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- Sperimentazione clinica NCT02121860
PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers
An Open-Label Pharmacokinetic and Pharmacodynamic Study of a Single Dose of IDN-6556 in Subjects With Hepatic Impairment and in Matched Healthy Volunteers
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
Florida
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DeLand, Florida, Stati Uniti, 32720
- Avail Clinical Research
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Miami, Florida, Stati Uniti, 33136
- University of Miami
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Orlando, Florida, Stati Uniti, 32809
- Orlando Clinical Research Center
-
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
All Subjects:
- Male or female subjects 18 years of age or older, able to provide written informed consent, understand and comply with all scheduled visits, and other requirements of the study
- Body mass index (BMI) 18.0 - 40.0 kg/m2 and body weight >45 kg
- Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from Screening to one month after the last dose of study drug
Matched Healthy Volunteers:
- Medically healthy as determined by the Investigator
- Supine blood pressure ≤145/90 mmHg
- No significant uncontrolled systemic or major illness that, in the opinion of the Investigator, would preclude the subject from participating in and completing the study
Demographically comparable to subjects with hepatic impairment as follows:
- Mean body weight within ±15 kg
- Mean age within ±10 years
- Similar gender ratio
Subjects with Hepatic Impairment:
Evidence of hepatic disease
- Score ≥ 2 on one of the Child-Pugh parameters, or
- Histological or imaging diagnosis of cirrhosis, or
- Presence of esophageal varices, or
- Abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) levels
Meet one of the following criteria for Child-Pugh classification for hepatic impairment during Screening
- Mild hepatic impairment: Class A (Child-Pugh Scores 5-6 points)
- Moderate hepatic impairment: Class B (Child-Pugh Scores 7-9 points)
- Severe hepatic impairment: Class C (Child Pugh Scores 10-15 points)
- Supine blood pressure ≤160/100 mmHg
Exclusion Criteria:
All Subjects:
- Known infection with human immunodeficiency virus (HIV) upon serological testing
- Evidence of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, renal, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal product (e.g., inflammatory bowel disease, resections of the small or large intestine, etc.)
- History of febrile illness within 5 days prior to dosing Note: Subjects can be rescreened once afebrile and more than 5 days have elapsed since the febrile illness.
- Known ongoing drug abuse within one month prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during Screening and/or at Day -1
- Subjects with active or history of malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
- Dosing in another clinical trial within 30 days prior to the study drug administration
- If female: known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
Matched Healthy Volunteers:
- Evidence of clinically significant liver disease or liver damage (e.g., hepatitis B or C, autoimmune hepatitis, primary biliary cirrhosis, non-alcoholic fatty liver disease, elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that is considered clinically significant by the Investigator, etc.)
- Screening creatinine clearance <80 mL/min using the Cockcroft-Gault equation
- History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of >450 milliseconds (msec)
- History of regular alcohol consumption exceeding 28 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of spirits) within 6 months of Screening
Subjects with Hepatic Impairment:
- Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment during Screening period and up to Day -1 (e.g., advanced ascites, infection of ascites, fever, active gastrointestinal bleeding)
- History of liver transplant, or have a transjugular intrahepatic portosystemic shunt, and/or have undergone portacaval shunting
- History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of >480 milliseconds (msec)
- Screening creatinine clearance <50 mL/min using the Cockcroft-Gault equation
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 |
---|---|
Sperimentale: Chil-Pugh Class A
All subjects with mild hepatic impairment received a single 50 mg oral dose of IDN-6556
|
Altri nomi:
|
Sperimentale: Chil-Pugh Class B
All subjects with moderate hepatic impairment received a single 50 mg oral dose of IDN-6556
|
Altri nomi:
|
Sperimentale: Chil-Pugh Class C
All subjects with severe hepatic impairment received a single 50 mg oral dose of IDN-6556
|
Altri nomi:
|
Sperimentale: Normal Hepatic Function
All healthy volunteers subjects received a single 50 mg oral dose of IDN-6556
|
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
AUC
Lasso di tempo: 48 Hours
|
Area under the plasma concentration curve (AUC) to 12 hours post-dose (AUC0-12); AUC to the last observed plasma concentration (AUClast);
|
48 Hours
|
Cmax
Lasso di tempo: 48 Hours
|
Maximum concentration (Cmax)
|
48 Hours
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Levels of cCK18/M30
Lasso di tempo: predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose
|
Caspase-cleaved cytokeratin levels (cCK18M30)
|
predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose
|
Levels of Caspase 3/7 RLU
Lasso di tempo: predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose
|
Concentration of Caspase 3/7 Relative Light Units
|
predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Dave Hagerty, MD, Conatus Pharmaceuticals
Studiare le date dei record
Studia le date principali
Inizio studio
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 (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IDN-6556-08
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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