Trial · NCT04020016
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Number analyzed indicates number of participants who were evaluable for this outcome measure in a particular group. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Number analyzed indicates number of participants who were evaluable for this outcome measure in a particular group. | hours (h) | MEDIAN |
| PRIMARY | Part 1: Terminal Elimination Half-Life (T1/2 el) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Overall number of participants analyzed is the number of participants with evaluable data for this outcome measure. Number analyzed indicates number of participants who were evaluable in a particular group. | h | MEDIAN |
| PRIMARY | Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Overall number of participants analyzed is the number of participants with evaluable data for this outcome measure. Number analyzed indicates number of participants who were evaluable in a particular group. | hour-nanogram per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Number analyzed indicates number of participants who were evaluable for this outcome measure in a particular group. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE) | From signing the informed consent form up to Day 4 | Safety analysis set (SAS) included all enrolled participants who had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | From signing the informed consent form up to Day 4 | SAS included all enrolled participants who had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Clinically Significant Findings in Vital Sign Parameters | From signing the informed consent form up to Day 4 | SAS included all enrolled participants who had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Clinically Significant Findings in Physical Examination Parameters | From signing the informed consent form up to Day 4 | SAS included all enrolled participants who had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) | From signing the informed consent form up to Day 4 | SAS included all enrolled participants who had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Clinically Significant Findings in Pulse Oximetry | Pre-dose and 1.5, 4, 5, and 8 hours post-dose in each dose level | SAS included all enrolled participants who had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2: Change From Baseline in Worst Itch Numerical Rating Scale (WI-NRS) | Baseline, Day 16 | As per the judgement of the safety committee, the Part 2 (MAD) was not conducted based on protocol defined criteria. Hence, this outcome was not assessed as Part 2 of the study was not conducted. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04020016/outcomes