment of PK parameter: Cmax
Tidsramme: Day 11 to Day 13 of Treatment B Period (metoprolol)
|
Day 11 to Day 13 of Treatment B Period (metoprolol)
|
Assessment of PK parameter: time to reach Cmax (Tmax)
Tidsramme: Day 1 to Day 2 of Treatment A Period (midazolam)
|
Day 1 to Day 2 of Treatment A Period (midazolam)
|
Assessment of PK parameter: Tmax
Tidsramme: Day 11 to Day 12 of Treatment B Period (midazolam)
|
Day 11 to Day 12 of Treatment B Period (midazolam)
|
Assessment of PK parameter: Tmax
Tidsramme: Day 1 to Day 3 of Treatment A Period (metoprolol)
|
Day 1 to Day 3 of Treatment A Period (metoprolol)
|
Assessment of PK parameter: Tmax
Tidsramme: Day 11 to Day 13 of Treatment B Period (metoprolol)
|
Day 11 to Day 13 of Treatment B Period (metoprolol)
|
Assessment of PK parameter: terminal-half life (t1/2z)
Tidsramme: Day 1 to Day 2 of Treatment A Period (midazolam)
|
Day 1 to Day 2 of Treatment A Period (midazolam)
|
Assessment of PK parameter: t1/2z
Tidsramme: Day 11 to Day 12 of Treatment B Period (midazolam)
|
Day 11 to Day 12 of Treatment B Period (midazolam)
|
Assessment of PK parameter: t1/2z
Tidsramme: Day 1 to Day 3 of Treatment A Period (metoprolol)
|
Day 1 to Day 3 of Treatment A Period (metoprolol)
|
Assessment of PK parameter: t1/2z
Tidsramme: Day 11 to Day 13 of Treatment B Period (metoprolol)
|
Day 11 to Day 13 of Treatment B Period (metoprolol)
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Sykdommer i det endokrine systemet
- Sukkersyke
- Diabetes mellitus, type 2
- Hypoglykemiske midler
- Fysiologiske effekter av legemidler
- Adrenerge beta-antagonister
- Adrenerge antagonister
- Adrenerge midler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Anti-arytmimidler
- Antihypertensive midler
- Sentralnervesystemdepressiva
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Anestesimidler, intravenøst
- Anestesimidler, general
- Bedøvelsesmidler
- Beroligende midler
- Psykotropiske stoffer
- Hypnotika og beroligende midler
- Adjuvanser, anestesi
- Anti-angst midler
- GABA modulatorer
- GABA-agenter
- Sodium-Glucose Transporter 2-hemmere
- Sympatolytika
- Adrenerge beta-1-reseptorantagonister
- Midazolam
- (2S,3R,4R,5S,6R)-2-(4-klor-3-(4-etoksybenzyl)fenyl)-6-(metyltio)tetrahydro-2H-pyran-3,4,5-triol
- Metoprolol
Andre studie-ID-numre
- INT14972
- U1111-1184-8677 (Annen identifikator: UTN)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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