- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03341884
A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants
A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Ipatasertib in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Subjects
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Florida
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Miami, Florida, Stati Uniti, 33014
- Clinical Pharmacology of Miami, Inc.
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Tennessee
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Knoxville, Tennessee, Stati Uniti, 37920
- New Orleans Center for Clinical Research
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Texas
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San Antonio, Texas, Stati Uniti, 78215
- American Research Corporation Inc.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- In good health (except for specific inclusion criteria related to hepatic impairment), as determined by the Investigator, based on no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram, and vital signs
- Females will not be pregnant or breastfeeding, and must be either postmenopausal or agree to use a study-approved method of contraception from the time of signing the informed consent until 30 days after discharge
- Males will either be sterile or agree to use male condom with spermicide from check-in (Day -1) until 90 days following the dose of study drug
Additional Inclusion Criteria for Healthy Subjects Only:
- Liver enzyme tests must be less than or equal to the upper limits of normal
Additional Exclusion Criteria for Hepatic Impaired Subjects Only:
- Hepatic impairment must have a Child-Pugh score of 5 to 6 (mild), 7 to 9 (moderate), or 10 to 15 (severe) and have stable hepatic insufficiency within 1 month prior to Screening
Exclusion Criteria:
- History of ulcerative colitis or stomach or intestinal surgery or resection
- History of unstable diabetes mellitus
- History of alcoholism or drug addiction within 1 year prior to Check-in (Day -1)
- Use of oral, implantable, transdermal, or injectable contraceptives from the time of signing the informed consent (females only) or 10 days prior to Check-in through 45 days after the dose administration
- Poor peripheral venous access
- Receipt of blood products within 2 months prior to check-in
Additional Exclusion Criteria for Healthy Subjects Only:
- Use of any tobacco- or nicotine-containing products within 6 months prior to check-in and during the entire study
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
Additional Exclusion Criteria for Hepatic Impaired Subjects Only:
- Any evidence of progressive liver disease that has worsened or is worsening within 1 month prior to the screening visit
- Participant has shown evidence of hepatorenal syndrome
- Ascites requiring paracentesis
- Participant has required treatment for GI bleeding within 12 months prior to Check-in
- Participant has required additional medication for hepatic encephalopathy within the 12 months (6 months for severe hepatic impairment) prior to check-in
- Total bilirubin levels >6 mg/dL
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Normal Hepatic Function
Participants with normal hepatic function will be administered a single oral dose of ipatasertib (100 mg).
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A single oral dose of 100 mg ipatasertib will be administered.
Altri nomi:
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Sperimentale: Mild Hepatic Impairment
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) will be administered a single dose of ipatasertib (100 mg).
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A single oral dose of 100 mg ipatasertib will be administered.
Altri nomi:
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Sperimentale: Moderate Hepatic Impairment
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) will be administered a single dose of ipatasertib (100 mg).
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A single oral dose of 100 mg ipatasertib will be administered.
Altri nomi:
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Sperimentale: Severe Hepatic Impairment
Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) will be administered a single dose of ipatasertib (100 mg).
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A single oral dose of 100 mg ipatasertib will be administered.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Area Under the Plasma Concentration-Time Curve (AUC) from 0 to Infinity (AUC0-inf) of Ipatasertib
Lasso di tempo: up to Day 15
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AUC0-inf is defined as AUC extrapolated from Hour 0 to infinity of ipatasertib in the plasma.
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up to Day 15
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Maximum Observed Plasma Concentration (Cmax) of Ipatasertib
Lasso di tempo: up to Day 15
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Maximum observed concentration of ipatasertib as determined by measuring drug concentration in blood samples over time.
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up to Day 15
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Percentage of Participants with Treatment-Emergent Adverse Events (AE)
Lasso di tempo: up to Day 15
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Preexisting conditions which worsen during a study are also considered as adverse events.
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up to Day 15
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Time to Reach Maximum Observed Concentration (tmax) of Ipatasertib
Lasso di tempo: up to Day 15
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Time from dose administration to observed maximum serum concentration for ipatasertib as determined by measuring drug concentration in blood samples over time.
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up to Day 15
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AUC from 0 to last measurable concentration (AUC0-t)
Lasso di tempo: up to Day 15
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Area under the plasma concentration-time curve from Hour 0 to the last measurable concentration of ipatasertib.
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up to Day 15
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Half-life (t1/2) of Ipatasertib
Lasso di tempo: up to Day 15
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Half-life of ipatasertib is the time elapsed for the drug concentration to decrease by half as determined by measuring drug concentration in blood samples over time.
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up to Day 15
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Apparent Plasma Clearance (CL/F) of Ipatasertib
Lasso di tempo: Up to Day 15
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Apparent clearance (CL/F) of ipatasertib, where CL is clearance and F is bioavailability (relative amount of extravascularly-administered drug that reaches systemic circulation unchanged).
Determined by measuring drug concentration in blood samples over time.
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Up to Day 15
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Apparent Volume of Distribution (V/F) of Ipatasertib
Lasso di tempo: up to Day 15
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Apparent volume of distribution (V/F) during the terminal phase of ipatasertib.
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up to Day 15
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GP40200
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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