A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orziloben (NST-6179) in Subjects with Intestinal Failure-Associated Liver Disease (IFALD)

Conditions

Subjects with Intestinal Failure-Associated Liver Disease (IFALD)

Brief summary

Part A: Safety and tolerability assessments will include, but not be limited to, subject-reported adverse events (AEs), blood and urine laboratory parameters, vital sign measurements, electrocardiograms (ECGs), physical examinations, and percentage of subjects discontinuing due to treatment-emergent adverse events (TEAEs)., Part A: Pharmacokinetic parameters will include, but not be limited to, area under the concentration-time curve from time 0 to last measurable concentration (AUC0-last), maximum observed concentration (Cmax), and time to reach Cmax (Tmax) on Day 1 and Day 14., Part B: Safety and tolerability assessments will include, but not be limited to, subject-reported AEs, blood and urine laboratory parameters, vital sign measurements, ECGs, physical examinations, and percentage of subjects discontinuing due to TEAEs., Part B: Pharmacokinetic parameters will include AUC0-last, Cmax, and Tmax on Day 1 and Day 28.

Related papers

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Interventions

DRUGThe dosage form of the NST-6179 placebo oral solution is a clear colourless to light yellow oral solution

DRUGOrziloben (NST-6179)

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part A: Safety and tolerability assessments will include, but not be limited to, subject-reported adverse events (AEs), blood and urine laboratory parameters, vital sign measurements, electrocardiograms (ECGs), physical examinations, and percentage of subjects discontinuing due to treatment-emergent adverse events (TEAEs)., Part A: Pharmacokinetic parameters will include, but not be limited to, area under the concentration-time curve from time 0 to last measurable concentration (AUC0-last), maximum observed concentration (Cmax), and time to reach Cmax (Tmax) on Day 1 and Day 14., Part B: Safety and tolerability assessments will include, but not be limited to, subject-reported AEs, blood and urine laboratory parameters, vital sign measurements, ECGs, physical examinations, and percentage of subjects discontinuing due to TEAEs., Part B: Pharmacokinetic parameters will include AUC0-last, Cmax, and Tmax on Day 1 and Day 28.	—

Measure

Time frame

Part A: Safety and tolerability assessments will include, but not be limited to, subject-reported adverse events (AEs), blood and urine laboratory parameters, vital sign measurements, electrocardiograms (ECGs), physical examinations, and percentage of subjects discontinuing due to treatment-emergent adverse events (TEAEs)., Part A: Pharmacokinetic parameters will include, but not be limited to, area under the concentration-time curve from time 0 to last measurable concentration (AUC0-last), maximum observed concentration (Cmax), and time to reach Cmax (Tmax) on Day 1 and Day 14., Part B: Safety and tolerability assessments will include, but not be limited to, subject-reported AEs, blood and urine laboratory parameters, vital sign measurements, ECGs, physical examinations, and percentage of subjects discontinuing due to TEAEs., Part B: Pharmacokinetic parameters will include AUC0-last, Cmax, and Tmax on Day 1 and Day 28.

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Countries

Belgium, Denmark, France

Outcome results

None listed