Trial · NCT07892469
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events (AEs) | From informed consent form signature through end of study (Day 7 ± 1 day after dosing, or longer if follow-up is required). | Number and percentage of participants with AEs |
| Primary | Incidence of serious adverse events (SAEs) | From informed consent form signature through end of study (Day 7 ± 1 day after dosing, or longer if follow-up is required). | Number and percentage of participants with SAEs |
| Primary | Blood pressure | Screening (Day -14 to Day -2), Baseline (Day -1); Day 1 predose and at 5 minutes, 10 minutes, 30 minutes, 1 hour, 4 hours, and 6 hours postdose; Day 2 (24 hours postdose); Day 3 (48 hours postdose); Day 4 (discharge) | Systolic and diastolic blood pressure will be measured in mmHg after at least 5 minutes of rest in the supine position. Blood pressure will be measured at the scheduled time points listed in the Time Frame; values at each scheduled time point will be reported separately. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Primary | Pulse rate | Screening (Day -14 to Day -2), Baseline (Day -1); Day 1 predose and at 5 minutes, 10 minutes, 30 minutes, 1 hour, 4 hours, and 6 hours postdose; Day 2 (24 hours postdose); Day 3 (48 hours postdose); Day 4 (discharge) | Pulse rate will be measured in beats per minute after at least 5 minutes of rest in the supine position. Pulse rate will be measured at the scheduled time points listed in the Time Frame; values at each scheduled time point will be reported separately. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Primary | Respiratory rate | Screening (Day -14 to Day -2), Baseline (Day -1); Day 1 predose and at 5 minutes, 10 minutes, 30 minutes, 1 hour, 4 hours, and 6 hours postdose; Day 2 (24 hours postdose); Day 3 (48 hours postdose); Day 4 (discharge) | Respiratory rate will be measured in breaths per minute after at least 5 minutes of rest in the supine position. Values at each scheduled time point listed in the Time Frame will be reported separately. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Primary | Body temperature | Screening (Day -14 to Day -2), Baseline (Day -1), Day 1 (predose and at 5 minutes, 10 minutes, 30 minutes, 1 hour, 4 hours, and 6 hours postdose), Day 2 (24 hours postdose), Day 3 (48 hours postdose), and Day 4 (discharge) | Body temperature will be measured in degrees Celsius (°C) at the scheduled time points listed in the Time Frame; values at each scheduled time point will be reported separately. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Primary | Number of Participants With Clinically Significant Physical Examination Abnormalities | Screening (Day -14 to Day -2), Baseline (Day -1) and Day 4 (discharge) | Physical examinations will be performed by organ system, including general appearance, lymph nodes, head and neck, chest, abdomen, and mental status. Any finding will be assessed by the investigator as clinically significant (CS) or not clinically significant (NCS). This outcome measure reports the number and percentage of participants with at least one CS physical examination abnormality at each scheduled time point; multiple organ-system abnormalities in the same participant will be aggregated and counted once for this outcome measure. If the screening examination is performed within 7 days before Baseline, the Baseline examination may not be repeated, per protocol. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Primary | Number of Participants With Clinically Significant Clinical Laboratory Abnormalities | Screening (Day -14 to Day -2), Baseline (Day -1) and Day 4 (discharge) | Clinical laboratory tests include hematology, blood chemistry, urinalysis, coagulation, and thyroid function tests, as specified in the protocol. Each laboratory abnormality will be assessed by the investigator as clinically significant (CS) or not clinically significant (NCS). This outcome measure reports the number and percentage of participants with at least one CS laboratory abnormality at each scheduled time point; multiple CS abnormalities in the same participant will be aggregated and counted once for this outcome measure. If screening laboratory tests are performed within 7 days before Baseline, the Baseline tests may not be repeated, per protocol. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Primary | Number of Participants With Clinically Significant 12-Lead ECG Abnormalities | Screening (Day -14 to Day -2), Baseline (Day -1), Day 1 (predose and at 30 minutes, 1 hour, 4 hours, and 6 hours postdose), Day 2 (24 hours postdose), Day 3 (48 hours postdose), and Day 4 (discharge) | Twelve-lead ECGs will be recorded after at least 5 minutes of rest in the supine position. ECG parameters include heart rate, PR interval, QRS duration, QT interval, QTcF, and RR interval. Each ECG finding will be assessed by the investigator as clinically significant (CS) or not clinically significant (NCS). This outcome measure reports the number and percentage of participants with at least one CS 12-lead ECG abnormality at each scheduled time point; multiple ECG abnormalities in the same participant will be aggregated and counted once for this outcome measure. If the screening ECG is performed within 7 days before Baseline, the Baseline ECG may not be repeated, per protocol. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Primary | Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score | Day 1 predose, immediately after injection, and at 5 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 10 hours, 24 hours after injection, and early withdrawal (within 24 hours after dosing). | MOAA/S score ranges from 0 to 5; lower scores indicate deeper sedation. |
| Primary | Visual analogue scale (VAS) craving score | Day 1 immediately after injection, and at 5 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 10 hours, 24 hours after injection, and early withdrawal (within 24 hours after dosing). | VAS craving score ranges from 0 to 10; 0 = no craving, 10 = extreme craving. |
| Primary | Number of Participants With Clinically Significant Thyroid Function Test Abnormalities | Screening (Day -14 to Day -2), Baseline (Day -1), and Day 4 (discharge) | Thyroid function tests include total triiodothyronine (TT3), total thyroxine (TT4), free triiodothyronine (FT3), free thyroxine (FT4), and thyroid stimulating hormone (TSH). Each test result will be assessed by the investigator as clinically significant (CS) or not clinically significant (NCS). This outcome measure reports the number and percentage of participants with at least one CS thyroid function test abnormality at each scheduled time point; multiple CS abnormalities in the same participant will be aggregated and counted once for this outcome measure. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Secondary | Plasma Cmax of NH302 and metabolites, if applicable | Day 1 (predose) through 48 hours postdose | Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. Cmax will be derived from the concentration-time data and reported in ng/mL for NH302 and for each metabolite separately. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Secondary | Plasma Tmax of NH302 and metabolites, if applicable | Day 1 (predose) through 48 hours postdose | Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. Tmax will be derived from the concentration-time data and reported in hours for NH302 and for each metabolite separately. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Secondary | Plasma AUC0-t of NH302 and metabolites, if applicable | Day 1 (predose) through 48 hours postdose | Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. AUC0-t will be calculated from time zero to the last quantifiable time point using the linear trapezoidal rule and reported in h·ng/mL for NH302 and for each metabolite separately. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Secondary | Plasma AUC0-inf of NH302 and metabolites, if applicable | Day 1 (predose) through 48 hours postdose | Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. AUC0-inf will be calculated as AUC0-t plus Clast/λz, where Clast is the last quantifiable plasma concentration and λz is the terminal elimination rate constant, and will be reported in h·ng/mL for NH302 and for each metabolite separately. The percentage of AUC0-inf obtained by extrapolation will also be reported. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Secondary | Plasma AUC_%Extrap of NH302 and metabolites, if applicable | Day 1 (predose) through 48 hours postdose | Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. The percentage of AUC0-inf obtained by extrapolation (AUC\_%Extrap) will be calculated as \[(AUC0-inf - AUC0-t) / AUC0-inf\] × 100% and reported as a percentage for NH302 and for each metabolite separately. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Secondary | Plasma Clearance (CL) of NH302 and Metabolites, if Applicable | Day 1 (predose) through 48 hours postdose | Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. CL will be calculated as the administered dose divided by AUC0-inf and reported in mL/h/kg for NH302. For metabolites, CL will be reported only if the administered dose and a reliable AUC0-inf are available; otherwise, metabolite concentration and AUC will be reported without CL. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Secondary | Plasma Apparent Volume of Distribution (Vz) of NH302 and Metabolites, if Applicable | Day 1 (predose) through 48 hours postdose | Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. Vz will be calculated as CL/λz, where CL is clearance and λz is the terminal elimination rate constant, and reported in mL/kg for NH302. For metabolites, Vz will be reported only if the administered dose and a reliable AUC0-inf and λz are available; otherwise, metabolite concentration and AUC will be reported without Vz. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Secondary | Plasma Terminal Elimination Rate Constant (λz) of NH302 and Metabolites, if Applicable | Day 1 (predose) through 48 hours postdose | Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. λz will be estimated by linear regression of the log-transformed plasma concentration versus time during the terminal elimination phase, using the negative slope, and will be reported in h-¹ for NH302 and for each metabolite separately. For metabolites, λz will be reported only if a reliable terminal elimination phase can be identified; otherwise, metabolite concentration and AUC will be reported without λz. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
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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