Trial · NCT05217537
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine the AUC(0-48). Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Primary | AUC(0-48) of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Blood samples were collected and analyzed to determine the AUC0-48. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Primary | AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Omadacycline After IV Infusion | Pre-dose (At least 15 minutes prior to IV infusion), and 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine the AUClast. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Primary | AUClast of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Blood samples were collected and analyzed to determine the AUClast. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Primary | AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine AUC0-inf. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Primary | AUC0-inf of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Blood samples were collected and analyzed to determine AUC0-inf. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Primary | Cmax of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine Tmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Primary | Tmax of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Blood samples were collected and analyzed to determine Tmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Primary | Elimination Half-life Associated With the Terminal Slope of the Semilogarithmic Concentration-time Curve (t1/2) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine t1/2 and was calculated by using formula. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Primary | t1/2 of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Blood samples were collected and analyzed to determine t1/2. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Primary | Apparent Volume of Distribution During the Terminal Phase (Vz) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine Vz. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Primary | Systemic Clearance (CL) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Blood samples were collected and analyzed to determine CL. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data. |
| Secondary | Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), by Relationship to the Study Drug. | Up to Day 7 | An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was any event that had not been present before exposure to the study drug, or any event that had already been present but worsened in intensity or frequency after exposure. |
| Secondary | Number of Participants Reporting TEAE by Severity | Up to Day 7 | An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was any event that had not been present before exposure to the study drug, or any event that had already been present but worsened in intensity or frequency after exposure. |
| Secondary | Number of Participants Reporting TEAE, Serious Adverse Events (SAEs) and AE Leading to Discontinuation of Study Drug | Up to Day 7 | An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was any event that had not been present before exposure to the study drug, or any event that had already been present but worsened in intensity or frequency after exposure. An SAE was any adverse event that resulted in death, required hospitalization, persistent or significant disability, congenital anomaly. |
| Secondary | Number of Participants With Change From Baseline in Hematology Parameters | Up to Day 2 | Blood samples were collected for the assessment of complete blood count (CBC) including hemoglobin, hematocrit, leukocytes, platelets, mean cell volume, platelet count, white blood cell counts, and differential to include the absolute counts for neutrophils, lymphocytes, eosinophils, monocytes and basophils. |
| Secondary | Number of Participants With Change From Baseline in Serum Chemistry Parameters | Up to Day 2 | Blood samples were collected for the assessment of blood glucose, urea, creatinine, sodium, potassium, chloride, bicarbonate, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP), total bilirubin, total protein, albumin, creatine phosphokinase (CK), calcium, phosphate, cholesterol, urate, amylase, lipase and gamma-glutamyl transpeptidase (GGT). |
| Secondary | Number of Participants With Change From Baseline in Vital Signs | Up to Day 2 | Vital signs included blood pressure, heart rate, and oral body temperature and were collected at the specified timepoints. Vital signs were measured after participants had remained in a supine position for at least 5 minutes using an automated calibrated device. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05217537/registered