Trial · NCT03846843
Registered outcomes50
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 50
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum concentration (Cmax) of PAA and PAGN following described treatment | 6 months | Maximum concentration (Cmax) of PAA and PAGN following a single 5 g dose of OCR-002 oral solution under fed or fasting conditions as compared to a single 5 g IV dose of OCR-002 under fasting conditions in participants with cirrhosis (Child-Pugh Classes A and C). Plasma concentrations of PAA, PAGN and ornithine will be analyzed by non-compartmental PK methods. |
| Primary | Time to Cmax (Tmax) of PAA and PAGN | 6 months | Plasma concentrations of PAA, PAGN and ornithine will be analyzed by non-compartmental PK methods. |
| Primary | Area under the plasma concentration time curve over time (AUC0-t) of PAA and PAGN following described treatment | 6 months | Area under the plasma concentration time curve over time (AUC0-t) of PAA and PAGN following a single 5 g dose of OCR-002 oral solution under fed or fasting conditions as compared to a single 5 g IV dose of OCR-002 under fasting conditions in participants with cirrhosis (Child-Pugh Classes A and C). Plasma concentrations of PAA, PAGN and ornithine will be analyzed by non-compartmental PK methods. |
| Primary | AUC0-24 of PAA and PAGN following a single 5 g dose of OCR-002 oral solution under fed or fasting conditions as compared to a single 5 g IV dose of OCR-002 under fasting conditions in participants with cirrhosis (Child-Pugh Classes A and C) | 6 months | Plasma concentrations of PAA, PAGN and ornithine will be analyzed by non-compartmental PK methods. |
| Primary | AUC0-36 of PAA and PAGN following a single 5 g dose of OCR-002 oral solution under fed or fasting conditions as compared to a single 5 g IV dose of OCR-002 under fasting conditions in participants with cirrhosis (Child-Pugh Classes A and C) | 6 months | Plasma concentrations of PAA, PAGN and ornithine will be analyzed by non-compartmental PK methods. |
| Primary | AUC0-inf of PAA and PAGN following a single 5 g dose of OCR-002 oral solution under fed or fasting conditions as compared to a single 5 g IV dose of OCR-002 under fasting conditions in participants with cirrhosis (Child-Pugh Classes A and C) | 6 months | Plasma concentrations of PAA, PAGN and ornithine will be analyzed by non-compartmental PK methods. |
| Primary | Half-life (t1/2) of PAA and PAGN following a single 5 g dose of OCR-002 oral solution under fed or fasting conditions as compared to a single 5 g IV dose of OCR-002 under fasting conditions in participants with cirrhosis (Child-Pugh Classes A nd C) | 6 months | Plasma concentrations of PAA, PAGN and ornithine will be analyzed by non-compartmental PK methods. |
| Primary | Evaluate the effect of a high-fat meal on the Cmax of 5 g OCR-002 oral solution in participants with cirrhosis (Child-Pugh Classes A and C) | 6 months | Participants will fast overnight for at least 8 hours prior to receiving the high fat (approximately 50% of total calorie content of the meal) and high-calorie (approximately 800 to 1000 calories) test meal, which will be entirely consumed within 30 minutes or less. |
| Primary | Evaluate the effect of a high-fat meal on the AUC of 5 g OCR-002 oral solution in participants with cirrhosis (Child-Pugh Classes A and C) | 6 months | Participants will fast overnight for at least 8 hours prior to receiving the high fat (approximately 50% of total calorie content of the meal) and high-calorie (approximately 800 to 1000 calories) test meal, which will be entirely consumed within 30 minutes or less. |
| Primary | Evaluate the effect of a high-fat meal on oral bioavailability of 5 g OCR-002 oral solution in participants with cirrhosis (Child-Pugh Classes A and C) | 6 months | Participants will fast overnight for at least 8 hours prior to receiving the high fat (approximately 50% of total calorie content of the meal) and high-calorie (approximately 800 to 1000 calories) test meal, which will be entirely consumed within 30 minutes or less. |
| Primary | Cmax of PAA and PAGN following a single dose of OCR-002 oral solution under fasting conditions in participants with cirrhosis who have discontinued lactulose (Child-Pugh Classes A and C) | 6 months | Cmax of PAA and PAGN following a single dose of OCR-002 oral solution under fasting conditions in participants with cirrhosis who have discontinued lactulose (Child-Pugh Classes A and C) will be determined. |
| Primary | AUC of PAA and PAGN following a single dose of OCR-002 oral solution under fasting conditions in participants with cirrhosis who have discontinued lactulose (Child-Pugh Classes A and C) | 6 months | AUC of PAA and PAGN following a single dose of OCR-002 oral solution under fasting conditions in participants with cirrhosis who have discontinued lactulose (Child-Pugh Classes A and C) will be determined. |
| Primary | Urinary excretion of PAGN following a single dose of each treatment in participants with cirrhosis (Child-Pugh Classes A and C) | 6 months | Urinary excretion profile of PAGN following a single dose of each treatment in participants with cirrhosis (Child-Pugh Classes A and C) will be determined. |
| Primary | Cmax of OCR-002 immediate-release tablets over the course of TID dosing for 5 days | 5 days | Cmax of OCR-002 immediate-release tablets over the course of TID dosing for 5 days will be determined. |
| Primary | Cmax of PAA, PAGN, and ornithine following 3 times a day (TID) OCR 002 oral tablet administration for 5 days in participants with cirrhosis | 5 days | Cmax of PAA, PAGN, and ornithine following 3 times a day (TID) OCR 002 oral tablet administration for 5 days in participants with cirrhosis will be determined. |
| Primary | Ammonia-lowering (Tmax) effect of OCR-002 over the course of TID dosing for 5 days | 5 days | Ammonia-lowering (Tmax) effect of OCR-002 over the course of TID dosing for 5 days will be determined. |
| Primary | AUC of oral, immediate-release (IR) OCR 002 tablets | 5 days | AUC of oral, immediate-release (IR) OCR 002 tablets will be determined. |
| Primary | AUC of PAA, PAGN, and ornithine following 3 times a day (TID) OCR 002 oral tablet administration for 5 days in participants with cirrhosis | 5 days | AUC of PAA, PAGN, and ornithine following 3 times a day (TID) OCR 002 oral tablet will be determined. |
| Primary | Degree of fluctuation (Day 5) of OCR-002 immediate-release tablets | 5 days | Degree of fluctuation (Day 5) of OCR-002 immediate-release tablets will be determined. |
| Primary | Elimination rate constant (kel) of OCR-002 immediate-release tablets | 5 days | kel of OCR-002 immediate-release tablets will be determined. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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