- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03913000
A Study to Evaluate ID-085 in People With Mild, Moderate, and Severe Kidney Disease
Open-label, Phase 1 Study to Investigate the Effects of Mild, Moderate, and Severe Renal Function Impairment on the Pharmacokinetics, Safety, and Tolerability of a Single Dose of ID-085
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Kiel, Tyskland, 24105
- CRS Clinical Research Services Kiel GmbH
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
All subjects:
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- Male and female subjects aged between 18 and 79 years (inclusive) at screening.
- Body mass index (BMI) of 18.0 to 34.0 kg/m2 (inclusive) at screening. Body weight of at least 50 kg.
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day-1. They must consistently and correctly use (from at least first dosing, during the entire study, and for at least 30 days after last study treatment intake) a highly effective method of contraception with a failure rate of < 1% per year and must use condoms, diaphragm or cervical cap with spermicide, or be sexually abstinent. Hormonal contraceptive must be initiated at least 1 month before study treatment administration.
Renal function impairment subjects:
• At screening and on Day -1, the stage of renal function impairment will be defined by Creatinine Clearance (CLcr) by the Cockcroft-Gault (C-G) equation:
- Mild renal function impairment: CLcr 60-89 mL/min (Group A).
- Moderate renal function impairment: CLcr 30-59 mL/min (Group B).
- Severe renal function impairment: CLcr <30 mL/min (Group C).
The stage of renal impairment will need to be confirmed at Day -1 and the CLcr values on Day -1 will need to remain within ± 25% of the screening value.
Healthy subjects:
• Normal renal function confirmed by a CLcr ≥ 90 mL/min. Normal renal function will need to be confirmed at Day -1 and the CLcr value on Day -1 will need to remain within ± 25% of the screening value.
Exclusion Criteria:
All subjects:
- Pregnant or lactating women.
- Known hypersensitivity to ID-085 or treatments of the same class, or any of its excipients.
- Known hypersensitivity or allergy to natural rubber latex.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Renal function impairment subjects:
- Subjects on dialysis.
- Hemoglobin concentration < 9 g/dL.
- Serum potassium concentration > 6 mmol/L.
- Platelet count < 100 × 10^6/mL.
- History of severe renal stenosis.
- History of clinically relevant bleeding disorder.
- Gastrointestinal bleeding within 2 weeks prior to screening.
- Presence of unstable diabetes mellitus.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: ID-085 single dose
Administration of the study treatment 200 mg to renally impaired subjects will be done by severity, starting with group A (mild), and followed by group B (moderate), C (severe) and D (healthy subjects).
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Hard capsules for oral administration formulated at a strength of 200 mg
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t)
Tidsramme: Up to Day 3 after treatment administration
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Will be derived by non-compartmental analysis of the plasma concentration-time profiles
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Up to Day 3 after treatment administration
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The plasma AUC from zero to infinity (AUC0-inf), calculated with the apparent λz
Tidsramme: Up to Day 3 after treatment administration
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Will be derived by non-compartmental analysis of the plasma concentration-time profiles
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Up to Day 3 after treatment administration
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The maximum plasma concentration (Cmax)
Tidsramme: Up to Day 3 after treatment administration
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Will be derived by non-compartmental analysis of the plasma concentration-time profiles
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Up to Day 3 after treatment administration
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The time to reach Cmax (tmax)
Tidsramme: Up to Day 3 after treatment administration
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Will be derived by non-compartmental analysis of the plasma concentration-time profiles
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Up to Day 3 after treatment administration
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Apparent total body clearance (CL/F)
Tidsramme: Up to Day 3 after treatment administration
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Will be derived by non-compartmental analysis of the plasma concentration-time profiles
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Up to Day 3 after treatment administration
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Apparent volume of distribution (Vz/F)
Tidsramme: Up to Day 3 after treatment administration
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Will be derived by non-compartmental analysis of the plasma concentration-time profiles
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Up to Day 3 after treatment administration
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ID-085-103
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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