- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03961932
Safety and Pharmacokinetics of Linzagolix in Female Subjects With Normal and Impaired Renal Function
Evaluation of the Safety and Pharmacokinetics of a Single Dose of Linzagolix in Female Subjects With Normal and Impaired Renal Function
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is a Phase 1, non-randomized, open label, single-dose study to evaluate the effect of varying degrees of impaired renal function (i.e., mild, moderate, severe Renal Impairment (RI), and End-Stage Renal Disease (ESRD) on hemodialysis) on the PK, safety, and tolerability of linzagolix and its major metabolite, KP017.
Up to 40 adult female participants will be enrolled.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Florida
-
Orlando, Florida, Forente stater, 32809
- Clinical Site
-
-
Minnesota
-
Saint Paul, Minnesota, Forente stater, 55114
- Clinical Site
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Key Inclusion Criteria:
Renal Impaired Subjects
- Adult female, ≥ 18 years of age at screening
- Has a BMI ≥ 18.0 and ≤ 42.0 kg/m^2 and weight ≥ 40 kg, at screening
Aside from RI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, electrocardiograms (ECGs), and screening clinical laboratory profiles, as deemed by the Principal Investigator (PI) or designee
Subjects with mild, moderate, or severe RI:
Has estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) equation at screening as follows:
- Severe RI only: ≤ 29 mL/min/1.73m^2 not on hemodialysis
- Moderate RI only: 30 - 59 mL/min/1.73m^2
- Mild RI only: 60 - 89 mL/min/1.73m^2
Has a stable renal function with no clinically significant change in renal status at least 1 month prior to study drug administration and is not currently or has not been previously on hemodialysis for at least 1 year
Subjects with ESRD:
- Subject is maintained on a stable hemodialysis regimen at least 3 times a week for at least 3 months prior to dosing
Healthy Subjects
- Health adult female will be matched to subjects with RI
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee
- Baseline eGFR ≥ 90 mL/min/1.73m^2 at screening, based on the MDRD equation. Actual creatinine clearance, as determined by a 24-hour urine collection, may be used in place of or in conjunction with the MDRD equation at the PI's discretion
Key Exclusion Criteria:
Renal Impaired Subjects
- Had any major surgery within 4 weeks prior to dosing
- Presence of functioning renal transplant
- Has a surgical (e.g., hepatectomy, nephrectomy, digestive organ resection) or medical condition other than RI which might significantly alter the absorption, distribution, metabolism, or excretion of linzagolix and its metabolites, or which may jeopardize the subject's safety in case of participation in the study, in the opinion of the PI or designee
Healthy Subjects
- Has any clinically significant illness, as judge by the PI or designee, within 4 weeks prior to dosing
- Has laboratory values at screening or check-in which are deemed to be clinically significant (especially derangement within liver function test), unless agreed in advance by the PI and the Sponsor
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Normal Renal Function
Healthy participants with Normal Renal Function (estimated Glomerular Filtration Rate (eGFR) ≥ 90 mL/min/1.73m^2)
|
En enkeltdose på 200 mg linzagolix (2 tabletter á 100 mg) vil bli administrert oralt under fastende forhold
|
Eksperimentell: Mild Renal Impairment
Presence of Mild Renal Impairment (eGFR 60-89 mL/min/1.73m^2)
|
En enkeltdose på 200 mg linzagolix (2 tabletter á 100 mg) vil bli administrert oralt under fastende forhold
|
Eksperimentell: Moderate Renal Impairment
Presence of Moderate Renal Impairment (eGFR 30-59 mL/min/1.73m^2)
|
En enkeltdose på 200 mg linzagolix (2 tabletter á 100 mg) vil bli administrert oralt under fastende forhold
|
Eksperimentell: Severe Renal Impairment
Presence of Severe Renal Impairment (eGFR ≤ 29 mL/min/1.73m^2),
not on hemodialysis
|
En enkeltdose på 200 mg linzagolix (2 tabletter á 100 mg) vil bli administrert oralt under fastende forhold
|
Eksperimentell: End-Stage Renal Disease
Presence of End-Stage Renal Disease (ESRD) requiring hemodialysis
|
En enkeltdose på 200 mg linzagolix (2 tabletter á 100 mg) vil bli administrert oralt under fastende forhold
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Plasma pharmacokinetic (PK) parameter Cmax of linzagolix and of KP017
Tidsramme: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
|
Measurement of effect of renal impairment on PK of linzagolix and its metabolite KP017 by assessment of the maximum plasma concentration (Cmax).
Cmax directly determined from the plasma concentration-time profiles
|
predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
|
Plasma PK parameter Tmax of linzagolix and of KP017
Tidsramme: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
|
Measurement of effect of renal impairment on PK of linzagolix and its metabolite KP017 by assessment of the Time to reach Cmax (Tmax)
|
predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
|
Plasma PK parameter AUC0-t of linzagolix and of KP017
Tidsramme: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
|
Measurement of effect of renal impairment on PK of linzagolix and its metabolite KP017 by assessment of the AUC0-t (area under the concentration time curve, from time 0 to the last observed non-zero concentration)
|
predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
|
Plasma PK parameter T1/2 of linzagolix and of KP017
Tidsramme: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
|
Measurement of effect of renal impairment on PK of linzagolix and its metabolite KP017 by assessment of the T1/2 (Terminal half life)
|
predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Treatment emergent Adverse Events
Tidsramme: Day 1 to 14 days post-dose
|
Assessment of safety and tolerability of a single dose linzagolix in renal impaired subjects compared with healthy control subjects by assessing the number, frequency and severity of treatment emergent Adverse Events
|
Day 1 to 14 days post-dose
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: ObsEva SA, Geneva
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 18-OBE2109-010
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Nedsatt nyrefunksjon
-
Universitaire Ziekenhuizen KU LeuvenFullførtForekomst av utvidet renal clearance | Risikofaktorer for økt renal clearanceBelgia
-
Andrew B AdamsBristol-Myers SquibbFullført
-
University Health Network, TorontoFullførtGlomerulær filtreringshastighet | Renal blodstrømCanada
-
Oregon Health and Science UniversityFullført
-
Erling Bjerregaard PedersenUniversity of AarhusUkjentRenal rørtransportDanmark
-
Amai Charitable TrustUkjent
-
The Methodist Hospital Research InstituteUkjentAkutt (cellulær) renal allograft avvisningForente stater
-
Universitaire Ziekenhuizen KU LeuvenUkjent
-
Medical University of ViennaFullførtAcidose, Renal Tubular
-
Johns Hopkins UniversityFullførtKlinisk T1 nyremasseForente stater
Kliniske studier på Linzagolix
-
ObsEva SAAvsluttetEndometrioseForente stater, Canada, Puerto Rico
-
Kissei Pharmaceutical Co., Ltd.FullførtEndometrioseForente stater, Østerrike, Bulgaria, Tsjekkia, Frankrike, Polen, Romania, Spania, Ukraina, Ungarn
-
ObsEva SAFullførtNedsatt leverfunksjon | Friske deltakereForente stater
-
Kissei Pharmaceutical Co., Ltd.FullførtEndometrioseForente stater, Østerrike, Bulgaria, Tsjekkia, Frankrike, Polen, Romania, Spania, Ukraina
-
Kissei Pharmaceutical Co., Ltd.AvsluttetEndometrioseForente stater, Canada, Puerto Rico