- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02121860
PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers
27 januari 2016 uppdaterad av: Conatus Pharmaceuticals Inc.
An Open-Label Pharmacokinetic and Pharmacodynamic Study of a Single Dose of IDN-6556 in Subjects With Hepatic Impairment and in Matched Healthy Volunteers
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C, respectively) and matched healthy volunteers with normal hepatic function.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
37
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
Florida
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DeLand, Florida, Förenta staterna, 32720
- Avail Clinical Research
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Miami, Florida, Förenta staterna, 33136
- University of Miami
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Orlando, Florida, Förenta staterna, 32809
- Orlando Clinical Research Center
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Chil-Pugh Class A
All subjects with mild hepatic impairment received a single 50 mg oral dose of IDN-6556
|
Andra namn:
|
Experimentell: Chil-Pugh Class B
All subjects with moderate hepatic impairment received a single 50 mg oral dose of IDN-6556
|
Andra namn:
|
Experimentell: Chil-Pugh Class C
All subjects with severe hepatic impairment received a single 50 mg oral dose of IDN-6556
|
Andra namn:
|
Experimentell: Normal Hepatic Function
All healthy volunteers subjects received a single 50 mg oral dose of IDN-6556
|
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
AUC
Tidsram: 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
Tidsram: 48 Hours
|
Maximum concentration (Cmax)
|
48 Hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Levels of cCK18/M30
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Dave Hagerty, MD, Conatus Pharmaceuticals
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2014
Primärt slutförande (Faktisk)
1 juli 2014
Avslutad studie (Faktisk)
1 juli 2014
Studieregistreringsdatum
Först inskickad
18 april 2014
Först inskickad som uppfyllde QC-kriterierna
22 april 2014
Första postat (Uppskatta)
24 april 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
24 februari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 januari 2016
Senast verifierad
1 januari 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IDN-6556-08
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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